Reported trial results for Melanoma

Every Melanoma trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

181 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

NCT04201223 · results posted 18 June 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT04201223) involved families with children, comparing two approaches to sun safety education. One group received a programme called FLARE, while the other received standard sun safety education. A total of 180 parent-child pairs started in the FLARE group and 184 in the standard education group, making roughly 728 participants across both groups at the start. The trial tracked several things over time, including how often children got sunburned, how often they used sunscreen, and what protective clothing they wore. The reported data shows that for the main measure — how many times a child had a painful or red sunburn in the past month (scored from 0 to 5, where lower is better) — both groups started at similar levels (FLARE: 0.59, Standard: 0.63). Over the follow-up period, the FLARE group's reported scores trended lower, ending at around 0.27, while the standard education group's scores ended at around 0.53. For sunscreen use (scored 1–5, where higher means more frequent), the FLARE group's reported scores rose from 2.68 at the start to a peak of 3.79 before settling at 3.13 by the final follow-up, compared with the standard education group rising from 2.76 to a peak of 3.29 and ending at 3.02. Similar patterns were reported for sunscreen re-application, with the FLARE group's scores generally sitting slightly higher than the standard education group's across all time points. Scores for wearing long-sleeved shirts and long pants or skirts were broadly similar between the two groups throughout the trial. Skin tone scores (on an 11-point scale) remained low and close between the groups at all time points, meaning children in both groups generally had lighter skin tones throughout. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03554083 · results posted 4 May 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 64 people in total across three treatment groups — Arm A (15 people), Arm B (15 people), and Arm C (34 people). All participants started the pre-surgery treatment phase, though some did not go on to complete surgery or the post-surgery treatment phase. The trial was measuring two main things: whether patients had no detectable cancer remaining in the tissue removed during surgery (called a "pathologic complete response"), and how long patients went without their cancer coming back after surgery. The reported data shows that in the pre-surgery phase, the percentage of patients with no detectable cancer remaining in their removed tissue was 66.7% in Arm A, 13.3% in Arm B, and 38.2% in Arm C. For the time patients went without cancer returning after surgery, the reported median (the middle value in the group) was not reached for Arms A and C — meaning the data was not yet at a point where a midpoint figure could be calculated — while Arm B recorded a median of 40.8 months. For the secondary outcome, the reported data shows the number of participants who experienced more serious side-effect events (graded 3 or higher on a standard medical scale) was 12 in Arm A, 9 in Arm B, and 10 in Arm C. Several other planned measurements relating to biological markers in the blood and tumour tissue were listed but no numerical results were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT06101134 · results posted 9 April 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT06101134) enrolled 100 people with melanoma — 50 with metastatic melanoma (cancer that had spread) and 50 with resected melanoma (cancer that had been surgically removed). The trial was primarily measuring which route of administration participants preferred for their treatment: a subcutaneous injection (a shot given just under the skin) or an intravenous infusion (a drip through a vein). Participants answered a questionnaire about their experience after their fourth treatment cycle. The reported data shows that when asked which method they would prefer to continue receiving, 78% of participants in the metastatic melanoma group and 70.8% of participants in the resected melanoma group indicated they would prefer the subcutaneous (under-the-skin injection) route. The questionnaire also asked about things like pain or discomfort, how long the administration took, and how that affected time spent talking with their doctor or socialising with others. The reported data also shows that among the secondary measurements — which tracked unintended medical events — 47 out of 50 participants in each group experienced at least one adverse event (an unwanted medical occurrence of any kind). Serious adverse events (those resulting in death, hospitalisation, or significant disability) were reported in 16 participants in the metastatic melanoma group and 5 in the resected melanoma group. No deaths were reported in either group. Data for laboratory abnormalities and immune-related adverse events was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT06099782 · results posted 8 April 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 147 participants in total — 71 in one group and 76 in the other. The trial was designed to compare two ways of giving the cancer medicine pembrolizumab: as a drip into a vein (IV, the standard method) versus as an injection under the skin (subcutaneous, or SC), where it was combined with a second medicine called berahyaluronidase alfa to help the body absorb it. Rather than measuring whether the medicine treated cancer differently, the trial was focused on which method participants themselves *preferred*, and how satisfied they were with each approach. Every participant tried both methods in sequence before answering questionnaires about their experience. The reported data shows that, out of all participants who completed both methods and answered the preference questionnaire, 65.3% said they preferred the under-the-skin (SC) injection over the drip. When asked why they preferred the SC method, the most commonly reported reasons across both groups were that it required less time in the clinic and felt less emotionally distressing, with lower injection-site pain also noted by some. Regarding satisfaction with the SC method, the reported data shows that roughly 72% of participants in one group and 56% in the other said they were satisfied with it; for the IV drip, around 46% and 62% respectively reported being satisfied. When participants were then asked to choose which method they wanted to continue with going forward, the reported data shows 68% chose the SC injection and 32% chose the IV drip. The data for the number of participants who experienced any unwanted medical events (adverse events) was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT05105100 · results posted 6 April 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT05105100) enrolled 25 adults with melanoma, and all 25 completed the study. The trial was not testing whether a treatment worked in the usual sense — instead, it was a biological research study. Its goal was to examine blood samples to find patterns in genes and immune cells (specifically a type called T-cells) that might be linked to how patients respond to a type of cancer immunotherapy known as anti-PD-1 therapy. Researchers analysed these patterns at the start of the study (baseline) and again at 24 weeks. The reported data shows the following findings from the laboratory analyses. Fifty-two genes were identified at both the start of the study and at the 24-week mark as being potentially associated with response or resistance to the therapy. Twelve different sub-groups (sub-populations) of T-cells — a type of immune cell — were identified as potentially relevant to treatment response. When looking at changes in how T-cells multiply (clonal expansion) and how they are distributed across those sub-groups, the reported data shows a proportion of 0.08 (meaning roughly 8 in every 100 participants) showed a change associated with a response to the therapy. Additionally, two instances of what the researchers called "transcriptional migration events" were recorded — this refers to cases where an immune cell appeared to change its activity profile during treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03815058 · results posted 30 January 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT03815058) involved people with a type of skin cancer called melanoma. It tested two approaches: one group received a drug called pembrolizumab on its own, and another received pembrolizumab combined with an experimental drug called RO7198457. A small initial safety group of 6 people was enrolled first, followed by a randomised stage where 41 people were assigned to pembrolizumab alone and 84 to the combination. A further 10 people later crossed over to receive the combination treatment after initially being in the pembrolizumab-only group. The reported data shows that the main thing being measured was how long participants went without their cancer growing or spreading — called progression-free survival. For the pembrolizumab-only group, the reported median time was 7.9 months, and for the combination group it was 8.3 months. For the proportion of participants whose tumours shrank by a meaningful amount (called objective response rate), the reported figures were approximately 49% in the pembrolizumab-only group and 42% in the combination group. For overall survival (time from enrolment to death from any cause), a median figure was not reached for the pembrolizumab-only group, meaning not enough events had occurred to calculate it, while the combination group had a reported median of 62.2 months. How long those responses lasted (duration of response) was not reported as a calculable number for either group. Among the 10 people who crossed over to the combination, 40% were reported to have had a meaningful reduction in tumour size. Quality-of-life scores were also measured using a standard questionnaire, with baseline scores of around 65 (out of 100) for the pembrolizumab-only group and 73 for the combination group, and the reported changes from those baselines over time were relatively small in both directions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05002569 · results posted 8 January 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT05002569) enrolled 1,093 people with melanoma — 547 in Treatment 1 and 546 in Treatment 2. Participants were randomly assigned to one of the two treatment groups. The trial's main goal was to measure "Recurrence Free Survival" (RFS) — that is, how long people went without their cancer coming back or dying from any cause. It also tracked overall survival, how long people lived without the cancer spreading to distant parts of the body, and how participants fared on any follow-up treatment after the trial. The reported data shows that for the primary measure of Recurrence Free Survival, a result was only reported for Treatment 2, recorded as a median (middle value) of 33.84 months — meaning half of that group reached that point without a recurrence or death. No figure was reported for Treatment 1. For the remaining outcome measures — overall survival, spread of cancer to distant sites, and outcomes on follow-up treatment — the data was not reported for either group. Regarding safety-related events (unintended medical occurrences tracked during the trial), the reported data shows that 522 people in Treatment 1 and 520 in Treatment 2 experienced at least one such event; 483 in Treatment 1 and 438 in Treatment 2 had a serious event; 132 in Treatment 1 and 78 in Treatment 2 had an event that led to stopping treatment; 102 in Treatment 1 and 65 in Treatment 2 had an event considered related to the study drug; and 83 in Treatment 1 and 76 in Treatment 2 died. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT01004952 · results posted 7 January 2026

According to the results reported on ClinicalTrials.gov, this trial involved people who had a close family member (such as a parent, sibling, or child) diagnosed with melanoma — a type of skin cancer. These participants are referred to as "first-degree relatives," or FDRs. The study was split into two parts: a first group of 25 people and a second group of 60 people. In total, 94 people started the trial across both groups, and 78 completed it (all 25 in the first group and 53 of the 69 who started in the second group). The trial was looking at how these individuals make decisions about protecting themselves from ultraviolet radiation (UV light from the sun), including things like using sunscreen, seeking shade, wearing hats, and wearing protective clothing. The reported data shows that all 25 participants in the first group took part in in-depth interviews about their UV protection habits, while none of the second group were part of this interview stage. For the second part of the study — which looked at what thoughts and feelings might be connected to people's UV protection behaviours in real time — only the second group was assessed. The reported data shows that across the four behaviours measured (sunscreen use, shade-seeking, hat use, and protective clothing), the numbers of participants recorded were 9, 21, 23, and 10 respectively. The first group was not assessed for this part of the study, and no numerical results beyond participant counts were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04526899 · results posted 15 December 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04526899) enrolled 184 people across three groups: 94 participants received a combination of two treatments called BNT111 and cemiplimab, 46 received BNT111 on its own, and 44 received cemiplimab on its own. The trial was looking at how many participants in each group showed a measurable shrinkage or disappearance of their tumours, as assessed by an independent reviewing team who did not know which treatment each person had received. The reported data shows that for the combination group (BNT111 plus cemiplimab), 18% of participants had their tumours shrink or disappear by a meaningful amount — meaning their scans showed either a complete disappearance of detectable tumour or a reduction in tumour size of 30% or more. This was the main result the trial set out to measure for that group. For the other two groups — BNT111 alone and cemiplimab alone — the reported data notes that these results will be provided when final results are posted, so the numbers are not yet available. Several other planned measurements, including how long responses lasted, how long it took for a response to appear, and how long participants went without their disease getting worse, were also listed as not yet reported and are expected to be shared at a later date. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02706353 · results posted 21 November 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT02706353) involved people with metastatic melanoma (skin cancer that has spread to other parts of the body). It was a two-part study: a Phase 1 part, where small groups of participants received increasing doses of an injected treatment called APX005M (0.1 mg, 0.5 mg, 1 mg, 3 mg, or 10 mg) directly into a tumour, combined with another medicine called pembrolizumab given through a drip; and a Phase 2 part, which expanded enrolment at the chosen dose. In total, the reported data shows 34 people took part across all groups. The trial was primarily measuring how well the combination was tolerated at different doses, and how many participants showed a response to treatment. The reported data shows that, for the primary measure of identifying a recommended dose, 10 mg was recorded as the value reported for both the Phase 1 and Phase 2 groups. For the primary measure of overall response rate — meaning the percentage of participants whose cancer showed a measurable response — the reported figures varied by dose group: 0% at 0.1 mg, 0% at 0.5 mg, 33.3% at 1 mg, 66.7% at 3 mg, 50% at 10 mg, and 50% in the Phase 2 expansion group. For a secondary measure looking at a specific type of immune cell (CD8⁺ T cells) found within injected tumours, the reported changes in cell density (measured in cells per square millimetre) ranged widely across groups, from a decrease of 24.62 at 1 mg to increases of 1,409.18 at 0.5 mg and 415.92 at 10 mg, with 388.1 reported in the Phase 2 group. Regarding the secondary safety measure, the reported data shows the number of serious side-event recordings (recorded as Grade 3 or Grade 4 events, meaning more severe in a standard medical grading scale) were: 0 at 0.1 mg, 1 at 0.5 mg, 1 at 1 mg, 12 at 3 mg, 5 at 10 mg, and 28 in the Phase 2 expansion group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03901573 · results posted 22 October 2025

According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two drugs — NT-I7 and atezolizumab — in people with certain cancers. The study had two phases: an early phase (Phase 1b) testing different dose levels of NT-I7 to assess safety and find an appropriate dose, and a later phase (Phase 2a) looking at how many participants' tumours responded to treatment. In total, 31 people started the trial across all groups — 3 at the lowest dose level, 3 at the second, 7 at the third, 3 at the fourth, and 15 in the Phase 2 group. Not all participants completed the trial; 18 finished across all groups, while 13 did not complete it. The reported data shows that for the primary Phase 2a outcome — measuring how many participants had their tumour shrink or disappear (called an "objective response") — none of the 13 participants who received lower doses (120–840 µg/kg) had a confirmed response. In the higher-dose group (1,200 µg/kg, which included 15 participants), 2 had a confirmed response, while 9 had stable disease (tumour neither grew nor shrank significantly) and 7 had disease that progressed. For the secondary outcomes, the reported data shows that in the lower-dose group, the median time until the disease worsened was around 4.2 months, compared to 3.5 months in the higher-dose group. A measure called "disease control rate" — the percentage of people whose disease did not progress — was reported as 75% in the lower-dose group and 53.3% in the higher-dose group. Regarding the body's immune reaction to NT-I7 itself (called immunogenicity), only 1 out of 15 Phase 2 participants tested positive for antibodies against the drug; the data for some subgroups was not fully reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03729596 · results posted 31 July 2025

According to the results reported on ClinicalTrials.gov, this trial tested a drug called vobramitamab duocarmazine across 143 participants in total. Participants were divided into ten groups — five smaller "cohort" groups used in the early dose-finding stage of the trial, and five larger "expansion" groups focused on specific cancer types: prostate cancer (41 people), non-small cell lung cancer (21 people), triple-negative breast cancer (18 people), melanoma (21 people), and head and neck cancer (13 people). The trial was primarily measuring how many participants experienced adverse events (unwanted health events that occurred during the study) and whether certain dose levels caused particularly severe side effects. The reported data shows that adverse events were recorded for every participant across all ten groups — meaning all 143 people who started the trial had at least one adverse event noted. In the early dose-finding cohorts, the number of participants who experienced what are called "dose-limiting toxicities" (severe side effects serious enough to limit how much of the drug could be given) was: zero out of 3 in Cohort 1, one out of 6 in Cohort 2, one out of 7 in Cohort 3, zero out of 7 in Cohort 4, and one out of 6 in Cohort 5. For the secondary measures, the reported data shows that the percentage of participants whose tumours shrank meaningfully (known as the objective response rate) ranged from 0% in several cohorts up to 20% in Cohort 5, 15% in the lung cancer group, and 7.7% in the head and neck cancer group, with other groups between 0% and 4.9%. The median time until the disease progressed or death occurred (progression-free survival) ranged from 2.0 to 6.3 months across groups. Duration of response figures — how long a response lasted — were only reported for some groups and ranged from approximately 2.1 to 10.3 months; this figure was not reported for all groups. It is also worth noting that the reported data shows zero participants were recorded as having "completed" the trial across all groups — all participants are listed under "not completed," though the specific reasons for this are not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05116202 · results posted 18 July 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 110 people across five treatment groups. The majority (102 participants) were in Cohort 1, which compared four different immunotherapy combinations before surgery for a type of cancer affecting the lymph nodes: a control group receiving nivolumab plus ipilimumab (22 people), tobemstomig alone at 2100 mg (40 people), atezolizumab plus tiragolumab (20 people), and tobemstomig plus tiragolumab (20 people). A smaller Cohort 2 (8 people) received tobemstomig plus tiragolumab for a more advanced form of the disease. The trial measured how many participants showed a reduction in tumour cells after treatment, and how long participants went without their disease returning or worsening. The reported data shows that in Cohort 1, when tumour tissue was reviewed by an independent panel, the percentage of participants showing a meaningful reduction in tumour cells (called the pathologic response rate) was: 77.3% in the control group, 80.0% in the tobemstomig-alone group, 45.0% in the atezolizumab plus tiragolumab group, and 60.0% in the tobemstomig plus tiragolumab group. When local doctors assessed the same tissue, the figures were 81.8%, 75.0%, 50.0%, and 60.0% respectively. For Cohort 2, the reported response rate was 0% — meaning none of the eight participants showed a measurable shrinkage of their tumours according to the standard criteria used. For the time-based measures in Cohort 1, the median time without disease worsening or death was reported as 19.55 months for the control group and 22.51 months for the atezolizumab plus tiragolumab group; figures for the two tobemstomig-containing groups were not yet reached at the time of reporting. Similarly, overall survival data had not reached a calculable midpoint for any group at the time of the analysis. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT03400332 · results posted 19 June 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03400332) enrolled a total of 281 participants across two parts. Part 1 tested different doses of an investigational treatment — given either every four weeks (Q4W) or every two weeks (Q2W) — across seven groups ranging from 16 to 63 people per group, including one group that also received two additional medicines called nivolumab and ipilimumab. Part 2 was a randomised comparison involving 62 people who received the investigational treatment combined with nivolumab and ipilimumab, and 60 people who received a placebo (an inactive substance) combined with nivolumab and ipilimumab. The trial was primarily measuring what happened to participants during treatment in Part 1, including any unwanted medical events (called adverse events), serious medical events, and deaths. The reported data shows that in Part 1, nearly all participants across every dose group experienced at least one adverse event — for example, all 16 people in the lowest-dose group and all 20 people in one of the higher-dose groups. Serious adverse events (those involving hospitalisation, being life-threatening, or resulting in death) were also reported across all groups, ranging from 7 out of 12 participants in one group to 31 out of 63 in another. The number of participants who stopped treatment due to an adverse event ranged from 1 to 7 across the groups. Notably, zero participants in any Part 1 group were recorded as having a "dose-limiting toxicity" — meaning no dose was found to trigger the specific serious reactions that would have required the dose to be reduced according to the trial's rules. The reported data also shows that deaths from any cause occurred in large numbers across Part 1 groups, ranging from 8 out of 15 participants in one group to 53 out of 63 in another, though the data does not specify the cause of each death. A small number of participants in each group also had severe (Grade 3 or 4) abnormal laboratory test results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04221438 · results posted 8 June 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04221438) enrolled just 3 participants, all of whom received the same treatment sequence: medication with encorafenib and binimetinib before surgery, followed by surgery, and then the same medication again after surgery. The trial was primarily looking at whether the tumour was completely gone (no living cancer cells remaining) when surgeons examined the tissue removed during the operation — a measure called pathologic complete response. It also tracked how long participants went without their disease returning, how long they survived overall, and how their tumours appeared to respond on scans before surgery. The reported data shows that of the 3 participants who started and were treated, 2 showed a complete absence of viable tumour in the removed tissue (pathologic complete response), while 1 did not meet that definition. For the scan-based measure of response before surgery, 2 participants were recorded as having an objective response (meaning their tumours shrank or disappeared on imaging), and 1 was recorded without that level of response. The reported data shows a disease-free survival figure — the time from surgery until disease return or death — of 13.1 months, and an overall survival figure of 24 months; however, because these figures come from only 3 participants (and only 1 completed the full study), they should be understood as very limited individual-level observations rather than broad conclusions. Data for one planned measurement (CD8+ T cell and Ki-67 laboratory markers) was not reported in the submitted results. It is worth noting that with only 3 people enrolled and 2 not completing the study, this was an extremely small trial, and the reported numbers reflect the experiences of very few individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05061134 · results posted 21 May 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05061134) looked at two experimental medicines — ceralasertib (used alone or combined with durvalumab) — in people with cancer. The main part of the trial enrolled 100 people in the combination group and 51 in the ceralasertib-alone group. A separate biopsy sub-study enrolled 43 people in the combination group, where researchers took tumour tissue samples to see whether the treatment changed the number of a particular type of immune cell (called CD8+ T-cells) inside the tumour. The trial's two main goals were to measure how many participants' tumours shrank or disappeared (called the "objective response rate"), and to track those immune cell changes in the biopsy sub-study. The reported data shows that in the main study, 9.3% of participants receiving the combination of ceralasertib and durvalumab had their tumour shrink or disappear in a confirmed way, compared with 5.8% of those receiving ceralasertib alone. In the biopsy sub-study, the reported change in CD8+ T-cell levels in the centre of the tumour was approximately −0.98% and −0.45% (two separate measurements reported), meaning the level of those immune cells did not noticeably increase on average. For how long tumour responses lasted (duration of response), the data was not reported for any of the three groups. The time until a response was first seen was reported as approximately 3.5 months for the combination group, 3.6 months for the ceralasertib-alone group, and 3.7 months in the biopsy sub-study group. Tumour size on average increased by around 15.8%, 11.25%, and 17.93% respectively across the three groups at the measured time points, and the length of time participants went without their disease worsening (progression-free survival) was reported as approximately 2.0 months, 1.94 months, and 2.83 months across the three groups. It is also worth noting that the reported data shows zero participants were recorded as having "completed" the study across all groups, with all participants listed under "not completed" — the reasons for this were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02799095 · results posted 21 May 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT02799095) enrolled participants with advanced cancers, including melanoma and kidney cancer (renal cell carcinoma, or RCC). The trial tested a drug called nemvaleukin alfa, given alone or combined with another drug called pembrolizumab. It was run in three parts: Part A tested increasing doses of nemvaleukin alfa in 46 people to find a safe dose range; Part B expanded testing at the chosen dose in 47 people with melanoma and 27 people with kidney cancer; and Part C tested the drug in combination with pembrolizumab across several groups, enrolling a further 166 people. In total, several hundred participants took part across all parts. The trial was primarily measuring how often participants experienced medical events (called adverse events) after starting the study drug, including how serious those events were, and in Part A specifically, how often a type of serious reaction called a dose-limiting toxicity (DLT) — meaning a reaction severe enough to limit further dose increases — occurred. The reported data shows that in Part A, DLTs were recorded in 0 out of 5 participants at the lowest doses (0.1 and 0.3 mcg/kg), rising to 2 out of 8 participants at 3 mcg/kg, 3 out of 12 at 6 mcg/kg, 0 out of 3 at 8 mcg/kg, and 1 out of 7 at the highest tested dose of 10 mcg/kg. For the broader measure of any medical event that emerged or worsened after starting treatment (called treatment-emergent adverse events, or TEAEs), the reported data shows these were recorded in all 5 participants in the lowest dose Part A group, all 46 melanoma participants and all 27 kidney cancer participants in Part B, and 42 out of 42 participants in one of the larger Part C combination-therapy groups, among others. Severity breakdowns were also reported across all groups, though the full figures for some Part C groups were not completely available in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04526730 · results posted 6 May 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04526730) enrolled 17 people, all of whom received the neoadjuvant (pre-surgery) treatment being studied. Sixteen of the 17 participants completed the trial, while one did not finish. The trial was measuring several things: whether the cancer had completely disappeared from tissue samples taken at surgery (called a pathologic complete response), how many participants' tumours responded before surgery, how participants fared over the following year in terms of their cancer not returning, whether participants were alive at one year, and whether surgery had to be delayed because of problems. The reported data shows that 9 out of the 16 participants who completed all three study phases (pre-surgery treatment, surgery, and post-surgery treatment) were found to have no detectable viable tumour in their tissue samples at the time of surgery. For the secondary measurements, 10 participants showed a measurable response to treatment before surgery. The reported data shows a 1-year probability of the cancer not returning of 93 out of 100, and a 1-year overall survival probability of 94 out of 100 — meaning that is how likely participants were, on average, to be alive one year after starting treatment, based on the figures reported. One participant had their surgery delayed due to their cancer progressing. It is worth noting that this was a small trial with only 17 participants, so these numbers reflect a very limited group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT05665595 · results posted 6 April 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,402 people in total — 701 in each of two groups. One group received a combination of two medicines called pembrolizumab and vibostolimab, while the other group received pembrolizumab alone. The trial was designed to measure how long participants went without their cancer coming back (called "recurrence-free survival"), as well as to track any unwanted medical events (called adverse events) that occurred during the study, including any that led to a participant stopping treatment. The reported data shows that for the main outcome — the length of time before cancer recurrence or death — the values were listed as "NA" (not available) for both groups. This means the final numbers for that measure were not reported in the submitted results data. For the two secondary outcomes tracking adverse events, the reported data shows no figures were submitted at all for either group, so those results are also not available from this data. It is worth noting that, according to the results reported on ClinicalTrials.gov, zero participants in either group were recorded as having completed the study, which may reflect the timing of the data cut-off or how trial completion was defined — but no further explanation was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04698187 · results posted 2 April 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 44 participants, all of whom received a combination of two treatments: CMP-001 and nivolumab. The trial was designed to measure how many participants' tumours shrank or disappeared (called an "objective response"), as well as to track unwanted health events (called adverse events) that occurred during treatment. The reported data shows that none of the 44 participants were recorded as having "completed" the trial in the conventional sense — all 44 were listed under "not completed," which may reflect how the study's endpoint or follow-up was structured rather than participants simply dropping out. The reported data shows that 11.4% of participants — roughly 5 out of 44 people — had their tumour shrink or disappear based on scans reviewed by an independent team who did not know which treatment participants received. Among those who did show a response, the reported time from first treatment dose to that first response was approximately 2.89 months, as measured by both the independent review team and the treating doctors. The duration of response — meaning how long that response lasted — was listed as "not available" in the submitted data, so no figure was reported for that measure. Regarding unwanted health events during the trial, the reported data shows that all 44 participants experienced at least one treatment-emergent adverse event (an unwanted health event that occurred after starting treatment). Of those, 12 participants experienced a "serious" adverse event, and 1 participant experienced an adverse event that led to discontinuation or death. In terms of severity, 2 participants had mild (Grade 1) events, 18 had moderate (Grade 2) events, 21 had severe (Grade 3) events, 2 had life-threatening (Grade 4) events, and 1 had a Grade 5 event (death related to an adverse event). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02437136 · results posted 20 March 2025

According to the results reported on ClinicalTrials.gov, this trial tested a combination of two drugs — entinostat and pembrolizumab — across two stages. The first stage (Phase 1b) involved 22 people and was designed to find an appropriate dose. The second stage (Phase 2) enrolled 185 people across four separate groups (called cohorts), each made up of people with different types of cancer. All Phase 2 participants received entinostat 5 mg weekly combined with pembrolizumab. The main thing the Phase 2 stage was measuring was the "objective response rate" — that is, the proportion of participants whose tumours shrank by a meaningful amount or disappeared entirely according to standardised imaging criteria. The reported data shows that, for the primary measure, the percentage of participants whose tumours shrank significantly or disappeared was: 22.2% in Cohort 1, 9.2% in Cohort 2, 18.9% in Cohort 3, and 5.4% in Cohort 4. For a secondary measure — the "clinical benefit rate," which also counted people whose disease stayed stable for at least six months — the reported figures were 33.3% (Cohort 1), 14.5% (Cohort 2), 35.8% (Cohort 3), and 8.1% (Cohort 4). The reported data also shows the median length of time participants went without their disease getting worse: this was approximately 2.76 months in Cohort 1, 2.83 months in Cohort 2, 4.40 months in Cohort 3, and 1.91 months in Cohort 4. The number of participants still without disease progression at the six-month mark was 3, 17, 20, and 3 across the four cohorts respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03997474 · results posted 7 March 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03997474) enrolled 13 people in total across three groups — 9 participants in Cohort A, 2 in Cohort B, and 2 in Cohort C. The trial was testing a treatment called ATL001 in people with recurrent or metastatic melanoma (a type of skin cancer that had spread or come back). The primary focus was on tracking unwanted medical events (called adverse events) that appeared during treatment, to look at how often they occurred, how serious they were, and whether they were thought to be related to ATL001. The reported data shows that none of the participants were recorded as having formally "completed" the study — all 13 were listed under "not completed." The reported data shows that, for the primary outcome measuring adverse events in Cohort A (9 participants), 8 out of 9 experienced at least one treatment-related unwanted event of some kind, and 5 out of 9 experienced what were recorded as more significant events. In Cohort B, 2 out of 2 participants had recorded events across the measured categories. In Cohort C, 2 out of 2 also had recorded events. For one of the secondary outcomes — tumour response — the reported data shows that no participants across any of the three cohorts had a recorded tumour response (0 out of 9 in Cohort A, 0 out of 2 in Cohort B, and 0 out of 2 in Cohort C). Several other secondary outcomes — including changes in tumour size, time to response, disease control rate, and progression-free survival — had no numerical data reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05297565 · results posted 27 February 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 14 people across two groups — 6 participants in Arm A and 8 participants in Arm B. The trial was primarily focused on tracking the safety of the study treatments by recording whether participants experienced any unexpected medical events (called adverse events) or more serious medical events (called serious adverse events) during the study period. Five people in Arm A and six people in Arm B completed the trial, with one and two participants respectively not completing it. The reported data shows that in Arm A, all 6 participants experienced at least one adverse event that was considered related to the treatment. In Arm B, all 8 participants experienced at least one adverse event overall, and 2 of those 8 also experienced what were recorded as treatment-related adverse events of a more notable kind (based on the pattern in the data). No participants in either arm experienced a serious adverse event — that is, none died, none were considered at immediate risk of death, and none required hospitalisation as a result of a medical event during the trial. No treatment-related serious adverse events were reported for either group. It is worth noting that this was a small, early-stage trial with only 14 participants in total, and the numbers reported here reflect only what was observed and recorded in this specific study group. The reported data does not include detail on the nature or severity of the individual adverse events that occurred. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03665597 · results posted 10 February 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03665597) looked at how the cancer medicine pembrolizumab behaves in the body when given in two different ways: as an injection under the skin (subcutaneous, or "SC") and as a drip into a vein (intravenous, or "IV"). The trial had two main groups. Cohort A included 37 people who were assigned to one of six sequences that rotated between a subcutaneous injection at two different concentrations (130 mg/mL and 165 mg/mL) and an IV drip, so the same participants received different forms of the medicine at different times. Cohort B included 101 people who all received pembrolizumab as a 400 mg IV drip. The main things being measured were how much of the drug got into the bloodstream, how quickly it was absorbed, and how the body processed it over time. The reported data shows the following numbers for Cohort A. The total amount of drug the body was exposed to over time (a measure called AUC) was 507 mg·day/L for the 130 mg/mL subcutaneous injection, 480 mg·day/L for the 165 mg/mL subcutaneous injection, and 695 mg·day/L for the IV drip. The peak level of drug in the blood (the highest concentration reached) was reported as 28.6 mg/L for the 130 mg/mL SC injection, 26.8 mg/L for the 165 mg/mL SC injection, and 71.3 mg/L for the IV drip. The time it took to reach that peak was about 6.6 days for the 130 mg/mL SC injection, 8.4 days for the 165 mg/mL SC injection, and less than one day (0.02 days) for the IV drip, which is expected since the IV drip delivers the medicine directly into the bloodstream. When combining all Cohort A data, the reported bioavailability — meaning the proportion of the drug that actually reached the bloodstream after the subcutaneous injection compared to IV — was 66%. The rate at which the body cleared the drug was reported as 0.25 litres per day. No primary outcome numbers were separately reported for Cohort B participants in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04993677 · results posted 22 January 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04993677) enrolled 77 people across four groups: 21 with relapsed or treatment-resistant melanoma (skin cancer that had come back or stopped responding to prior treatment), 39 with uveal melanoma (a rarer form of eye-related melanoma), 9 with a type of lung cancer (non-small cell lung cancer, or NSCLC) where a protein marker called PD-L1 was present at low-to-moderate levels, and 8 with the same lung cancer type but where that marker was barely detectable. The trial's main goal was to measure how many participants' tumours shrank or disappeared — known as the "objective response rate" — according to standard imaging criteria. The reported data shows that, for the main outcome, none of the 21 participants in the relapsed/refractory melanoma group had a confirmed tumour response (0%), while 5% of the uveal melanoma group did. In the two lung cancer groups, the reported figures were 44% and 25% respectively. For a secondary measure called the "disease control rate" — which counts anyone whose tumours either responded or remained stable for at least five weeks — the reported percentages were 48% (relapsed/refractory melanoma), 62% (uveal melanoma), 67% (NSCLC with low-to-moderate PD-L1), and 88% (NSCLC with very low PD-L1). The trial also tracked unwanted medical events (adverse events): across all groups, between 8 and 37 participants in each group experienced at least one adverse event during the study period, and between 6 and 7 participants per group experienced a severe (Grade 3 or higher) adverse event. No participants were recorded as having completed the study, though the data does not explain why. It is worth noting that the group sizes — particularly the lung cancer groups with only 8–9 people — are very small, so these numbers represent a limited snapshot. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04382664 · results posted 14 January 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04382664) enrolled 156 people in total — 78 in a group receiving a vaccine called UV1 combined with two immunotherapy medicines (nivolumab and ipilimumab), and 78 in a group receiving just the two immunotherapy medicines without the vaccine. The trial was primarily looking at something called **progression-free survival (PFS)** — that is, how long participants went without their cancer getting worse or spreading, as assessed by an independent team reviewing scans. Several secondary things were also planned to be measured, including overall survival (how long participants lived), how many people's tumours shrank or disappeared (response rate), how long any such response lasted, and a review of safety-related observations. The reported data shows that for the primary measure — progression-free survival — 35 out of 78 participants in the UV1 plus immunotherapy group, and 34 out of 78 participants in the immunotherapy-only group, had a measurable result recorded. It is important to note that the actual survival time figures (such as median months without progression) do not appear to have been included in the structured data submitted to ClinicalTrials.gov, so those specific numbers cannot be described here. For all of the secondary outcome measures — including overall survival, response rate, duration of response, and safety observations — the reported data shows that no numerical results were submitted in the structured results section, so those figures are not available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04157517 · results posted 27 December 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04157517) tested a drug called modakafusp alfa — alone at various doses, and later combined with another drug called pembrolizumab — in people with solid tumour cancers. In total, 45 participants were enrolled across all groups: small groups of 3–6 people tested increasing doses of modakafusp alfa in a Phase 1b stage, 3 people took part in a Phase 2 safety lead-in combining both drugs, and a further 21 people were enrolled across two expansion groups in Phase 2 (9 in Cohort I and 12 in Cohort II). A tenth planned group (Cohort III) had no participants enrolled. The reported data shows that none of the participants were recorded as having "completed" the study — all were listed under "not completed," though the data does not explain the reasons for each individual case. The reported data shows that across the Phase 1b dose-escalation groups, every participant (all 21 people across the six dose levels) experienced at least one treatment-emergent adverse event — that is, a new or worsening medical problem that appeared after starting the study drug. Among those, the number who had more serious (Grade 3 or higher) events — meaning severe, life-threatening, or fatal — ranged from 1 out of 3 participants at the lowest dose up to 4 out of 6 at the highest dose tested in Phase 1b. Two participants at the highest Phase 1b dose (1.5 mg/kg) experienced what the trial defined as a "dose-limiting toxicity" — a medical problem serious enough to potentially prevent moving to a higher dose. Serious adverse events (those requiring hospitalisation or considered medically significant) were reported in between 1 and 4 participants per group across Phase 1b. In the Phase 2 safety lead-in group (3 participants on the combination), no serious adverse events were reported, though 2 participants had Grade 3 or higher events. For the Phase 2 expansion stage, the primary measure was overall response rate — the percentage of participants whose tumours shrank by a defined amount or disappeared entirely. The reported data shows that in Cohort I (9 participants), the overall response rate was 0.0%, meaning no participants in that group met the criteria for a measurable tumour response. In Cohort II (12 participants), the reported overall response rate was 16.7%, meaning approximately 2 out of 12 participants met the response criteria. No outcome data was reported for Cohort III, as no participants were enrolled. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03092453 · results posted 24 December 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03092453) tested a specialised vaccine called a Mature Dendritic Cell (DC) vaccine in people with cancer. Dendritic cells are a type of immune cell, and the vaccine was designed to try to train the body's immune system to recognise cancer. Five people started the trial, three completed it, and two did not finish. The trial was measuring whether the vaccine produced a specific immune response in the blood, how safe and tolerable it was, and how participants' cancer responded over time. The reported data shows that for the primary immune response measure — which looked at a particular type of immune cell (called peptide-specific T cells) in the blood — the recorded value was zero percent across all four participants who were measured. In other words, the test did not detect the expected immune cell response in any of those participants. For the safety and tolerability primary measure, the reported data shows three participants completed study treatment and two withdrew. For the secondary outcome looking at clinical (cancer) response, the reported data shows two participants had one type of response and three had another, though the specific response categories were not clearly labelled in the submitted data. For time to progression (how long before the cancer showed signs of advancing), the reported figures were 113 days and 80 days for two participants; the remaining values were listed as not available or not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03341143 · results posted 30 October 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, all of whom completed the study. Every participant received the same combination: a faecal microbiota transplant (FMT) — a procedure where gut bacteria from a donor are transferred to a patient — together with a cancer immunotherapy drug called pembrolizumab. The trial was primarily measuring the "objective response rate," meaning how many participants showed a meaningful shrinkage of their cancer according to standard imaging criteria. The reported data shows that, for the primary measure, 2 participants had a complete response (where all detectable signs of cancer disappeared from scans) and 1 participant had a partial response (where tumours shrank by at least 30%). For the secondary measures, the "disease control rate" — which counts complete responses, partial responses, and cases where the cancer neither grew nor shrank significantly — included those same 2 complete responses and 1 partial response, plus 10 participants whose disease was recorded as stable. The reported median time before disease progression was 9 months (median meaning the middle value if all results were lined up in order). At the 6-month mark, 61% of participants had not yet had their disease progress or died; by 12 months, that figure was reported as 34%. Regarding serious side effects, the reported data shows that 6 participants experienced grade III or IV toxicities (meaning severe or life-threatening side effects as classified by a standard medical grading scale), with individual events recorded across 5 separate categories — though a full breakdown of what those toxicities were was not reported in the structured data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01436656 · results posted 28 October 2024

According to the results reported on ClinicalTrials.gov, this trial tested a drug called encorafenib in people with advanced cancers, primarily melanoma and metastatic colorectal cancer. The trial had two main stages: a dose escalation phase (where researchers tested increasing amounts of the drug to find an appropriate dose) and a dose expansion phase (where selected doses were tested in larger groups). In total, 54 participants took part in the dose escalation stage across 11 different dose groups, and 53 participants took part in the dose expansion stage across 7 groups. The trial was primarily measuring how many participants experienced "dose-limiting toxicities" — that is, serious unwanted reactions to the drug serious enough to limit how much could be given — within the first 28 days of treatment. The reported data shows that during the dose escalation phase, most dose groups had zero or one participant with a dose-limiting toxicity. The highest dose tested (700 mg once daily) had 2 out of 2 participants experience such a reaction, which was the highest count recorded in that stage. During the dose expansion phase, the reported data shows that among participants with pre-treated melanoma receiving 450 mg once daily, 4 out of 16 participants had a dose-limiting toxicity — the highest count in that stage. Other expansion groups had between 0 and 3 participants with such reactions. As a secondary measure, the trial also tracked how many participants experienced any adverse events (unwanted health changes, whether minor or serious). The reported data shows that adverse events were recorded across all dose groups and all participants in both phases. For example, in the dose expansion phase, all 16 participants in the pre-treated melanoma group receiving 450 mg once daily experienced an adverse event, and 9 of those were classified as serious adverse events. The trial also measured how long participants went without their disease getting worse (called progression-free survival), though the data as reported on ClinicalTrials.gov appears incomplete for that measure and full figures were not available for all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02097225 · results posted 16 October 2024

According to the results reported on ClinicalTrials.gov, this trial tested a combination of three drugs — dabrafenib, trametinib, and onalespib — in people with cancer. The main goal was to find the highest dose of each drug that could be given together without too many serious side effects (called the "maximum tolerated dose"). A total of 22 participants took part across four different dose groups, with 3 people in the first group, 4 in the second, 6 in the third, and 9 in the fourth. The trial enrolled participants between July 2015 and June 2018. The reported data shows that the maximum tolerated doses identified were 150 mg for dabrafenib, 2 mg for trametinib, and 260 mg/m² for onalespib — these correspond to the highest dose level tested (Dose Level 4). In terms of unwanted reactions serious enough to be counted as "dose-limiting" (meaning they could require stopping or reducing the dose), the trial reported 0 such reactions at Dose Levels 1 and 2, 5 at Dose Level 3, and 1 at Dose Level 4. For the secondary outcomes, the reported data shows that 2 participants at Dose Level 3 had their tumours shrink by at least 30% (called a "partial response"), while no partial or complete responses were recorded in the other three dose groups. The reported median time before disease progressed or death occurred (known as "progression-free survival") was 1.6 months for Dose Level 1, 1.5 months for Dose Level 2, 3.9 months for Dose Level 3, and 2.7 months for Dose Level 4. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02027935 · results posted 8 October 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 7 participants, all of whom received the same treatment combination. That combination included a type of immune cell therapy (called CTL, or cytotoxic T lymphocytes — specialised cells grown in a lab to target melanoma), chemotherapy, a drug called aldesleukin (which supports immune cell activity), and ipilimumab (an immunotherapy drug also known by the brand name Yervoy). The trial was designed to look at how this combination performed and how long the transferred immune cells remained active in the body. The reported data shows that none of the 7 participants were recorded as having completed the trial — all 7 were listed under "not completed." Beyond that, the results are notably limited: the primary outcome measure, which was intended to capture information about the combined treatment approach, contains no reported measurements. Likewise, the secondary outcome — which aimed to assess how long the transferred immune cells persisted in the body — also has no figures recorded. The data was not reported for either of these outcome measures. Because no measurement data was submitted for the primary or secondary outcomes, it is not possible to describe what the trial found in numerical terms. The reported data shows only that 7 people started the study and none reached completion, with no further results available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05810740 · results posted 19 September 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 37 people in total — 19 in one group and 18 in the other. The trial was comparing two different doses of a medicine called binimetinib (15 mg and 45 mg) given as two separate formulations, referred to as the "reference formulation" and the "test formulation." Each participant took one formulation for five days, had a seven-day break, and then took the other formulation for five days. The trial was measuring how the drug moved through the body — specifically how much of it entered the bloodstream and how quickly it reached its highest level in the blood. The reported data shows the following for the primary measurements of drug exposure in the blood: the reference formulation had an AUClast (a measure of total drug exposure up to the last measurable point) of 1,786 h·ng/mL, while the test formulation recorded 1,723 h·ng/mL. When drug exposure was estimated out to an infinite time point (AUCinf), the reference formulation returned 1,834 h·ng/mL and the test formulation 1,784 h·ng/mL. The peak drug concentration in the blood (the highest level reached) was 388.0 ng/mL for the reference formulation and 362.2 ng/mL for the test formulation. The reported data also shows results for the secondary measurements. The time it took to reach that peak blood level was 1.0 hour for the reference formulation and 0.75 hours for the test formulation. The half-life — meaning the time for the drug level to fall by half — was approximately 13.0 hours for the reference formulation and 13.9 hours for the test formulation. The rate at which the drug was cleared from the body was reported as 0.053 per hour for the reference formulation and 0.050 per hour for the test formulation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01256359 · results posted 15 August 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 83 people in total — 41 in a group receiving docetaxel (a chemotherapy medicine) combined with a drug called AZD6244, and 42 in a group receiving docetaxel combined with a placebo (an inactive substitute). The trial was primarily measuring "progression-free survival" — that is, how long participants went without their disease getting worse or dying. It also tracked a number of secondary measures, including how many people were still progression-free at six months, how long people lived overall, and how many had their disease respond to treatment. The reported data shows that, for the primary measure, the median time without disease progression was 4.23 months in the docetaxel-plus-AZD6244 group and 3.93 months in the docetaxel-plus-placebo group. (Median means the midpoint — half the participants in each group had a shorter time, and half had a longer time.) For the six-month progression-free survival rate, the reported figures were 40% of participants in the AZD6244 group and 26% in the placebo group still without progression at that point. The reported data shows that median overall survival — how long participants lived from the start of the trial — was 9.5 months in the AZD6244 group and approximately 11.4 months in the placebo group. For tumour response (whether the disease visibly shrank), 1 participant in the AZD6244 group had a complete response and 12 had a partial response, compared with 0 complete responses and 6 partial responses in the placebo group, though the remaining participants in both groups had stable or progressing disease. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03620019 · results posted 12 August 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 25 adults with advanced (unresectable stage III or stage IV) skin melanoma who had not previously received a type of immunotherapy called a PD-1 inhibitor. All 25 participants completed the study. The trial was measuring changes in specific immune cells — both in the blood and in tumour tissue — to explore what happens in the body when the bone drug denosumab is given alone, and then in combination with a PD-1 inhibitor (pembrolizumab or nivolumab). Researchers also tracked how many participants responded to treatment and whether serious side effects occurred. The reported data shows that certain immune cells in the blood (called "recent thymic emigrants," a type of T cell) were measured in cells per microlitre at several time points. At the start of the study, CD4+ cells measured 2.69 and CD8+ cells measured 2.42; by week three (after denosumab alone), these figures were 2.55 and 1.92 respectively. Later in the study, during the combination treatment phase, CD4+ and CD8+ cell counts at weeks 16, 28, and 40 ranged from approximately 1.64 to 2.84 cells per microlitre across the different time points. For tumour tissue, the reported data shows participant counts across different response categories rather than precise cell-density figures for all time points. Regarding tumour response at 16 weeks, the reported data shows 2 participants had a complete response (tumours disappeared on scans), 5 had a partial response (tumours shrank by at least 30%), 5 were recorded in another category, and 5 in a further category. For serious side effects (called serious adverse events), the reported data shows 1 participant was recorded in each of three reported categories, though the breakdown of specific event types was not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02509598 · results posted 28 June 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants, with 23 completing the study and 1 not completing it. All participants received an injection of a radioactive tracing agent called Tc99m Tilmanocept (also known as Lymphoseek), and some also optionally received a blue dye. The trial was measuring how well this tracer could locate nearby lymph nodes (small glands that are part of the body's immune system) during surgery, as well as how well a type of pre-surgery scan called SPECT or SPECT/CT could spot those same nodes beforehand. The reported data shows that, on average, 3.30 lymph nodes per person were identified during surgery using the tracer. Out of 23 people who completed the study, 22 had at least one lymph node successfully located this way. For the pre-surgery scanning, 21 out of 23 participants went on to have a SPECT or SPECT/CT scan, and of those, 20 had at least one lymph node identified on the scan. The reported data shows that the scan found an average of 2.75 lymph nodes per person before surgery. When comparing the pre-surgery scan count to the during-surgery count, the reported difference was an average of −0.86 nodes per person, meaning the pre-surgery scan tended to identify slightly fewer nodes on average than were found during the operation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05003622 · results posted 24 June 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT05003622) enrolled 3 participants who received a medicine called encorafenib. The trial was designed to look at two main things: first, whether participants experienced what researchers call a "dose limiting toxicity" (DLT) during the first 28 days — meaning a side effect or abnormal test result serious enough to prevent the person from receiving at least three-quarters of their planned dose. Second, the trial tracked a range of other measures including side effects, and changes in blood, urine, and clotting test results over time. None of the 3 participants completed the trial. The reported data shows that none of the 3 participants experienced a dose limiting toxicity during the first 28 days. For the broader side effect tracking, a total of 53 treatment-emergent adverse events (that is, any unwanted health event that appeared after starting treatment) were recorded across all 3 participants, along with 3 serious adverse events and 2 deaths. The reported data also shows various counts of events related to dose changes or treatment stops, though the full breakdown of each individual sub-category was not clearly labelled in the submitted data. For blood test results, no participants showed a clinically notable worsening in blood cell counts or most chemistry markers, though 1 participant showed a notable shift in one chemistry value (urate). Clotting tests and urine tests were also tracked, with the reported numbers varying across participants and time points. It is important to note that with only 3 participants, this was a very small trial and the reported numbers reflect a very limited group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03817125 · results posted 6 June 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 14 people in total — 6 in the placebo-plus-nivolumab group and 8 in the SER-401-plus-nivolumab group. SER-401 is an experimental treatment designed to alter the mix of bacteria living in the gut (the "microbiome"), and it was given alongside nivolumab, a type of cancer immunotherapy drug, to people with melanoma. The trial was measuring things like unwanted side effects, changes in gut bacteria, and how participants' cancer responded over time. The reported data shows that, for the primary measure — the number of participants who experienced unwanted side effects (called adverse events) — 5 out of 6 people in the placebo group and 4 out of 8 in the SER-401 group had at least one such event recorded. Regarding gut bacteria changes, the SER-401 group showed a notably higher average number of new bacterial species appearing over time (reaching around 25–29 at later time points) compared to the placebo group (which stayed closer to 5–8). For tumour response, 4 out of 6 participants in the placebo group and 2 out of 8 in the SER-401 group met the criteria for an objective response. Disease remained controlled for at least 24 weeks in 5 placebo-group participants and 3 SER-401-group participants. The reported median time without disease progression was 15 months in the placebo group and 5.2 months in the SER-401 group. For overall survival, a median figure was not able to be calculated for the placebo group (reported as "NA"), while the SER-401 group had a reported median of 21.1 months. It is important to note that the trial was very small, and these numbers should be interpreted with great caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02107755 · results posted 21 May 2024

According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two treatments — ipilimumab (an immunotherapy drug) and stereotactic radiosurgery (a precise, targeted form of radiation) — in people with cancer. A total of 8 participants were enrolled, and all 8 completed the study. The trial was primarily measuring how long participants went without their disease getting worse (called "progression-free survival"), as well as tracking side effects and how well the tumour responded to treatment. The reported data shows that the progression-free survival result — measured using two different sets of assessment criteria (called mWHO and irRC) — was reported as 0.75 months for both. This means that, on average, the point at which disease progression was recorded came at around three weeks. For side effects, the data shows that 12 individual instances of serious side effects (graded as Grade 3 or Grade 4, meaning more severe in nature) were recorded, each involving 1 participant per instance — though it is not clear from the data whether these all involved different participants or overlapped. For several other outcomes that were planned to be measured — including objective response rate (how many participants' tumours shrank or disappeared) and rate of local treatment failure — no numerical results were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03551626 · results posted 18 March 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 552 adults who received a combination of two medicines — dabrafenib and trametinib — as a treatment in the setting of melanoma. Of those who started, 425 completed the study and 127 did not. The trial was primarily looking at how often participants experienced serious fever-related events, defined as a fever of 38°C or higher that was either classified as severe or life-threatening, led to a hospital stay, or caused someone to stop treatment permanently. It also tracked longer-term outcomes such as how long participants went without their disease coming back, how many were still alive at certain points in time, and how participants felt their quality of life had changed. The reported data shows that 7.6% of participants experienced at least one of those serious fever-related events, which was the trial's main measurement. For the secondary outcomes, the reported figures show that approximately 91.7% of participants were free from disease relapse at one time point, dropping to 57.5% at a later time point (the exact time points were not specified in the submitted data beyond being pre-set milestones). For overall survival — the proportion of participants still alive — the reported data shows 99.1% at an earlier time point and 92.6% at a later one. Regarding fever management more broadly, the data shows that 210 participants required some form of intervention for fever, including medications or treatment changes, and 87 participants stopped treatment permanently due to any side effect. The reported data also shows that participants' self-reported quality of life scores, measured using a melanoma-specific questionnaire (where higher scores mean better quality of life), showed small decreases from their starting scores across all measured time points, ranging from around −1.96 to −2.46 points on a scale of 0 to 64. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02678741 · results posted 12 March 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 26 participants, all placed in a single treatment group. The trial was looking at what happened when a vaccine called TLPLDC was added to a standard type of cancer treatment known as checkpoint inhibitor (CPI) therapy. The study measured two main things: the number and seriousness of unwanted side effects (called adverse events), and how participants' tumours responded to treatment. The reported data shows that when it came to side effects, 12 out of 26 participants experienced at least one adverse event that was graded using a standard medical scoring system (the CTCAE scale, which rates the severity of side effects). Across all participants, a total of 79 individual adverse events of this graded type were recorded, with no events reported in a third category (the data does not specify further detail on that category). Regarding how the trial ended, 6 participants completed the study, while 20 did not — with reasons including no clinical response (3 participants), progressive disease meaning their condition worsened (10 participants), and stable disease meaning their condition neither improved nor worsened significantly (2 participants). The reported data shows that tumour response was assessed in the treatment group using a standard measurement tool called RECIST criteria, which categorises tumour changes based on scans. The results recorded were: 2 participants with a complete response (all detectable tumour disappeared), 10 with progressive disease (tumours grew), 2 with a partial response (tumours shrank by at least 30%), and 2 with stable disease. No further breakdown of results was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02159066 · results posted 5 March 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT02159066) enrolled people with a type of cancer being treated with combinations of targeted medicines. It ran in two parts. In Part I, 75 participants received encorafenib plus binimetinib and had not previously had this type of treatment ("naive"), while 83 received the same two medicines but had been previously treated ("non-naive"). In Part II, smaller groups received those two medicines combined with a third drug: 38 people received ribociclib, 1 received infigratinib, 13 received capmatinib, and 6 received buparlisib. The trial was primarily measuring, in Part II, the proportion of participants whose tumours showed a confirmed response (either complete disappearance or a meaningful shrinkage of at least 30%) according to standard imaging criteria. The reported data shows that for the primary outcome — the proportion of participants with a confirmed tumour response in Part II — the figures were low across all groups. In the ribociclib combination group, 2.6% of participants met the response criteria; in the infigratinib, capmatinib, and buparlisib combination groups, the reported figure was 0% in each case. For one secondary outcome measuring dose-limiting toxicities (that is, side effects severe enough to limit the dose) in the first treatment cycle of Part II, 1 participant in the ribociclib group and 0 participants in the capmatinib group experienced this; figures for the infigratinib and buparlisib groups were not reported in the submitted data. Regarding adverse events (unwanted medical events) in Part I, all 75 naive participants and 78 of 83 non-naive participants experienced at least one adverse event, with serious adverse events recorded in 47 and 37 participants respectively. For Part II, the reported data shows adverse events were recorded in 37 of 38 ribociclib participants, 1 of 1 infigratinib participant, 12 of 13 capmatinib participants, and all 6 buparlisib participants, with serious adverse events in 19, 0, 6, and 4 participants in those groups respectively. It is important to note that none of the Part II groups were reported as having completed the study, and some secondary outcome data were not reported for all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05060003 · results posted 15 February 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT05060003) enrolled 7 participants into a single group. The trial was measuring whether a treatment could clear ctDNA — short for circulating tumour DNA, which refers to tiny fragments of cancer-related genetic material found in the blood — in people whose ctDNA test had come back positive. The main thing the trial was tracking was how many participants went from a positive ctDNA result to a negative one by a specific early point in their treatment. It also aimed to look at how long participants went without their cancer returning, how long before any cancer spread to distant parts of the body, how long participants survived overall, and how many experienced serious side effects related to treatment. The reported data shows that none of the 7 participants were recorded as having completed the trial, and all 7 were listed as "not completed." Regarding the actual outcome results — such as the ctDNA clearance rate, survival timeframes, and side effect counts — no numerical measurements were submitted or reported in the data provided to ClinicalTrials.gov. This means the specific figures for every outcome measure, both primary and secondary, were not available in the reported results. Because the trial ended early with no participants completing it and no outcome data was reported, there are no findings from this study that can be described in numbers. The reasons for non-completion are not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03625141 · results posted 8 February 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03625141) enrolled 80 people in total — 15 in a group (Cohort 1) receiving two drugs, cobimetinib and atezolizumab, and 65 in a second group (Cohort 2) receiving three drugs: cobimetinib, atezolizumab, and vemurafenib. All participants had melanoma that had spread to the brain. The trial was primarily measuring how many people in Cohort 2 showed a shrinkage or disappearance of their brain tumours, as assessed by scans. It also looked at responses in tumours outside the brain, how long any responses lasted, and how long participants went without their disease getting worse. Enrolment into Cohort 1 was stopped early by the sponsor, so several outcome measures were only fully analysed for Cohort 2. The reported data shows that, for the main outcome — tumour response inside the brain in Cohort 2 — 46.4% of participants showed a meaningful reduction or disappearance of their brain tumours on scans. For tumours outside the brain, the reported response rate was 20.0% in Cohort 1 and 56.9% in Cohort 2. When looking at the overall picture (both inside and outside the brain combined), the response rate was reported as 26.7% for Cohort 1 and 52.3% for Cohort 2. The reported data shows that the time participants went without their disease worsening (called progression-free survival) was approximately 1.81 months overall for Cohort 1 and 5.49 months for Cohort 2. For Cohort 2, the reported data shows that among those who did respond, responses in the brain lasted a reported median of around 6.7 months, outside the brain around 11.6 months, and overall around 7.4 months. Additionally, around 50.8% of Cohort 2 participants were reported to have their disease controlled (tumour shrinkage or stability) at 16 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03484923 · results posted 18 January 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03484923) enrolled 196 people across five treatment groups. Four groups were part of a randomised section — meaning participants were assigned to a treatment combination by chance — and one group was non-randomised. The five combinations tested all included a drug called PDR001, paired with one of four other drugs: LAG525, INC280, ACZ885, or LEE011. The trial's main goal was to measure the "overall response rate" — that is, the proportion of participants whose tumours shrank significantly or disappeared entirely during treatment. The reported data shows that, for the primary measure (overall response rate), the percentages of participants whose tumours shrank or disappeared were: 8.9% in the LAG525 + PDR001 randomised group, 4.7% in the INC280 + PDR001 group, 4.7% in the ACZ885 + PDR001 group, 6.8% in the LEE011 + PDR001 group, and 14.3% in the non-randomised LAG525 + PDR001 group. For secondary measures, the reported median time participants lived overall (overall survival) ranged from approximately 8.7 to 14.0 months across the five groups. The median time before the disease progressed or death occurred (progression-free survival) was reported as approximately 2.7 to 2.8 months across all groups. The "disease control rate" — the proportion of participants whose disease either shrank or stayed stable — ranged from about 15.6% to 33.3% depending on the group. The reported data also shows that, among participants who did have a measurable response, the length of time that response lasted (duration of response) ranged from a median of 217 days in the LEE011 + PDR001 group up to 941.5 days in the INC280 + PDR001 group, though it is worth noting these figures are based only on the smaller number of participants in each group who had a recorded response. Notably, the data shows zero participants were recorded as having "completed" the study in any group, meaning all participants either left the study early or were still being followed when data was collected. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03820986 · results posted 17 January 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03820986) enrolled 674 adults — 334 in the pembrolizumab plus lenvatinib group and 340 in the pembrolizumab plus placebo group. The trial was measuring how these two treatment combinations compared in people with a type of cancer, looking mainly at two things: how long participants went without their disease getting worse (called progression-free survival), and how long participants lived overall (called overall survival). No participants were recorded as having formally "completed" the study, which the reported data indicates is consistent with how this type of ongoing oncology trial tracks its milestones. The reported data shows that, for progression-free survival — the time from joining the trial until the cancer grew or the participant died — the pembrolizumab plus lenvatinib group had a median (the middle value in the group) of 9.1 months, compared with 4.2 months in the pembrolizumab plus placebo group. For overall survival, however, the reported median was 25.8 months in the pembrolizumab plus lenvatinib group and 39.5 months in the pembrolizumab plus placebo group. For the secondary outcomes, the reported data shows that 43.4% of participants in the lenvatinib group and 35.6% in the placebo group had their tumours shrink or disappear. Among those whose tumours did respond, the reported duration of that response was 26.9 months in the lenvatinib group; a figure was not reported for the placebo group. Regarding adverse events (unwanted medical occurrences during the trial), the reported data shows that 331 out of 332 treated participants in the lenvatinib group and 330 out of 338 in the placebo group experienced at least one adverse event. Of those, 104 participants in the lenvatinib group and 68 in the placebo group stopped their treatment due to an adverse event. The trial did not draw conclusions about whether these events were caused by the treatments. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04337931 · results posted 22 December 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04337931) enrolled a total of 45 participants across three groups: 12 in Cohort 1, 14 in Cohort 2, and 19 in Cohort 3 (which also received radiation therapy alongside the study treatment, sotigalimab). The trial was measuring how tumours responded to treatment, using standard imaging-based criteria to track whether tumours shrank, disappeared, or grew over time. The reported data shows that the main outcome being tracked — called the Overall Response Rate — measured the percentage of participants whose tumours either completely disappeared or shrank by more than 30%. In Cohort 1, this was reported as approximately 9.1% of participants (roughly 1 in 11). In Cohort 2, it was approximately 7.7% (roughly 1 in 13). In Cohort 3, it was reported as 0%. A secondary measure using a slightly different set of criteria designed for immunotherapy trials produced the same figures across all three groups. The reported data also shows that the median time participants went without their disease worsening was 1.87 months in Cohorts 1 and 3, and 3.48 months in Cohort 2. For the measure tracking how long any tumour response lasted, the data was not reported for Cohorts 1 and 2, and no figure was available for Cohort 3. Notably, the reported data shows that no participants were recorded as having formally "completed" the trial — all participants across all three groups were listed under "not completed," which may reflect the nature of how trial completion was defined for this study, though no further explanation was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03123783 · results posted 5 December 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03123783) tested a combination of two medicines — APX005M and nivolumab — in people with certain types of cancer, including non-small cell lung cancer (NSCLC) and melanoma. The trial had two phases. In the first phase (Phase 1b), 10 people took part across three groups receiving increasing doses of APX005M (0.03, 0.1, and 0.3 mg/kg) to find a safe dose range to carry forward. In the second phase (Phase 2), 133 people took part across four groups: 53 with a type of lung cancer that had not previously been treated with immunotherapy (Cohort 1), 38 with melanoma that had stopped responding to a prior immunotherapy (Cohort 2), and two groups totalling 42 people with lung cancer that had also stopped responding to prior immunotherapy (Cohorts 3A and 3B). The trial was measuring, among other things, how many participants' tumours shrank or disappeared — known as the "objective response rate" (ORR) — and how long participants went without their disease getting worse. The reported data shows that in Phase 1b, zero out of the 9 evaluable participants experienced a "dose-limiting toxicity" — meaning none experienced the specific severe reactions the trial was watching for when setting the dose. The maximum tolerated dose was recorded as "not available" in the submitted data. For the main Phase 2 measure — the percentage of participants whose tumours shrank or disappeared — the reported figures were approximately 16.7% in Cohort 1 (lung cancer, no prior immunotherapy) and approximately 15.2% in Cohort 2 (melanoma, prior immunotherapy), while 0% was reported in both Cohorts 3A and 3B (lung cancer, prior immunotherapy). The reported data also shows that the median time participants went without their disease getting worse (progression-free survival) was 4.11 months in Cohort 1, 1.97 months in Cohort 2, 3.43 months in Cohort 3A, and 3.65 months in Cohort 3B. The duration of response figures for Cohorts 1 and 2 were not reported in the submitted data. Regarding treatment-related events (side effects or adverse events that occurred during treatment), the reported data shows that 52 of 53 participants in Cohort 1, 36 of 38 in Cohort 2, all 14 in Cohort 3A, and all 28 in Cohort 3B experienced at least one such event — though the data as submitted does not break down the type or severity of these events in this section of the results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04589832 · results posted 22 November 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants, all of whom completed the study with none dropping out. The trial was testing a combination of two investigational drugs — PAC-1 and entrectinib — in people with a type of eye cancer called uveal melanoma that had spread to other parts of the body. The study was designed in two phases: a first phase to find the highest dose of PAC-1 that could be given alongside entrectinib without too many serious side effects, and a second phase to look at how many participants remained free from their cancer getting worse at three months. Only the first phase appears to have been completed based on the data submitted. The reported data shows that in the first phase, two dose levels of PAC-1 were tested — 625 mg and 600 mg — in combination with entrectinib. The reported results indicate that 600 mg was identified as the maximum tolerated dose, meaning it was the highest dose where fewer than one in three participants experienced a serious treatment-related reaction in the first cycle. For side effects, the reported data shows that out of the 6 participants, varying numbers experienced lower-level (grade 1 and 2) side effects across 12 different categories, with 4 participants reporting several of the more common ones and smaller numbers reporting others. The reported median overall survival — that is, the midpoint time from starting treatment until death from any cause — was 11.49 months. The Phase 2 outcome measures, including progression-free survival at 3 months, overall response rate, and duration of response, had no data reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02658890 · results posted 28 August 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT02658890) enrolled a total of 696 participants across multiple groups, spread across three main parts of the study. The trial was testing a drug called BMS-986205 (given alone or in combination with nivolumab, and sometimes with other cancer medicines) across a wide range of cancer types, including melanoma, lung cancer, cervical cancer, bladder cancer, pancreatic cancer, and others. The trial was measuring things like unwanted health events (called adverse events), changes in blood test results (particularly relating to the liver and thyroid gland), and whether participants' tumours responded to treatment — for example, whether tumours shrank, stayed the same, or grew. The reported data shows that across the different treatment groups, varying numbers of participants experienced adverse events, serious adverse events, events that led to stopping treatment, and deaths. For example, in some of the dose-combination groups in Part 1, between 6 and 18 participants out of those enrolled experienced adverse events. Abnormal thyroid blood test results were recorded in small numbers of participants across groups — ranging from 1 to 7 participants depending on the group. Abnormal liver blood test results were also recorded, ranging from 1 to 7 participants per group. For tumour response in Parts 2 and 3, the reported data shows that complete or partial tumour responses (meaning tumours disappeared or shrank by at least 30%) were recorded in small numbers of participants in most groups — for instance, the melanoma group that had not previously received immunotherapy reported 15 participants with a best overall response, while several other groups reported 0 to 3 responses. Some outcome figures were not fully reported in the available data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03581188 · results posted 1 August 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03581188) enrolled 100 people who had previously been treated for melanoma skin cancer — 49 in a **patient-led surveillance** group and 51 in a **clinician-led surveillance** group. The study was exploring a model where patients monitor their own skin (using tools like a dermoscopy device and telehealth image review) compared with the usual approach of regular check-ups led by a clinician. By the end of the study, 30 participants in the patient-led group and 36 in the clinician-led group had completed the trial; the remaining participants did not complete it, though reasons were not detailed in the reported data. The reported data shows that the main (primary) outcome the trial was designed to measure was how many eligible and contacted patients actually agreed to join the study — and the reported figure was 100 participants out of those who were eligible and contacted. For the secondary outcomes, the data shows counts of how participants in each group reported checking their own skin: for example, in the patient-led group 13 participants reported checking as frequently as guidelines recommend, compared with 16 in the clinician-led group, while 30 versus 28 reported checking their whole body thoroughly. In the patient-led group, 23 out of 49 participants successfully submitted skin images for review by a dermatologist via telehealth at least once. The reported data also shows that the patient-led group attended a median of 2 clinic visits over the study period, compared with 1 visit in the clinician-led group. For skin lesions (spots) surgically removed, the reported median was 1 in the patient-led group and 0 in the clinician-led group, though what this difference means clinically was not described in the submitted data. It is worth noting that some detail behind these numbers — such as the full breakdown of skin self-examination categories or the reasons participants did not complete the trial — was not fully explained in the structured data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04099251 · results posted 27 July 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04099251) enrolled 790 people in total — 526 in the nivolumab group and 264 in the placebo group — though two people in the nivolumab group did not proceed past the pre-treatment stage. The trial was measuring several things related to melanoma that had been surgically removed, including how long people went without their cancer coming back (called recurrence-free survival), how long they went without the cancer spreading to distant parts of the body, and what happened during any subsequent treatment they needed. A smaller optional open-label phase (where everyone received nivolumab) also took place, involving 2 people from the nivolumab group and 30 from the placebo group. The reported data shows that for the two main outcomes — recurrence-free survival and distant metastasis-free survival, as well as progression-free survival through next-line therapy — the figures were listed as "NA" (not available), meaning those specific numbers were not reported in the submitted data. For one secondary outcome that was reported with numbers, the data shows that among people who went on to receive a further treatment after the trial, those in the nivolumab group stayed on that next treatment for an average of about 4.2 months, while those in the placebo group stayed on it for about 11.1 months. Regarding unintended medical events (called adverse events) that were tracked during the trial, the reported data shows that 502 out of 524 nivolumab participants and 229 out of 264 placebo participants experienced at least one adverse event of any kind. Of those, 115 nivolumab participants and 32 placebo participants experienced what were classified as more serious adverse events. Additionally, 91 people in the nivolumab group and 9 people in the placebo group stopped their treatment due to an adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02967692 · results posted 24 July 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT02967692) enrolled a total of 568 participants across four groups. It tested a combination of three medicines — spartalizumab (PDR001), dabrafenib, and trametinib — against dabrafenib and trametinib alone (with a placebo standing in for spartalizumab). The trial ran in three parts: a small safety check (Part 1, 9 people), a biomarker study to look at changes inside tumour and blood samples (Part 2, 27 people), and a larger randomised comparison (Part 3, 267 people in the combination arm and 265 in the placebo arm). No participants were recorded as having formally "completed" the study, meaning all had left the trial before the study closed — most commonly because the study ended or their condition changed. The reported data shows the following results across the trial's parts. In Part 1, 1 out of 9 participants experienced what the trial defined as a dose-limiting toxicity (a significant side effect occurring within the first 8 weeks). In Part 2, changes in two biological markers were recorded: a protein on tumour cells called PD-L1 showed a reported change of 1.7 to 2.7 percentage points from the starting level, and a type of immune cell in the blood (CD8+ cells) showed a reported change of 0.4 to 1.2 percentage points. In the main randomised comparison (Part 3), the reported median time before a participant's disease progressed or they died — known as progression-free survival — was 16.2 months in the spartalizumab combination group and 12.0 months in the placebo group. For overall survival (time from the start of the study until death from any cause), the reported median figures were 61.5 months in the combination arm and 41.6 months in the placebo arm. The proportion of participants whose tumours shrank or disappeared (overall response rate) was reported as 68.5% in the combination arm and 64.2% in the placebo arm. Overall survival data for Part 1 was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03911869 · results posted 31 May 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03911869) enrolled a total of 13 participants across two stages. Ten people took part in an initial "safety lead-in" phase, where they received a combination of two medicines — encorafenib (300 mg twice daily) and binimetinib (45 mg twice daily). A further three participants then entered the Phase 2 portion of the trial, receiving encorafenib at a standard dose (450 mg once daily) plus binimetinib (45 mg twice daily). No participants were enrolled into the planned high-dose Phase 2 arm. The trial was primarily measuring whether the drug combination caused any serious or limiting side effects at the doses tested, by tracking things like abnormal blood test results, changes in vital signs (such as blood pressure and heart rate), and other unwanted medical events. The reported data shows that, among the 10 participants in the safety lead-in phase, 3 experienced what the trial defined as a "dose-limiting toxicity" — meaning a side effect severe enough to prevent them from tolerating at least 75% of their planned doses during the first treatment cycle. When looking at all unwanted medical events (called treatment-emergent adverse events) by severity level, the reported data shows: 1 participant had Grade 1 (mild) events, 3 had Grade 2 (moderate), 5 had Grade 3 (severe but not immediately life-threatening), 1 had Grade 4 (life-threatening), and none had Grade 5 (fatal). The reported data also shows various abnormalities recorded in blood tests tracking liver function, blood cell counts, and other body chemistry markers, with numbers of affected participants varying across different measurements. Notable changes in vital signs — such as blood pressure and pulse rate — were also recorded in small numbers of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04410445 · results posted 21 April 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04410445) enrolled 765 people with melanoma — 378 in the group receiving a combination of two medicines called bempegaldesleukin (NKTR-214) and nivolumab, and 387 in the group receiving nivolumab alone. The trial was primarily measuring how long people went without their cancer coming back or spreading (called "recurrence-free survival"), and also tracked overall survival, how far the cancer spread, side effects experienced during treatment, and quality of life. The reported data shows that no numerical results were submitted for the primary outcome (recurrence-free survival) or for overall survival and distant metastasis-free survival — these figures were listed as "NA," meaning the data was not reported for those measures. Regarding side effects that appeared or worsened during treatment, the reported data shows that 370 out of 378 participants in the combination group and 330 out of 387 in the nivolumab-alone group experienced at least one such event. More detailed breakdowns were also reported, including 74 versus 33 participants experiencing a particular category of side effects, and 120 versus 50 in another category; one participant in the combination group and zero in the nivolumab-alone group were recorded in a further category. For quality of life, participants in both groups scored around 79 out of 100 for general health and quality of life at the start, with small decreases of around 3.7 points (combination group) and 1.5 points (nivolumab-alone group) recorded at approximately six months. Physical functioning scores started at around 91–92 out of 100 in both groups, with small decreases of about 2.4 and 1.9 points respectively at six months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04730349 · results posted 24 March 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04730349) enrolled 15 participants in total across two groups, both of which received a combination of two drugs — bempegaldesleukin and nivolumab. One group (8 people) received nivolumab at a weight-based dose of 4.5 mg/kg, while the other group (7 people) received nivolumab at a flat dose of 360 mg; both groups received the same dose of bempegaldesleukin. The trial was focused on measuring unwanted medical events (called adverse events) that occurred during and after treatment, including whether any events were severe enough to be considered "dose-limiting" — meaning serious enough that the dose could not be safely continued. The reported data shows that in both groups, zero participants experienced a dose-limiting toxicity during the first 42 days of treatment. However, all 15 participants across both groups experienced at least one adverse event (an unwanted medical occurrence during the study period). The reported data also shows that 6 out of 8 participants in the first group and 5 out of 7 in the second group experienced a serious adverse event — meaning one considered life-threatening, requiring hospitalisation, or causing significant disability. Drug-related adverse events were reported in 6 participants in each group. Events serious enough to lead to stopping treatment altogether were reported in 2 participants in the first group and 3 in the second. Deaths during the study were reported for 2 participants in the first group and 0 in the second group, though the data does not specify the cause of those deaths. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03635983 · results posted 19 December 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03635983) enrolled 783 people with cancer who were randomly assigned to one of two groups: 391 people received a combination of two medicines — bempegaldesleukin plus nivolumab — and 392 people received nivolumab on its own. The trial was measuring several things: how many people's tumours shrank or disappeared (called the objective response rate), how long people lived without their disease getting worse (progression-free survival), and how long people lived overall (overall survival). The reported data shows that, for tumour shrinkage or disappearance, 27.7% of people in the combination group had a confirmed response, compared with 36.0% in the nivolumab-alone group. For how long people lived without their disease worsening, the reported median figure (meaning the midpoint — half of participants lasted longer, half shorter) was 4.17 months in the combination group and 4.99 months in the nivolumab-alone group. For overall survival, the reported median was 29.67 months in the combination group and 28.88 months in the nivolumab-alone group. On the secondary measures, the reported data shows that 56.1% of the combination group and 58.5% of the nivolumab-alone group had their disease either shrink or stay stable. Among those who did respond, the reported median time until their response was first recorded was approximately 2.17 months in the combination group and 2.20 months in the nivolumab-alone group. The duration of response figure for the nivolumab-alone group was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01807182 · results posted 10 November 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people, all of whom received the same treatment — a combination of tumour-infiltrating lymphocytes (TIL, which are immune cells taken from a person's own tumour and grown in large numbers in a lab), chemotherapy, and a drug called aldesleukin (which helps immune cells grow). Seven of the 10 participants completed the trial, and three did not. The trial was measuring how participants' tumours responded to this treatment, how long the infused immune cells could be detected in the body, and what side effects were recorded. The reported data shows that, out of 10 participants, when looking at the best tumour response each person achieved: 2 had a complete response (all detectable tumour gone), 2 had a partial response (tumour shrank by 30% or more), 2 had stable disease (tumour neither shrank enough to count as a response nor grew enough to count as progression), and 4 had progressive disease (tumour continued to grow). For the secondary outcomes, the reported data shows that 1 participant had the infused immune cells detectable in their blood at each of three time points checked. All 10 participants were recorded as having experienced adverse events (side effects), graded using a standard medical scale — though the breakdown of those events is not detailed in the data provided here. Regarding biological markers measured in the blood, the reported data shows 2 participants had elevated levels of one marker (CXCL13+ CD4 cells), 3 had elevated levels of another (CXCL13+ CD8+ cells), and 6 had elevated levels of a third (regulatory cells). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04068181 · results posted 9 September 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT04068181) enrolled 72 people in total across four groups, all of whom had a type of breast cancer that had previously been treated with immunotherapy. The four groups were based on how and when the cancer had responded — or stopped responding — to prior treatment. Most participants received both study treatments: talimogene laherparepvec (an injected virus-based therapy) and pembrolizumab (an immunotherapy drug). The trial's main goal was to measure the "objective response rate" — that is, the percentage of participants whose tumours shrank by a meaningful amount or disappeared entirely during treatment. The reported data shows that, for the two groups whose cancer had come back or spread (Cohorts 1 and 2), the objective response rate was very low — around 3.8% and 6.7% respectively (roughly 1 in 26 and 1 in 15 participants). For the two groups in an "adjuvant" setting — meaning they were being treated to try to prevent recurrence after surgery — the reported response rates were higher: 40% for those whose cancer returned within six months (Cohort 3) and 46.7% for those whose cancer returned after six months or more (Cohort 4). When looking at complete disappearance of all detectable cancer (complete response rate), the reported data shows 0% in Cohorts 1 and 2, and 20% in both Cohorts 3 and 4. For responses lasting six months or longer, the reported figures were 3.8%, 6.7%, 40%, and 26.7% across the four groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04434560 · results posted 26 July 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT04434560) was designed to compare two groups of people: one receiving standard of care (no immunotherapy before surgery) and one receiving neoadjuvant immunotherapy — meaning immunotherapy given before an operation. The trial aimed to measure two main things: whether the immunotherapy caused surgery to be delayed by more than four days or prevented surgery from happening at all, and whether it changed the activity of certain immune cells in the blood (specifically a protein called Ki-67, which is a marker used to indicate how much cells are multiplying). According to the results reported on ClinicalTrials.gov, only one participant was enrolled in the standard of care group and none were enrolled in the immunotherapy group. The reported data shows that because only one person started the trial and no one was enrolled in the immunotherapy group, no measurements were recorded for either of the two primary outcomes. The results fields for both outcome measures are empty — no numbers were submitted. Given the very limited enrolment, the trial does not appear to have generated usable results data on either outcome measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02089685 · results posted 18 May 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT02089685) enrolled a total of 295 participants across six treatment groups. All groups received the immunotherapy drug pembrolizumab combined with either ipilimumab (IPI) or pegylated interferon alfa-2b (PEG-IFN), at varying doses. The trial was structured in parts (1A, 1B, and 1C) and was measuring things like how often participants experienced side effects, how often side effects led to stopping treatment, and — in the later parts of the trial — how often tumours shrank or disappeared in response to treatment. The reported data shows that across all groups, between 99.3% and 100% of participants experienced at least one adverse event (an unexpected medical occurrence during the study). The proportion of participants who stopped treatment because of an adverse event ranged from around 19.6% to 66.7% depending on the group. For the Part 1A dose-finding phase, the percentage of participants who experienced what are called "dose-limiting toxicities" (side effects serious enough to cap the dose) ranged from 0% to 66.7% across the subgroups studied, though figures for some subgroups were not reported in the data. In Parts 1B and 1C, between 45.1% and 60.8% of participants experienced pre-specified events of special interest (a defined list including immune-related reactions). For Part 1C specifically, 27.5% and 43.1% of participants in the two IPI dose groups experienced serious drug-related adverse events graded 3–5 (meaning they were considered moderate-to-severe or worse). On the tumour response measure in Part 1C, the reported data shows that 69.6% of participants in the IPI 50 mg group and 76.7% in the IPI 100 mg group had their tumours recorded as having shrunk or disappeared according to standard measurement criteria. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02263508 · results posted 16 May 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT02263508) involved two stages. The first stage (Phase 1b) enrolled 21 participants who all received a combination of two treatments: talimogene laherparepvec (an injectable medicine) and pembrolizumab (an immunotherapy medicine). The second stage (Phase 3) enrolled 692 participants, split into two equal groups of 346 — one group received pembrolizumab plus a placebo (an inactive substitute), and the other received pembrolizumab plus talimogene laherparepvec. The trial was measuring things like how long participants went without their cancer growing (called progression-free survival), how long participants lived overall, and whether certain side effects occurred early on. The reported data shows that in Phase 1b, none of the 21 participants experienced what the trial defined as a "dose-limiting toxicity" — that is, a serious side effect severe enough to limit the dose. Around 62% of Phase 1b participants had their tumours shrink or disappear (a complete or partial response), and about 57% maintained that response for at least six months. In Phase 3, the reported median progression-free survival — meaning the midpoint time before cancer grew or participants died — was 14.3 months in the talimogene laherparepvec plus pembrolizumab group, compared with 8.5 months in the placebo plus pembrolizumab group. For overall survival (how long participants lived), the data was not reported as a final number for either group, meaning a definitive median figure was not available at the time of reporting. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03679767 · results posted 10 May 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03679767) enrolled 121 participants across four cancer types: 35 with melanoma (skin cancer), 23 with non-small cell lung cancer, 29 with urothelial carcinoma (a cancer of the urinary tract), and 34 with renal cell carcinoma (kidney cancer). The trial was measuring how participants' tumours responded to the study treatment (retifanlimab), and tracked things like how long any response lasted, how long before the disease worsened, and how long participants lived overall. It is noted in the data that none of the participants were recorded as having formally "completed" the study. The reported data shows that the main thing being measured — the percentage of participants whose tumours shrank by a meaningful amount or disappeared entirely — was 40.0% in the melanoma group, 34.8% in the lung cancer group, 37.9% in the urothelial carcinoma group, and 23.5% in the renal cell carcinoma group. When stable disease (tumours neither growing nor shrinking significantly) was also counted, the reported figures were 54.3%, 65.2%, 55.2%, and 64.7% respectively across the four groups. For how long participants lived without their disease worsening, the reported figures ranged from 3.6 months (melanoma) to 5.7 months (urothelial carcinoma). Overall survival figures were reported for the lung cancer group (21.9 months) and urothelial carcinoma group (15.2 months), while the data was not reported for the melanoma and renal cell carcinoma groups. How long tumour responses lasted was reported for the lung cancer group (18.2 months) and urothelial carcinoma group (11.5 months), but was not reported for the other two groups. Regarding unwanted medical events that occurred during treatment, the reported data shows these were recorded in 32 of 35 melanoma participants, 21 of 23 lung cancer participants, 28 of 29 urothelial carcinoma participants, and 32 of 34 renal cell carcinoma participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01127451 · results posted 13 April 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 75 people in total — 43 in one group and 32 in another. Both groups received a drug called denileukin diftitox, but on different schedules: one group received it on days 1 through 4 of each treatment cycle, while the other received it on days 1, 8, and 15. The trial was primarily measuring how many participants' tumours shrank or disappeared by a meaningful amount, and also tracked how long people went without their cancer worsening, how long any response lasted, and how long participants survived overall. The reported data shows that for the main outcome — the proportion of participants whose tumours shrank or disappeared — 9.5% of people in the days 1–4 group and 3.1% in the days 1, 8, and 15 group met that threshold. For how long participants went without their cancer getting worse, the reported midpoint figure (known as the median) was 12.1 weeks in both groups. At the six-month mark, approximately 28.5% of the days 1–4 group and 23.0% of the days 1, 8, and 15 group had still not had their cancer worsen. Among those whose tumours did respond, the reported median duration of that response was around 32.9 weeks in the days 1–4 group and 54.3 weeks in the days 1, 8, and 15 group. The reported data shows that for overall survival, the median time was approximately 51.1 weeks in the days 1–4 group and 54.3 weeks in the days 1, 8, and 15 group. At the one-year mark, approximately 42.8% of participants in the days 1–4 group and 50.0% in the days 1, 8, and 15 group were reported as still alive. It is worth noting that the data shows zero participants were recorded as having "completed" the study in the usual sense, which the trial's own records reflect — this was not unusual for a trial of this type where participants continued until their disease progressed or they withdrew. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00145158 · results posted 7 April 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 23 people in total across two groups. Sixteen participants received a combination of eight protein fragments (peptides) together with an immune-stimulating substance called CpG 7909, while seven received the same peptides combined with a different substance called Montanide ISA51. The trial was primarily looking at whether the body's immune system produced a specific type of immune cell response — called a cytotoxic T-lymphocyte (CTL) response, meaning cells that can recognise and target specific markers — after receiving the vaccine combination. Secondary measurements included whether any tumours changed in size, whether serious side effects occurred, and whether the immune response was linked to the presence of certain genes in the tumour. The reported data shows that, for the main measurement, 6 out of 16 people in the CpG 7909 group produced a detectable immune cell response to at least one of the peptides, compared with 1 out of 7 in the Montanide ISA51 group. A separate but related figure in the data reports 8 participants in the first group and 2 in the second group — the trial record does not fully clarify what distinguishes these two sets of numbers. For tumour size changes, the reported data shows that no participants in either group had their tumours disappear completely or shrink by 30% or more. In the CpG 7909 group, 4 people had stable disease (tumours neither grew nor shrank enough to meet any other category), and 10 had progressive disease (tumours grew). In the Montanide group, 0 had stable disease and 4 had progressive disease. Regarding serious side effects meeting the trial's pre-defined threshold (called dose-limiting toxicities), 2 participants in the CpG 7909 group and 0 in the Montanide group were reported to have experienced these. The reported data also shows that 3 participants in the CpG 7909 group and 1 in the Montanide group had both a detectable immune cell response and evidence that their tumour carried the relevant genes — though what this means in practice was not elaborated on in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03470922 · results posted 29 March 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03470922) enrolled 714 people in total — 355 in one group who received a combination of two medicines called relatlimab and nivolumab, and 359 in a second group who received nivolumab alone. The trial was measuring how long participants went without their cancer growing or spreading (called "progression-free survival"), as well as overall survival and response rates. Of those who started, 237 and 227 participants respectively were recorded as having completed the study. The reported data shows that, for the primary measure of progression-free survival, participants in the combination group had a reported median time (the midpoint figure — meaning half of participants had longer and half had shorter times) of 10.12 months before their disease progressed or they died, compared with 4.63 months in the nivolumab-alone group. For the two other main measures — overall survival and overall response rate — no numerical results were reported in the submitted data, so those figures are not available here. The reported data also shows figures for unwanted medical events that occurred during the trial. In the combination group, 345 out of 355 participants experienced at least one adverse event (an unwanted medical occurrence during the study), compared with 339 out of 359 in the nivolumab-alone group. Serious adverse events were recorded for 121 participants in the combination group and 105 in the nivolumab-alone group. Adverse events that led to a participant stopping treatment altogether were reported for 69 people in the combination group and 41 in the nivolumab-alone group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01335009 · results posted 1 September 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 76 people with cancer across two groups: 40 people received a lower dose of an experimental drug called MORAb-004 (2 mg/kg) and 36 received a higher dose (4 mg/kg). The trial was primarily measuring how many participants were still alive and had not had their cancer grow or spread (called "progression-free survival") at 24 weeks after starting treatment. By the time the trial ended, only 9 people in the lower-dose group and 3 in the higher-dose group had completed the study, with the remainder leaving before the end for various reasons. The reported data shows that at the 24-week mark, 13.5% of participants in the lower-dose group and 8.9% in the higher-dose group were still alive without their cancer progressing. Looking at an earlier time point of 16 weeks, those figures were higher — 32.5% and 20.8% respectively. At 52 weeks, data for the lower-dose group was not reported, while 8.9% in the higher-dose group remained progression-free. For overall survival — how long participants lived from the start of the trial — the reported median was around 40.9 weeks in the lower-dose group and 29.3 weeks in the higher-dose group. A small overall response (meaning tumour shrinkage meeting a set definition) was reported in 3.1% of the higher-dose group, while that figure was not reported for the lower-dose group. The trial also aimed to identify an "optimal biologic dose," but the reported data shows this was not determined for either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02974803 · results posted 17 August 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants, all of whom were in a single group receiving a combination of two medicines called dabrafenib and trametinib. All 6 participants completed the study. The trial was set up to measure how well the treatment controlled cancer that had spread to the brain (called intracranial response), as well as cancer elsewhere in the body, how long any response lasted, and how long participants went without their cancer getting worse. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — including the primary measure (response of tumours inside the brain), nor any of the secondary measures such as response outside the brain, duration of response, or time without disease progression. In other words, while the trial ran and all participants finished, the actual figures for what was observed were not reported in the structured results data available on ClinicalTrials.gov. Because no measurement data was provided, it is not possible to describe what the trial found in terms of numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00910650 · results posted 4 August 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 14 people, all of whom received a treatment called F5 T-cell Receptor (TCR) Transgenic Cells — a type of modified immune cell therapy. Twelve participants completed the trial, while two did not finish. The trial was measuring two main things: first, how many participants reached the maximum time allowed in the study without their tumour growing back or getting worse; and second, how many participants were still alive by the end of the study period (overall survival). The reported data shows that when it came to the primary measure — reaching the end of the allowed study period without tumour return or progression — the number of participants who achieved this was reported as zero. For the secondary measure of overall survival, the reported data shows figures of 14 and 0 participants respectively, though the way these two numbers relate to each other (for example, whether they represent different time points or categories) is not fully explained in the structured data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02521870 · results posted 3 August 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02521870) involved a drug called SD-101, which was given by injection directly into tumours alongside another type of cancer treatment. The trial ran in two stages: a first stage (Phase 1) that tested four different doses of SD-101 in 22 people to find a safe dose range, and a second stage (Phase 2) that enrolled a further 219 people across several sub-groups — people with melanoma (a type of skin cancer) or head and neck cancer (known as HNSCC), who had either previously received or never received a type of immunotherapy drug called an anti-PD-1/L1 treatment. The trial measured things like how many participants' tumours shrank or disappeared (called the "overall response rate"), how long those responses lasted, and how many participants' disease did not worsen (called "disease control"). The reported data shows that in Phase 1, no participants in any dose group experienced what the trial defined as a "dose-limiting toxicity" — that is, a serious side effect occurring in the first 29 days that would signal the dose was too high. For the overall response rate in Phase 2 and Phase 1 combined, the reported numbers of participants whose tumours responded varied considerably across groups: for example, 9 out of 25 melanoma participants who had not previously had immunotherapy and received the 2 mg dose showed a response, compared with 4 out of 16 in the equivalent 8 mg group; among those who had previously received immunotherapy, responses were lower (0 out of 7 for melanoma at 2 mg, and 1 out of 3 at 8 mg). For head and neck cancer, 2 out of 13 participants who had not previously had immunotherapy responded at the 2 mg dose, and 0 out of 11 at the 8 mg dose. The reported data shows that among those who did respond, the time until a response was first recorded ranged from roughly 2 to 5 months across groups, and how long responses lasted ranged from about 2 to nearly 12 months. The disease control figures (meaning tumour shrank, disappeared, or at least stayed stable) were higher than response-only numbers across all groups, with the largest group — melanoma participants new to immunotherapy at 2 mg — reporting disease control in 36 out of 54 participants for whom data was available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03068455 · results posted 22 July 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03068455) enrolled 920 people in the combination arm (nivolumab plus ipilimumab, referred to here as Arm A) and 924 people in the single-drug arm (nivolumab alone, referred to as Arm B). The trial was measuring how long people with melanoma went without their cancer coming back or spreading — called "recurrence-free survival" — as well as how long people survived overall and how long it was before they needed further treatment. Participants were also grouped according to a protein marker on their tumour cells called PD-L1, which was used to see whether the results differed depending on the level of that marker. The reported data shows that for the main group of all participants combined, a median recurrence-free survival figure (the point at which half the group had experienced a recurrence or death) was not reached and is listed as "NA" (not available) for both arms — meaning the data had not matured enough at the time of reporting to calculate that figure. For the subgroup of participants whose tumours showed low levels of the PD-L1 marker (less than 1%), the reported median time without recurrence was approximately 33 months in Arm A (combination) and approximately 28 months in Arm B (single drug). For overall survival — how long people lived — the median figure was not reached and is listed as "NA" for both arms across all participant groups. Similarly, the reported data for time to next treatment was also listed as not available for both arms. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01909453 · results posted 12 July 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT01909453) enrolled 921 participants across five treatment groups. The trial was testing different combinations and doses of two cancer medicines — LGX818 (also called binimetinib) and MEK162 (also called encorafenib) — compared to an existing medicine called vemurafenib, in people with a particular type of cancer. The trial was run in two parts. Part 1 compared the combination of LGX818 450 mg with MEK162 (called "Combo 450"), LGX818 300 mg alone, and vemurafenib, with 192, 194, and 191 participants respectively. Part 2 compared a combination of LGX818 300 mg with MEK162 (called "Combo 300") versus LGX818 300 mg alone, with 258 and 86 participants. The main thing being measured was "progression-free survival" — that is, how long, on average, participants went before their disease showed signs of worsening or they died. The reported data shows that in Part 1, the median progression-free survival (the point at which half the group had experienced disease worsening or death) was reported as 14.9 months for the Combo 450 group, compared to 7.3 months for the vemurafenib group and 9.6 months for the LGX818-alone group. For overall survival (how long participants lived from the start of the trial), the reported median figures were 33.6 months for Combo 450, 23.5 months for LGX818 alone, and 16.9 months for vemurafenib. In Part 2, the reported median progression-free survival was 12.9 months for the Combo 300 group and 7.4 months for the LGX818-alone group. The reported data also shows that adverse events (unwanted medical occurrences during the trial) were recorded in 98.4% of Combo 450 participants, 99.5% of the LGX818-alone group, and 100% of the vemurafenib group in Part 1. Serious adverse events were reported in 43.8%, 37.0%, and 41.9% of those groups respectively. Notable worsening in laboratory test results was also tracked and recorded across all groups, with varying numbers of participants affected in different categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03329846 · results posted 9 July 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03329846) enrolled 20 people in total — 10 in a group receiving a combination of two medicines (nivolumab plus BMS-986205) and 10 in a group receiving nivolumab alone. The trial was measuring how many participants experienced adverse events (unwanted health events that occurred during the study), including serious ones, events linked to the study drugs, and events that led someone to stop taking the treatment. Only a small number of participants — 2 in the combination group and 1 in the nivolumab-only group — completed the study, with the majority not completing it for reasons not detailed in the reported data. The reported data shows the following counts of adverse events across the two groups. No deaths were recorded in either group. Three participants in each group experienced any adverse event of any cause. One participant in the combination group experienced an adverse event considered related to the study drugs, compared to none in the nivolumab-only group. One participant in the combination group experienced a serious adverse event (a more significant health event requiring closer attention), compared to none in the nivolumab-only group. When it came to adverse events of any cause that were also serious, 10 out of 10 participants in the combination group and 9 out of 10 in the nivolumab-only group were reported to have experienced these. Nine participants in the combination group and 7 in the nivolumab-only group experienced non-serious adverse events linked to the study drugs that led to stopping treatment. It is worth noting that the data as submitted contains some figures that may appear inconsistent (for example, the totals for certain categories exceeding others), and the reporting format does not allow for a full explanation of these numbers here. The reported data should be interpreted carefully and in context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02388906 · results posted 15 June 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02388906) enrolled 453 participants in each of two groups — one group received a drug called nivolumab (at a dose of 3 mg/kg) and the other received a drug called ipilimumab (at a dose of 10 mg/kg). Both are treatments used in melanoma (skin cancer). The trial was primarily measuring "recurrence-free survival" — that is, how long participants went without their cancer coming back or dying. It also tracked how long participants lived overall, and recorded adverse events (unwanted health events that occurred during the trial). The reported data shows that, for the primary measure of recurrence-free survival, the nivolumab group had a median (midpoint) figure of approximately 52.4 months, while the ipilimumab group had a median of approximately 24.1 months. For overall survival — how long participants lived — the data was reported as "not available" for both groups, meaning those figures were not provided in the submitted results. Regarding adverse events, the reported data shows that 440 participants in the nivolumab group and 446 in the ipilimumab group experienced at least one adverse event of any kind. Serious adverse events were recorded in 80 nivolumab participants and 184 ipilimumab participants. Deaths during the trial period were recorded for 128 participants in the nivolumab group and 142 in the ipilimumab group. Laboratory abnormalities (unusual blood or test results) were also recorded across both groups, with various figures reported, though the full breakdown of those categories was not clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03064763 · results posted 14 June 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03064763) enrolled 18 participants, all of whom received the study treatment, talimogene laherparepvec (sometimes called T-VEC). Nine participants completed the trial and nine did not. The trial was measuring two main things: whether participants experienced serious side effects severe enough to limit the dose (called "dose-limiting toxicities"), and whether participants' tumours shrank and stayed smaller for at least six months within the first year of treatment (called the "durable response rate"). The reported data shows that none of the 18 participants experienced a dose-limiting toxicity as defined by the trial. For the durable response rate — meaning tumours that shrank significantly and stayed that way for at least six months — the reported figure was 11.1% of participants. The overall response rate (the proportion of participants whose tumours shrank at any point, whether or not that response lasted) was also reported as 11.1%. For two secondary measures — how long it took participants to first respond and how long any response lasted — the data was not reported as a calculable number. The reported data also shows that the median progression-free survival (the midpoint time before the disease worsened or a participant died) was approximately 3.07 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00118274 · results posted 20 April 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 170 people across four groups (Arms I through IV, with 41, 43, 42, and 44 participants respectively). The trial was testing peptide vaccines related to melanoma (a type of skin cancer), and it was looking at two main things: first, how many participants experienced serious side effects known as "dose-limiting toxicities" (side effects severe enough to limit the dose that could be given); and second, how many participants showed a particular immune system response — specifically, whether certain immune cells called CD8+ T cells reacted to melanoma-related proteins, as measured by a laboratory test called an ELISpot assay up to day 50 of the trial. The reported data shows that when it came to dose-limiting toxicities, 4 participants in Arm I, 7 in Arm II, 2 in Arm III, and 1 in Arm IV experienced these events. For the immune cell response measurement, the reported data shows that 32 participants in Arm I, 29 in Arm II, 8 in Arm III, and 12 in Arm IV recorded a measurable CD8+ T cell response to the melanoma proteins by day 50. It is worth noting that not everyone who started the trial completed it — across the four groups, between roughly half and two-thirds of participants finished the study, though the reasons for not completing were not reported in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00199901 · results posted 8 April 2021

According to the results reported on ClinicalTrials.gov, this trial involved 110 people in total — 56 in the group that received the NY-ESO-1 ISCOMATRIX® vaccine and 54 in the group that received the ISCOMATRIX® adjuvant alone (a comparison substance without the vaccine component). The trial was measuring whether participants remained alive and free of their cancer returning over time, as well as tracking side effects and the body's antibody response (the presence of certain proteins the immune system can produce). The reported data shows that for the main measure — how many people were still alive and had not had their cancer return at 18 months — 29 out of the vaccine group and 28 out of the comparison group met this milestone, while 27 from the vaccine group and 26 from the comparison group had either relapsed or died within that time. Looking at the longer follow-up period of up to six years, 23 people in the vaccine group and 25 in the comparison group remained relapse-free, while 33 and 29 respectively had relapsed or died. For overall survival over the full observation period, 32 people in the vaccine group and 31 in the comparison group were recorded as surviving, while 24 and 23 respectively had died. Regarding side effects that emerged during treatment, 54 participants in the vaccine group and 52 in the comparison group experienced at least one such event, with smaller numbers in each group reporting more serious events — the data was not reported in a way that allows a full breakdown to be described here. The reported data also shows that antibody responses to NY-ESO-1 — a marker of how the immune system was reacting — appeared to differ between the two groups over time, with the vaccine group showing higher antibody response levels at day 71 compared to the comparison group, though the figures at other time points varied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01763164 · results posted 22 March 2021

According to the results reported on ClinicalTrials.gov, this trial compared two treatments for a form of cancer — binimetinib (also called MEK162) and dacarbazine (a chemotherapy). A total of 269 people were assigned to the binimetinib group and 133 to the dacarbazine group. The trial's main goal was to measure "progression-free survival" — that is, how long people went before their disease got worse or they passed away. It also tracked a number of secondary measures, including how long people lived overall, how many people's tumours shrank, and how long any shrinkage lasted. The reported data shows that, for the primary measure, the median time before disease progression or death was 2.83 months in the binimetinib group and 1.51 months in the dacarbazine group. For overall survival (how long people lived in total), the reported median figures were 10.97 months for binimetinib and 10.09 months for dacarbazine. When it came to tumour response, the reported data shows that approximately 15.2% of people in the binimetinib group had confirmed tumour shrinkage, compared with 6.8% in the dacarbazine group; when unconfirmed responses were also included, those figures were 22.7% and 9.8% respectively. Among those whose tumours did shrink, the median time before the response first occurred was 1.45 months in the binimetinib group and 2.79 months in the dacarbazine group, and how long that response lasted was reported as a median of 6.87 months for binimetinib (the corresponding figure for dacarbazine was not reported). The "disease control rate" — the percentage of people whose disease either shrank or remained stable — was reported as 58.4% for binimetinib and 24.8% for dacarbazine. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00130442 · results posted 22 January 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 134 people with melanoma — 66 in the group receiving PI-88 combined with a chemotherapy drug called dacarbazine, and 68 in the group receiving dacarbazine alone. The trial was mainly measuring how many participants in each group had their disease either respond to treatment or remain stable (not get worse) after six rounds of treatment. It also tracked similar measures at earlier points in treatment, how long it took for the disease to progress, how long any response lasted, and how long participants survived. The reported data shows that for the main measure — disease not progressing after six treatment cycles — 13 out of 66 participants were counted as non-progressors in the PI-88 plus dacarbazine group, compared with 18 out of 68 in the dacarbazine-alone group. For secondary measures at earlier time points (after two or four cycles), the reported numbers of non-progressors were broadly similar between the two groups. The reported data shows a median time until disease progression of 66 days in the combination group and 82 days in the dacarbazine-alone group. The duration of any response was reported as approximately 117 days in the combination group and 141 days in the dacarbazine-alone group. Survival time was reported as 304 days in the combination group and 416 days in the dacarbazine-alone group. ("Median" here simply means the midpoint figure — half the participants fell above it and half below.) These figures are what was recorded and submitted by the trial sponsors, and the reported data shows differences in numbers between the two groups across all measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02908672 · results posted 19 November 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02908672) enrolled 514 people in total across two groups during an initial run-in period — 258 in one group and 256 in the other. After that phase, 461 participants moved into the main part of the trial, where they were randomly assigned to receive either a combination of two medicines (cobimetinib and vemurafenib) plus a placebo (an inactive dummy treatment), or those same two medicines plus a third active medicine called atezolizumab. The trial was primarily measuring how long participants went before their cancer showed signs of growing or spreading — a timeframe known as "progression-free survival." The reported data shows that, for the main outcome, the group receiving the placebo plus the two medicines had a median progression-free survival of 10.6 months, while the group receiving all three active medicines had a median of 15.1 months. (Median here simply means the point at which half the people in the group had experienced disease progression or death, and half had not yet.) A separate, independent review of scans gave similar figures: 12.3 months and 16.1 months respectively. For overall survival — the time from enrolment until death from any cause — the reported data shows a median of 25.8 months in the placebo group and 39.0 months in the three-medicine group. Around 65% of participants in the placebo group and 67% in the three-medicine group showed a measurable reduction in their cancer during the trial. Among those who did respond, the reported data shows the response lasted a median of 12.6 months in the placebo group and 21.0 months in the three-medicine group. At the two-year mark, approximately 53% of the placebo group and 62% of the three-medicine group were reported as still alive. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00142454 · results posted 22 October 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 9 participants, and all 9 completed the study — none dropped out. The trial involved a single group who received a combination of imiquimod (a cream applied to the skin) and a cancer vaccine called NY-ESO-1. The study was measuring two main things: what kinds of side effects or unwanted reactions participants experienced, and whether the treatment triggered certain responses from the immune system (the body's defence system). The reported data shows that when it came to side effects, 8 out of 9 participants experienced what the researchers called "treatment-emergent adverse events" — that is, unwanted reactions that appeared or got worse after the first dose. Of those 8, the reported data shows all 8 experienced mild-to-moderate reactions (graded as Grade 1 or 2), while none experienced severe (Grade 3) or life-threatening (Grade 4) reactions. For the immune system measurements, the reported data shows that 7 out of 9 participants showed a cellular immune response (a type of response involving specific immune cells called CD8+ and CD4+ cells) at two or more points during follow-up, while 0 out of 9 showed this type of cellular response from CD4+ cells specifically — though it is worth noting the data for these two sub-measures was reported separately and the breakdown between them was not fully detailed. Separately, 4 out of 9 participants showed a humoral response — meaning a detectable increase in antibody levels (proteins the immune system makes to recognise a specific target) confirmed to be specific to NY-ESO-1. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01781572 · results posted 12 August 2020

According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two experimental medicines — ribociclib (also called LEE011) and binimetinib (also called MEK162) — given together at various doses. The trial had two main stages: an early phase (Phase 1b) to find the right dose, and a later expansion phase (Phase 2) to look at how many patients' tumours responded to the chosen dose. In total, 82 people took part across three groups — 29 in the 28-day dosing schedule group, 32 in the 21-day dosing schedule group, and 41 in the dose-expansion group. No participants were recorded as having formally "completed" the trial, meaning all had left the study before its end, though the reasons for this are not detailed in the reported data. The reported data shows that in the early dose-finding phase, the researchers counted specific unwanted effects severe enough to be called "dose-limiting toxicities" (DLTs — that is, side effects serious enough within the first treatment cycle to affect what dose could be used). Across the ten different dose combinations tested, the number of DLTs reported ranged from zero to three. The highest number (3 DLTs) occurred in the group receiving MEK162 45mg plus LEE011 300mg on the 28-day schedule. For the Phase 2 expansion stage, the main thing measured was the "objective response rate" — the proportion of patients whose tumours shrank or disappeared to a meaningful degree based on scan measurements. The reported data shows that 8 out of 41 participants in the Phase 2 group met this measure. The trial also tracked how the two medicines moved through participants' bloodstreams at different doses; these figures were recorded across all dose groups, but interpreting those detailed numbers would require specialist knowledge beyond what is reported here in plain terms. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02889861 · results posted 27 July 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02889861) was a small "rollover" study — meaning participants had already been in an earlier related trial and continued into this one. Only 3 people took part, all receiving the same treatment regimen involving a drug called IMCgp100. One person completed the study and two did not. The trial was primarily measuring how often participants experienced treatment-emergent adverse events (that is, any unwanted medical occurrences that started or got worse after beginning the study drug), and also tracking details about how the treatment was given over time, such as interruptions and doses received. The reported data shows that 2 out of 3 participants experienced at least one treatment-emergent adverse event overall. Of those, 2 participants had events that the investigating doctor considered possibly or definitely related to the study drug. One participant had a serious adverse event. No data was reported for several other adverse event subcategories, as the values recorded were zero across those categories. Regarding how the treatment was delivered, the three participants started 2, 26, and 18 treatment cycles respectively (each cycle lasting 22 days), and completed 1, 25, and 17 of those cycles. The total amount of drug received by each participant was 350, 5,100, and 3,500 micrograms respectively. All three participants were reported as receiving 100% of their planned relative dose intensity — meaning each received the full proportion of drug that had been planned for the duration they were in the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03178851 · results posted 12 June 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 155 people across three groups: Cohort A (92 participants), Cohort B (11 participants), and Cohort C (52 participants). The trial was measuring how a treatment affected solid tumours, looking mainly at two things: the proportion of participants whose tumours shrank or disappeared (called the objective response rate, or ORR), and the proportion whose disease did not grow significantly for at least 16 weeks (called the disease control rate, or DCR). The reported data shows that none of the participants were recorded as having completed the study, though the data does not explain the reasons for this in detail. The reported data shows that for the primary measures, the percentage of participants whose tumours shrank or disappeared was 12.0% in Cohort A, 36.4% in Cohort B, and 38.5% in Cohort C. For disease control at 16 weeks, the reported figures were 37.0% in Cohort A, 54.5% in Cohort B, and 46.2% in Cohort C. For the secondary measures, the median length of time a response lasted (duration of response) was reported as 24.2 months in Cohort A, while this figure was not reported for Cohorts B and C. The median time participants survived overall was reported as 12.5 months for Cohort A, 22.0 months for Cohort C, and was not reported for Cohort B. The median time before the disease progressed or death occurred (progression-free survival) was 3.7 months for Cohort A, 9.3 months for Cohort B, and 3.7 months for Cohort C. Blood concentration levels of the study drug atezolizumab were also measured and reported across multiple time points, with various figures recorded for each cohort. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03273153 · results posted 9 June 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 446 people with cancer — 224 in a group receiving a medicine called pembrolizumab, and 222 in a group receiving a combination of two medicines called cobimetinib and atezolizumab. The trial was mainly measuring how long participants went without their disease getting worse (called "progression-free survival"), as assessed by an independent review panel. It also looked at a number of secondary measures, including how long people lived overall, how many participants' tumours shrank or disappeared, and how many had their disease kept under control. The reported data shows that, based on the independent review panel's assessment, the median time before disease worsening or death was 5.7 months for the pembrolizumab group and 5.5 months for the cobimetinib-and-atezolizumab group. ("Median" here simply means the middle value — half of participants reached that point sooner, half later.) When the treating doctors made their own assessments, the reported figures were 7.2 months and 5.6 months respectively. For tumour shrinkage or disappearance (known as "objective response"), the independent panel reported this occurred in 31.6% of participants in the pembrolizumab group and 26.0% in the combination group; the treating doctors' figures were 36.7% and 27.9%. For disease control at 16 weeks, the reported data shows figures of around 44–50% in the pembrolizumab group and around 46–47% in the combination group across the two sets of assessments. For overall survival, the median was reported as 29.3 months in the pembrolizumab group; the corresponding figure for the combination group was not reported in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01826448 · results posted 28 May 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 13 people in total — 4 in one group (Cohort 1) and 9 in another group (Cohort 2). Both groups received a combination of two medicines, PLX3397 and vemurafenib, but at slightly different doses of vemurafenib. The trial was looking at participants who had a type of skin cancer called melanoma with a specific gene change (V600 mutation in the BRAF gene). The main thing being measured was how many participants experienced adverse events — that is, unwanted or unexpected medical occurrences during the trial. No participants completed the study in either group, though the data does not explain the reasons for this. The reported data shows that 100% of participants in both groups experienced some form of adverse event. Beyond that overall figure, the data includes several further breakdowns of adverse event percentages. In Cohort 1 (the lower vemurafenib dose group), the reported figures across these additional categories were 100%, 100%, 75%, 25%, and 25% of participants. In Cohort 2 (the higher vemurafenib dose group), the corresponding figures were 100%, 55.6%, 77.8%, 77.8%, and 44.4%. The specific categories these individual percentages refer to were not labelled in the data provided, so a detailed breakdown cannot be described here. It is worth noting that with only 13 participants across both groups, this was a very small trial, and no secondary outcome measures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02211131 · results posted 28 May 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02211131) enrolled 150 people with melanoma — 74 in the surgery-only group and 76 in the group that received talimogene laherparepvec (an injectable treatment) before surgery. The trial was primarily measuring "recurrence-free survival," which means the length of time after treatment before the cancer came back or a participant died from any cause. A number of secondary measures were also tracked, including the proportion of participants who had no cancer cells detectable at the edges of the removed tissue (called a "clear margin" or R0 resection), the proportion whose surgical sample showed no living tumour cells at all (called a pathological complete response), and how many participants remained recurrence-free at one, two, three, and five years. The reported data shows that for the primary outcome — recurrence-free survival — the median time recorded was 0.0 months in both groups, which the trial's own definition explains: participants who did not achieve a clear surgical margin or who withdrew before surgery were counted as having an event at the very start (day zero), which heavily influences this figure. For the secondary recurrence-free survival checkpoints, the reported data shows the following percentages of participants still recurrence-free at each time point: at one year, approximately 22% in the surgery-only group and 34% in the combination group; at two years, roughly 17% and 30%; at three years, approximately 17% and 28%; and at five years, about 15% and 22%. The reported rate of clear surgical margins (R0) was 37.8% for surgery alone and 42.1% for the combination group. For pathological complete response — no detectable living tumour cells in the removed tissue — the reported figures were 2.7% in the surgery-only group and 17.1% in the combination group. The local recurrence-free survival median was also reported as 0.0 months in both groups, for the same counting reasons noted above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02156804 · results posted 20 February 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,009 people who received the drug nivolumab (at a dose of 3 mg per kilogram of body weight). One person did not complete the study. The trial was primarily focused on tracking certain unwanted side effects — specifically serious ones (graded 3 or higher on a standard medical scale, meaning severe or worse) that were considered related to the treatment. These side effects were grouped into six body-system categories: lungs, digestive system, skin, kidneys, liver, and hormonal (endocrine) system. The reported data shows that, for the primary measure — serious side effects considered directly linked to treatment — the numbers across the six body-system categories were: 16 participants (lung-related), 0 (digestive), 30 (skin), 0 (kidney), 4 (renal — note this figure appears separately in the data), 13 (liver), and 1 (endocrine), though some sub-category breakdowns recorded zero. For a broader secondary measure that counted serious side effects from those same categories regardless of whether they were linked to treatment, the reported numbers were somewhat higher across the same groupings. The reported data also shows that the median time for these serious side effects to first appear ranged from approximately 10 to 34 weeks depending on the body system affected, and the median time for them to resolve ranged from roughly 0.3 to about 9.4 weeks. For overall survival — how long participants lived from their first dose — the reported median figure was 21.2 months, meaning half of participants lived longer than this and half did not. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02659540 · results posted 2 January 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people in total — 10 in a group receiving conventional radiotherapy (Cohort A) and 10 in a group receiving a shorter, higher-dose-per-session radiotherapy schedule known as hypofractionated radiotherapy (Cohort B). Both groups also received a study drug alongside their radiotherapy. The trial was primarily measuring how many participants experienced unwanted medical events (called adverse events) after starting treatment, and it also tracked how tumours responded at certain time points using standard imaging-based measurement tools. The reported data shows that all 10 participants in each group — that is, 20 out of 20 people — experienced at least one treatment-emergent adverse event (meaning a medical event that appeared or got worse after treatment began). When it came to tumour response at Week 12, using the standard RECIST 1.1 measurement system: in Cohort A, 4 participants showed complete disappearance of target tumour areas, 1 showed a meaningful shrinkage, and 5 showed stable disease (no major change); in Cohort B, 0 showed complete disappearance, 3 showed meaningful shrinkage, 6 showed stable disease, and 1 showed signs of tumour growth. Similar patterns were reported at Week 18. The reported data shows that duration of response figures were not reported in the submitted data. It is also worth noting that a number of participants did not complete the study — 6 out of 10 in Cohort A and 8 out of 10 in Cohort B did not finish, though the reasons were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02014116 · results posted 27 December 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 51 people in total across nine separate groups (called cohorts), with between 1 and 16 participants in each group. All 51 people received at least one dose of the study drug, LY3009120, a medicine being tested in people with advanced or spreading cancer. The trial was designed to find the highest dose of LY3009120 that could be given without causing unacceptable side effects (called the Maximum Tolerated Dose), and to take measurements of how the drug moved through the body. Notably, the reported data shows that zero participants across all groups were recorded as having formally "completed" the study. The reported data shows that the Maximum Tolerated Dose identified in Part A of the trial was 300 milligrams. When it came to tumour responses — meaning measurable changes in tumour size — across the three expansion cohorts (Cohorts A, B, and C), no participants were recorded as having a complete response (tumour disappearing entirely) and no participants had a partial response (tumour shrinking by at least 30%). Stable disease (where the tumour neither shrank enough to count as a response nor grew enough to count as worsening) was reported in 5 participants in Cohort C and none in Cohorts A or B. Disease progression was reported in 1 participant in Cohort A, 4 in Cohort B, and 1 in Cohort C. The reported data also included measurements of how much of the drug was present in the blood at various time points and doses; for example, on the first day of the study, the peak drug level in the blood ranged from approximately 105 nanograms per millilitre at the 50 mg dose up to approximately 1,718 nanograms per millilitre at the 500 mg dose. Data for the 500 mg group at later time points was not reported for some measurements. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02308020 · results posted 19 December 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02308020) looked at a drug called abemaciclib in people who had cancer that had spread to the brain — known as brain metastases. The trial was divided into several groups based on cancer type: hormone receptor-positive, HER2-positive breast cancer (Part A, 27 people); hormone receptor-positive, HER2-negative breast cancer (Part B, 58 people); a surgical group (Part C, 9 people); non-small cell lung cancer (Part D, 28 people); melanoma (Part E, 23 people); and a mixed group (Part F, 17 people). In total, 162 people were enrolled and all received at least one dose of the study drug. The main thing being measured was whether tumours in the brain shrank or disappeared — called the objective intracranial response rate. The reported data shows that for the primary outcome — the percentage of participants whose brain tumours completely disappeared or shrank by at least 30% — the results were: 0% in the HER2-positive breast cancer group (Part A), 5.8% in the HER2-negative breast cancer group (Part B), 0% in the lung cancer group (Part D), and 0% in the melanoma group (Part E). For secondary outcomes, the reported data shows that the proportion of participants whose disease was recorded as either responding or staying stable ("disease control") was 52.2% (Part A), 71.2% (Part B), 43.5% (Part D), and 31.8% (Part E). Among the small number of participants in Part B who did show a response, the reported duration of that response was 8.8 months on average. Overall survival — meaning the midpoint time from the start of the study until death from any cause — was reported as approximately 10.1 months (Part A), 13.4 months (Part B), 7.1 months (Part D), and 2.9 months (Part E). Data on duration of response was not reported for Parts A, D, or E. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01502293 · results posted 26 September 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01502293) looked at a treatment called Tavo-EP in people with skin tumours. A total of 51 people were enrolled across three groups: 30 in the main study group, 17 in an addendum group following one treatment schedule (Regimen A), and 4 in another addendum group following a different schedule (Regimen B). The trial's main goal was to measure the "objective response rate" — that is, the percentage of participants whose tumour lesions either disappeared completely or shrank by at least 30% during treatment. The reported data shows that in the main study group, 32.1% of participants met that response threshold. In both addendum groups (Regimen A and Regimen B), the figure was 25.0% in each. Using a different measurement method (called immune-related response criteria, which uses slightly different rules for what counts as a response), the reported rates were 28.6% for the main group, 25.0% for Regimen A, and 0% for Regimen B. Among those who did respond, the reported data shows the response lasted a median of 96 days in the main group and 127 days in Regimen A; no figure was reported for Regimen B. For overall survival — how long participants lived from the start of treatment — the data was reported as "not available" for all three groups. Regarding adverse events (any unwanted medical occurrence during the study), the reported data shows that 96.7% of the main study group and 94.1% of Regimen A experienced at least one adverse event, compared with 50.0% in Regimen B. Serious adverse events (those involving hospitalisation, risk of death, or significant disability) were reported in 6.7% of the main group, 17.6% of Regimen A, and 0% of Regimen B. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02302339 · results posted 6 September 2019

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called glembatumumab vedotin, given either on its own or in combination with one of three other treatments, in people with advanced melanoma (a type of skin cancer). In total, 132 people were enrolled across four groups: 62 received glembatumumab vedotin alone, 34 received it combined with varlilumab, 29 received it combined with a type of drug known as a PD-1 checkpoint inhibitor (a medicine that interacts with the immune system), and 7 received it combined with CDX-301. The trial was primarily measuring how many participants had their tumours shrink or disappear (called an "objective response"), and also tracking how long any such response lasted, how long participants went without their disease getting worse, and how long participants survived overall. The reported data shows that, looking at the number of participants whose tumours shrank or disappeared: 7 out of 62 in the glembatumumab vedotin-alone group, 1 out of 34 in the varlilumab combination group, 4 out of 29 in the PD-1 checkpoint inhibitor combination group, and 0 out of 7 in the CDX-301 combination group met this measure. For how long those responses lasted (in months), the reported figures were 6.0 months for the alone group, 2.2 months for the varlilumab combination, and 6.2 months for the PD-1 combination; no figure was reported for the CDX-301 group. The reported data shows the time participants went without their disease getting worse was 4.4 months, 2.6 months, and 4.1 months for the first three groups respectively, with no figure reported for the CDX-301 group. Overall survival figures were reported for the alone group (8.8 months) and the varlilumab combination group (6.6 months), but were not reported for the remaining two groups. Results for the measure examining how a particular protein level in tumour tissue related to treatment activity were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03552549 · results posted 24 July 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT03552549) compared two treatments — PEG-Intron and INTRON A — in people with a particular condition. A total of 63 participants were enrolled in each group (126 people overall), and 62 in each group actually received treatment. However, the trial was ended early, with only 10 participants in the PEG-Intron group and 11 in the INTRON A group completing the study as originally planned. The trial was primarily measuring how long participants went without their disease getting worse (called "progression-free survival"), and also how long participants lived overall. The reported data shows that no numbers were recorded for the main outcome — progression-free survival — for either group. This means those results were not reported in the data submitted to ClinicalTrials.gov, likely because the trial ended early before enough information could be gathered. For the secondary outcome of overall survival (how long participants lived from the start of the trial), the reported data shows that a median figure — meaning the middle point where half of participants had passed away and half had not — was not able to be calculated for the PEG-Intron group, while for the INTRON A group a median overall survival of 23.72 months was reported. The trial's early termination means these results are based on incomplete data, and the overall survival figures were provided as an additional analysis requested by a medicines regulator (the US FDA) rather than as part of the original study plan. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00685750 · results posted 20 June 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 88 people in total across seven groups: six groups of melanoma patients and one group of people with non-small cell lung cancer. The numbers in each group ranged from 2 to 21 participants. The trial was measuring things like whether certain proteins (called tumour antigens — specifically MAGE-A3 and NY-ESO-1) were present in participants' tumours before and after standard cancer treatment, whether a particular pattern of gene activity (called a "gene signature") could be detected in tumour samples, and how melanoma patients responded to a treatment called ipilimumab. The reported data shows that, for tumour antigen expression, the numbers of participants found to have MAGE-A3 varied across the six melanoma groups: 8, 0, 11, 1, 5, and 6 participants respectively, with 1 participant in the lung cancer group. For a second antigen (NY-ESO-1), figures were reported for five of the melanoma groups: 7, 0, 0, 0, and 5 participants. For the gene signature measure, the reported data shows varying numbers of participants testing positive both before and after treatment across the melanoma groups. Regarding clinical response to ipilimumab among melanoma patients grouped by their gene signature status, the reported data shows that among those with a positive gene signature, 9 experienced disease progression, 3 had stable disease, 1 had a partial response, and none had a complete response; among those with a negative gene signature, 4 experienced disease progression and 4 had stable disease; and among those with an invalid gene signature result, 1 had stable disease. Several other planned measurements — including the serum proteome analysis, a comparison of two laboratory testing methods, and a comparison of tumour samples from different sites in the same lung cancer patient — had no numerical results reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02581930 · results posted 18 June 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 18 people, all of whom received the drug ibrutinib. The trial was looking at how a type of tumour responded to the treatment, using a standard measurement system called RECIST 1.1, which tracks whether tumours shrink, stay the same, or grow. Sixteen of the 18 participants completed the study, and two did not. The reported data shows that when it came to the primary (main) outcome — whether any participant's tumour showed a meaningful shrinkage (defined as either complete disappearance or at least a 30% reduction in size) — the number recorded was zero out of 18 participants. For the secondary (additional) outcomes, the reported data shows that the median time before the disease progressed or death occurred (called progression-free survival) was 1.3 months, and the median overall survival — meaning the midpoint of how long participants lived from the start of treatment — was 6 months. Three other planned measurements, including an analysis of certain proteins in tumour tissue, changes in immune cells in the blood, and how the body processed the drug, were listed in the trial record but no results data was reported for those outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02153905 · results posted 5 June 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 3 participants across two groups. One person received a higher dose of specially engineered immune cells (called Anti-MAGE-A3 A1 TCR cells) combined with a hormone called Interleukin-2 (IL-2), and two people received a lower dose of the same combination. The trial was primarily measuring the highest dose that could be given without too many serious side effects, whether participants' tumours shrank, and what kinds of adverse events (unwanted medical occurrences) were recorded. A secondary goal was to track how long the engineered cells survived in the body after infusion, though no data for that measure was reported. The reported data shows that, when it came to tumour response, zero out of 1 participant in the higher-dose group and zero out of 2 participants in the lower-dose group showed a complete response (all tumours disappearing). One participant in the lower-dose group was reported to have a partial response (tumours shrinking by at least 30%). Regarding serious unwanted events, all 3 participants — 1 in the higher-dose group and 2 in the lower-dose group — were reported to have experienced at least one serious or non-serious adverse event. In the higher-dose group, 1 participant was reported to have experienced a dose-limiting toxicity (a serious side effect serious enough to affect how the dose could be increased), while no dose-limiting toxicities were reported in the lower-dose group. The data notes that the highest tolerated dose was not formally determined and reported a figure for this measure. No data on how long the engineered cells survived in the body was reported. It is worth noting that with only 3 participants total, this was a very small, early-stage trial, and the numbers above reflect only the individuals who took part. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00706238 · results posted 3 June 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT00706238) enrolled 5 participants, all of whom received a treatment called GSK1203486A — described as an "antigen-specific cancer immunotherapeutic," meaning a type of treatment designed to prompt the body's immune system to recognise specific proteins associated with cancer. The trial was set up to measure certain unwanted health events (called adverse events) that occurred during the study, as well as how participants' condition responded to the treatment. Notably, none of the 5 participants completed the trial. The reported data shows that, of the 5 participants, none experienced a severe or life-threatening treatment-related adverse event (graded 3 or 4 on a standard severity scale). However, 1 participant experienced what is classified as a "serious adverse event" — meaning a health occurrence serious enough to be life-threatening, require hospitalisation, or cause significant disability. Regarding the primary measure of how participants' condition responded to the treatment (called "objective clinical response rate"), no data was reported for this outcome. Similarly, the secondary outcome measures — including rates of stable disease, mixed response, and time until the treatment stopped working — also had no data reported, so those results are not available. It is worth noting that with only 5 participants and none completing the trial, the reported data is very limited. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02039947 · results posted 21 May 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 125 people in total, split across four groups (called cohorts): Cohort A had 76 participants, Cohort B had 16, Cohort C had 16, and Cohort D had 17. All participants who started the trial completed it — none dropped out, according to the reported data. The trial was measuring how tumours in the brain (intracranial) and outside the brain (extracranial) responded in participants across the four cohorts, as assessed by the investigators. The reported data shows that for the main (primary) outcome — the number of people in Cohort A whose brain tumours showed a confirmed response — 45 out of 76 participants met that measure. For the secondary outcomes, the number of participants showing a brain tumour response in Cohorts B, C, and D was 9, 7, and 10 respectively. When looking at tumour responses outside the brain, the reported numbers were 42 (Cohort A), 7 (Cohort B), 12 (Cohort C), and 7 (Cohort D). Overall tumour responses (brain and body combined) were recorded for 45, 9, 7, and 11 participants across Cohorts A through D. The trial also measured how long responses lasted (in months): for brain tumours, the reported figures were 6.5, 7.3, 8.3, and 4.5 months across the four cohorts; for tumours outside the brain, 10.2, not reported, 4.9, and 5.9 months; and for overall response, 6.2, 12.5, 6.6, and 4.5 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02752074 · results posted 15 May 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02752074) enrolled 706 people with cancer — 354 in a group receiving pembrolizumab combined with epacadostat, and 352 in a group receiving pembrolizumab combined with a placebo (an inactive substitute). The trial was primarily measuring two things: how long participants went without their disease getting worse (called "progression-free survival"), and the proportion of participants still alive at six months. The reported data shows that for progression-free survival — the time from joining the trial until the disease progressed or a participant died — the median (midpoint value for the group) was 4.7 months in the pembrolizumab-plus-epacadostat group and 4.9 months in the pembrolizumab-plus-placebo group. For the six-month survival rate, the reported figures were 84.1% in the epacadostat group and 87.2% in the placebo group. As a secondary measure, the number of participants whose tumours showed a recorded response (either shrinking or disappearing) was 121 out of 353 treated in the epacadostat group, and 111 out of 352 in the placebo group. Regarding how long those responses lasted, the data was not reported for either group. For reported side effects, the data shows adverse events were recorded in 346 participants in the epacadostat group and 345 in the placebo group, though the breakdown of specific events was not included in the submitted figures here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01835145 · results posted 26 April 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 47 people in total — 32 in one group who received a drug called cabozantinib-s-malate, and 15 in a comparison group who received either temozolomide or dacarbazine (two other medicines). Nearly all participants completed the study. The trial was looking at a type of cancer called uveal melanoma (a melanoma affecting the eye), and its main question was: what proportion of patients in each group had not experienced their cancer growing or spreading after four months of treatment? The reported data shows that, for the main question (known as "progression-free survival at four months"), roughly 32% of patients in the cabozantinib group and around 27% of patients in the comparison group had not experienced disease progression at that point. For a secondary measure — whether any patients had a confirmed shrinkage of their tumour according to standard criteria — the reported number was zero in both groups. The reported median time until disease progression was 2.0 months in the cabozantinib group and 1.9 months in the comparison group. The reported median overall survival (how long patients lived from the start of the trial) was 6.3 months in the cabozantinib group and 7.2 months in the comparison group. Regarding serious side effects (graded as "Grade 3 or higher," meaning significant or severe), the reported data shows these were experienced by approximately 51.6% of patients in the cabozantinib group and 20% of patients in the comparison group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02714218 · results posted 23 April 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02714218) enrolled 387 adults across three groups who received different dose combinations of two medicines — nivolumab and ipilimumab — given by intravenous drip (directly into a vein). The two main groups each had 180 participants: one received a higher dose of nivolumab paired with a lower dose of ipilimumab, and the other received the reverse. A smaller third group of 27 people received a different dose combination. The trial's primary focus was on measuring how many participants in the two main groups experienced serious side effects (graded 3 or above on a standard medical scale, meaning significant or severe) that were judged by the treating doctor to be related to the study medicines. The reported data shows that in the main nivolumab-higher-dose group, 32.8% of participants experienced at least one serious drug-related side effect, compared with 45.5% in the ipilimumab-higher-dose group. When additional data collected after the original cutoff date was included, those figures rose slightly to 33.9% and 48.3% respectively. For the secondary outcomes, the reported data shows that 47.8% of participants in the nivolumab-higher-dose group and 53.4% in the ipilimumab-higher-dose group had their tumour shrink or disappear during the trial period. The median time before the cancer grew or participants died (progression-free survival) was reported as approximately 10.2 months in the nivolumab-higher-dose group and approximately 10.0 months in the ipilimumab-higher-dose group. Overall survival figures were not reported in the submitted data. Small average declines in physical functioning scores on a quality-of-life questionnaire were also recorded across both groups at various time points, though the data was not reported in a way that allows a straightforward summary of each individual time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01838200 · results posted 28 March 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled a total of five people across two small groups. Three participants received a lower dose of BCG (a type of bacteria-based injection) and two received a higher dose. Both groups were also receiving ipilimumab, a cancer treatment drug. The trial was measuring side effects (called adverse events) from the treatment combination, as well as how participants' tumours responded over time. Notably, none of the five participants completed the study — all five left before it finished, though the reasons are not detailed in this summary. The reported data shows that when it came to side effects, all three participants in the lower-dose group and both participants in the higher-dose group experienced at least one treatment-related adverse event. In the lower-dose group, one person had a severe side effect meeting the trial's predefined "dose-limiting" threshold, while two others had moderate-level events. In the higher-dose group, one person had a dose-limiting event and one had a moderate-level event. For tumour response (measured using standard imaging criteria called RECIST), two participants in the lower-dose group and two in the higher-dose group had results that could be categorised — the specific breakdown across response categories (such as shrinkage or growth) is contained in the raw data but reflects very small numbers given only five people were enrolled. Using a separate immune-related response measure, small numbers of participants across both groups were recorded in various response categories. The reported data should be interpreted with great caution, as only five people took part in total, and none completed the study — meaning these numbers are very preliminary and limited in what they can tell us. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00796445 · results posted 19 March 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 895 people in the MAGE-A3 treatment group and 450 people in the placebo (dummy treatment) group — a total of 1,345 participants with melanoma skin cancer. The trial was measuring how long people went without their cancer coming back or dying (called "disease-free survival"), as well as broader survival and quality of life. Of those who started, 310 in the treatment group and 158 in the placebo group were recorded as having completed the study; the remainder did not complete it for various reasons, though the data does not detail all of those reasons. The reported data shows that for the main measure — disease-free survival — the rate of first events (cancer returning or death) per year of follow-up was 0.505 in the MAGE-A3 group and 0.478 in the placebo group in one analysis, and 0.366 versus 0.345 in a second analysis. For overall survival (deaths per person-year of follow-up), the reported figures were 0.177 for the MAGE-A3 group and 0.165 for the placebo group in one analysis, and 0.146 versus 0.140 in another. For spread of cancer to distant parts of the body, the reported rates were 0.387 (MAGE-A3) and 0.342 (placebo). The reported data also shows quality-of-life scores (on a scale where 1.0 means full health) that varied across different time points, with scores generally ranging in the 0.72–0.89 range across both groups at different measurements. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01107665 · results posted 1 February 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people, all of whom received a combination of two medicines — pazopanib and paclitaxel. The trial had one treatment group only, with no comparison group. It was measuring how participants' cancer progressed over time, how many were still alive at certain points, and how their tumours responded to the treatment. Of the 60 people who started, 11 completed the study and 49 did not complete it. The reported data shows that the main thing being measured — the percentage of participants whose cancer had not progressed at six months — was 68%. For the additional measures: 48% of participants were reported to be alive at one year after joining the trial, and 27% were reported to be alive at two years. When it came to tumour response, 36% of participants were recorded as having their tumour shrink by a meaningful amount (either fully disappearing or reducing in size by at least 30%). A broader measure that also included people whose cancer stayed stable — meaning it neither shrank significantly nor grew — was reported at 91%. Among those whose tumours did respond, the reported average length of time that response lasted was approximately 352 days (just under one year). It is worth noting that these figures come from a single group of 60 participants, and the data was submitted by the trial sponsor to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02905266 · results posted 8 January 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 53 participants in each of two groups — one group received a "Fixed Ratio Combination" (both medicines given together in a single infusion at a set ratio) and the other received a "Sequential Combination" (the medicines given one after the other). The trial was measuring how the two medicines, ipilimumab and nivolumab, behaved in the body and tracking certain unwanted effects (called adverse events, or AEs) that participants experienced during treatment. Participant numbers fell over the course of the trial: by the final maintenance phase, only 8 participants in the Fixed Ratio group and 14 in the Sequential group were still taking part. The reported data shows that no participants in either group (0%) experienced the most severe allergic-type reactions (anaphylactic reactions). A small percentage experienced hypersensitivity or infusion-related reactions — reported as 7.5% in the Fixed Ratio group and 9.4% in the Sequential group. For more serious unwanted effects overall (graded 3–5 on a standard severity scale, meaning significant or worse), the reported figures were 69.8% in the Fixed Ratio group and 56.6% in the Sequential group. When looking only at unwanted effects considered related to the study drugs, the reported figures were 58.5% and 47.2% respectively. The reported data also shows drug concentration levels measured in participants' blood at the end of each infusion across multiple time points, with values for both medicines appearing broadly similar between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00301067 · results posted 28 December 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two drugs — temozolomide (a chemotherapy medicine) and calcitriol (a form of vitamin D) — in people with metastatic melanoma (skin cancer that had spread to other parts of the body). The trial was set up in dose groups, or "cohorts," to test increasing amounts of calcitriol and to find the highest dose that could be given without causing serious side effects. A total of 20 participants were enrolled across four groups: 4 in Cohort 1 (the lowest calcitriol dose), 3 in Cohort 2, 3 in Cohort 3 (the highest dose tested), and 10 in an expansion group. The trial measured whether serious dose-related side effects occurred, what other side effects were seen, and how tumours responded to the treatment. The reported data shows that, across the three dose-escalation cohorts, zero participants experienced what the trial defined as a "dose-limiting toxicity" — that is, a severe side effect judged to be directly caused by calcitriol. Regarding other notable side effects (rated as severe or life-threatening and possibly linked to either drug), 1 participant in Cohort 1 and 1 participant in the expansion group were recorded as having such events, while Cohorts 2 and 3 recorded none. For tumour response across all 20 participants combined, the reported data shows: 0 had a complete response (all tumour lesions disappeared), 2 had a partial response (tumours shrank by at least 30%), 1 had stable disease (tumours neither shrank enough to count as a response nor grew enough to count as progression), and 17 had progressive disease (tumours continued to grow). The reported data also shows that 2 participants in total had an overall response (combining complete and partial responses), and the reported median time to progression — meaning the midpoint of how long it took before the disease started growing again — was approximately 1.81 months. The secondary outcome examining vitamin D receptor gene variations and their relationship to tumour response was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01810016 · results posted 30 November 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01810016) enrolled a total of 8 people across three groups. Group A (called "Arm A") had 5 participants and received ipilimumab (a cancer immunotherapy drug) combined with a form of a cancer-related protein called NY-ESO-1. Group B ("Arm B") had 2 participants and received ipilimumab with a different form of the NY-ESO-1 vaccine. Group C ("Arm C") had 1 participant and received ipilimumab with the same vaccine form as Group B but at a different dose or schedule. The trial was primarily measuring how many participants experienced adverse events (unwanted health events that occurred during treatment), and secondarily looking at how participants' tumours responded. The reported data shows that when it came to adverse events, all 5 participants in Arm A, both participants in Arm B, and the 1 participant in Arm C experienced at least one treatment-emergent adverse event (that is, an unwanted health event that appeared after treatment began). Of those, 1 person in Arm A and 1 person in Arm B experienced what the trial defined as a dose-limiting toxicity — meaning a serious enough adverse event to potentially affect dosing decisions. Regarding tumour response, the reported data shows that among the participants who completed assessments, 4 people in Arm A had what was classified as stable disease (meaning their tumour burden neither shrank significantly nor grew significantly), while 2 people in Arm B had a partial response (meaning their tumour burden decreased by 50% or more). One person each in Arms A and C had progressive disease (meaning their tumour burden increased). No complete responses (full disappearance of tumours) were recorded in any group. No tumour response data was reported for participants who did not complete the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01328535 · results posted 7 November 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people, all of whom received a form of individualised chemotherapy. Twenty-four participants completed the study and one did not. The trial was measuring how long people went without their cancer getting worse (called "progression-free survival"), how long people lived overall, and what side effects occurred. Participants were split into two groups — one received chemotherapy timed to a specific schedule, and the other received the same chemotherapy without that timing approach. The reported data shows that for the primary goal — the proportion of patients who had not experienced disease progression at four months — 22.2% of participants in the timed chemotherapy group met this measure. For the secondary outcomes, the median time before disease progression (that is, the midpoint time at which half the group had seen their cancer worsen) was reported as 3.4 months in the timed chemotherapy group and 7.2 months in the untimed chemotherapy group. The median overall survival (the midpoint time from the start of the trial to death from any cause) was reported as 23.1 months in the timed group and 17.5 months in the untimed group. Regarding side effects, the reported data shows that between roughly 4% and 25% of patients experienced serious side effects (graded as severe or worse and considered at least possibly related to treatment), depending on the type of side effect. Two additional pre-specified outcome areas — looking at immune system markers and how they related to the timed chemotherapy approach — had no numerical results reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01667419 · results posted 17 October 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called vemurafenib in people who had been treated for melanoma (a type of skin cancer). The trial was divided into two groups of participants — Cohort 1 and Cohort 2 — based on their stage of disease. In total, 498 people took part: 157 received vemurafenib and 157 received a placebo (an inactive treatment) in Cohort 1, and 93 received vemurafenib and 91 received a placebo in Cohort 2. The trial was mainly measuring how long people went without their melanoma coming back or spreading, using MRI and CT scans to track this. The reported data shows that for the main outcome — the time from the start of the trial until the cancer returned, a new melanoma appeared, or a person died — the Cohort 1 vemurafenib figure was listed as "not available" (meaning a result was not reported for that group), while the Cohort 1 placebo group had a reported median (the midpoint value in the dataset) of 36.9 months. In Cohort 2, the vemurafenib group had a reported median of 23.1 months and the placebo group 15.4 months. For the secondary outcome measuring time until the cancer spread to distant parts of the body, Cohort 2 reported 37.2 months for vemurafenib and 30.7 months for placebo; the Cohort 1 figures were not reported. For overall survival (time until death from any cause), only the Cohort 2 vemurafenib group had a reported figure of 59.9 months; the other three groups' figures were not reported. The reported data also shows that medical events (called adverse events) were recorded in 99.4% of Cohort 1 vemurafenib participants, 88.5% of Cohort 1 placebo participants, 100% of Cohort 2 vemurafenib participants, and 89.0% of Cohort 2 placebo participants. The reported data also included quality-of-life scores measured using a standard questionnaire, where changes of 5–10 points are considered meaningful to participants. The reported changes from the starting score across the different time points and groups ranged from 0.0 to 16.7 points, with some variation between the vemurafenib and placebo groups at different stages. Blood levels of vemurafenib in those who received the drug were also measured and reported at various time points throughout the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01682083 · results posted 26 September 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 438 people in the active treatment group (receiving a combination of two medicines, dabrafenib and trametinib) and 432 people in the placebo group (receiving dummy versions of both medicines). All participants had melanoma skin cancer that had been surgically removed but carried a specific gene change (BRAF mutation), and the trial was measuring whether the combination treatment could delay the cancer coming back or spreading compared to placebo. The main thing being tracked was called "relapse-free survival" — meaning how long people went without their cancer returning or dying from any cause. The reported data shows that, for the primary measure of relapse-free survival, 163 out of 438 people (roughly 37%) in the active treatment group experienced a relapse event (such as the cancer returning locally, spreading to other parts of the body, a new melanoma forming, or death), compared with 247 out of 432 people (roughly 57%) in the placebo group. For the placebo group, the reported median time before such an event — meaning the point at which half the group had experienced an event — was 16.6 months. For the active treatment group, the median had not been reached by the time data collection was cut off in June 2017, meaning more than half of that group had not yet experienced an event by that point. For overall survival (how long people lived regardless of cause), the median had not been reached in either group by the cut-off date, so a final figure was not reported for either group. The reported data also shows results for a secondary measure called "distant metastasis-free survival" — that is, how long people went without the cancer spreading to distant parts of the body. In the active treatment group, 106 out of 438 people experienced such an event, compared with 150 out of 432 in the placebo group. The median time for this measure was not reached in either group by the analysis cut-off, so a final figure was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01978236 · results posted 17 August 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01978236) enrolled 6 participants, all in a single group called Cohort A. Four participants completed the study, while two did not. The trial was measuring how much of a drug called dabrafenib — and its breakdown products (known as metabolites) — could be detected in participants' blood (plasma), brain tumour tissue, and cerebrospinal fluid (the fluid surrounding the brain and spinal cord) around the time of surgery to remove brain metastases (cancer that has spread to the brain). The reported data shows a range of dabrafenib and metabolite levels across the different samples collected. In blood plasma, the reported individual measurements ranged from around 1.24 to 438 nanograms per millilitre (a nanogram is an extremely tiny unit of measurement). In the brain tumour tissue itself, individual reported measurements ranged from 0 (undetectable) up to 628 nanograms per millilitre, with considerable variation between participants. For cerebrospinal fluid, samples were only collected from one participant, and the four reported measurements for that person ranged from 0.00 to 36.9 nanograms per millilitre. Several planned measurements — including analysis of tumour pathway markers and changes in tumour appearance on scans — were not performed because the trial was stopped early due to difficulties recruiting enough participants. That data was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01006252 · results posted 17 July 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01006252) enrolled 168 participants in each group — one group received tasisulam-sodium and the other received paclitaxel (a chemotherapy drug used as a comparison). All 168 participants in each group were recorded as having completed the study. The trial was primarily measuring how long participants lived overall (called "overall survival"), and also tracked a number of secondary measures including how long it took for the cancer to grow or spread, whether tumours shrank, and participants' quality of life. The reported data shows that the median overall survival — that is, the midpoint at which half the participants had passed away and half were still alive — was 6.77 months for the tasisulam-sodium group and 9.36 months for the paclitaxel group. For progression-free survival (the time until the cancer showed signs of growing or the participant died), the reported figures were 1.94 months for tasisulam-sodium and 2.14 months for paclitaxel. When it came to tumour response, no participants in either group had a complete response (disappearance of all target tumour areas), and 3.0% of the tasisulam-sodium group and 4.8% of the paclitaxel group had a partial response (tumours shrinking by at least 30%). When stable disease was also included alongside those responses, 30.4% of the tasisulam-sodium group and 33.9% of the paclitaxel group fell into that broader category. Because so few participants responded in either group, a planned analysis of how long responses lasted was not able to be carried out, and no data was reported for that measure. The reported data also shows that the time until a meaningful worsening in quality-of-life scores (as measured by a melanoma-specific questionnaire) was 2.96 months for the tasisulam-sodium group and 3.52 months for the paclitaxel group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00383292 · results posted 6 June 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 130 people in total across three groups, each receiving a different dosing approach of an experimental drug called tasisulam. The first group (68 people) was given a dose aimed at reaching a blood level target of 420 μg/mL, the second group (32 people) was aimed at a lower target of 360 μg/mL, and the third group (30 people) had their dose calculated based on their individual albumin (a protein in the blood) levels. The trial was primarily measuring how many participants' tumours shrank or disappeared — known as an "objective response" — and also tracked how long participants went without their disease getting worse, how long they survived overall, and other related measures. The reported data shows that the percentage of participants whose tumours shrank or disappeared (the primary measure) was 10% in the first group, 6% in the second group, and 7% in the third group. For the secondary measures, the reported time until the disease progressed or participants died (called progression-free survival) was 2.8 months in both the first and second groups, and 3.5 months in the third group. When looking at participants who had their tumours shrink or stay stable for at least two treatment cycles, the reported figures were 47%, 47%, and 50% across the three groups respectively. The reported overall survival times (from the start of the trial until death from any cause) were 10.5 months, 11.9 months, and 20.1 months for the three groups. Among those who did respond to treatment, the reported duration of that response was 5.6, 7.2, and 4.1 months respectively. A measure of how quickly the body cleared the drug from the bloodstream was also reported for the combined participant group as 0.0275 litres per hour. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01533948 · results posted 9 May 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 25 participants, all of whom received the study drug axitinib. All 25 participants completed the study. The trial was measuring how often tumours shrank or disappeared in response to axitinib, how long participants went without their disease getting worse, how long participants lived overall, and what side effects occurred. The reported data shows that 12% of participants — roughly 3 out of 25 people — had their tumours shrink or disappear (a result called an "overall response," meaning either the tumour completely disappeared or shrank by at least 30%). For how long disease stayed stable without getting worse, the reported middle value (the point at which half the group had progressed and half had not) was 2.1 months. The reported middle value for overall survival — the point at which half the group had passed away and half had not — was 7.4 months. Regarding side effects, 12 out of 25 participants experienced at least one "Grade 3" adverse event, meaning a serious side effect considered severe in nature. For the measure looking at circulating tumour cells (cancer cells detected in the bloodstream) in people who responded to treatment, the reported baseline value was 0 cells per cubic millimetre — though what this figure represents in context was not further explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01689974 · results posted 23 February 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01689974) enrolled 10 people in total — 5 in a group receiving the drug ipilimumab on its own (Arm A), and 5 in a group receiving ipilimumab combined with radiation therapy (Arm B). The trial was designed to measure and compare the response rates between the two groups — that is, how many participants in each group showed a measurable reduction in tumours at sites in the body that had not been directly treated with radiation. All participants had advanced (metastatic) melanoma with at least two measurable areas of disease. The reported data shows that none of the 10 participants were recorded as having completed the study, with all 10 listed under "not completed." This likely reflects that the trial did not run its full course, though the specific reason for this is not stated in the data provided here. For the primary outcome — the actual response rate numbers for each group — the data was not reported on ClinicalTrials.gov. No figures were submitted for how many participants in either arm showed a response, so it is not possible to describe what those results were. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01721603 · results posted 23 January 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — dabrafenib and trametinib — given together with a type of targeted brain radiation called Gamma Knife radiosurgery (also known as stereotactic radiosurgery). The trial was designed for people with a specific type of melanoma that had spread to the brain (up to four brain lesions, none larger than 3 cm), and whose tumours carried a particular genetic change called BRAF V600E. The main question the trial was trying to answer was how many participants went six months without new brain tumours appearing elsewhere in the brain — a measure called "distant brain metastasis-free survival." The reported data shows that only 2 people joined the trial and both of them completed it. This is a very small number — far fewer than would typically be needed to draw broad conclusions. Of the two participants, 1 person reached the six-month mark without new brain tumours appearing in other parts of the brain (the primary outcome). For the secondary outcomes — which looked at other things like local tumour control at six months, best overall tumour response, and the overall response in the body — the reported data also shows 1 participant met each of those measures. For two of the secondary outcomes (median time until new brain tumours appeared, and median time to disease progression in the brain), no numbers were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01693068 · results posted 5 January 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01693068) enrolled 194 participants across two main groups: 64 people were assigned to receive dacarbazine (a standard chemotherapy) and 130 were assigned to receive pimasertib (an investigational drug). Of the dacarbazine group, 41 participants later crossed over to receive pimasertib when their disease progressed. The trial's main goal was to measure how long participants went without their cancer growing or spreading — known as "progression-free survival" — and to compare this between the two groups. The reported data shows that, on average, participants in the dacarbazine group went approximately 6.9 weeks before their disease progressed or they died, compared to approximately 13.0 weeks in the pimasertib group. For the secondary measurements, the proportion of participants whose tumours shrank or disappeared (called the "objective response rate") was reported as 14.1% in the dacarbazine group and 26.9% in the pimasertib group. The proportion whose disease was kept under control for more than three months (the "disease control rate") was 15.6% for dacarbazine and 33.1% for pimasertib. Roughly 9.4% of the dacarbazine group and 17.3% of the pimasertib group were still progression-free at the six-month mark. The reported data also shows figures for overall survival — that is, how long participants lived from the start of the trial. The median overall survival was reported as approximately 10.6 months for the dacarbazine group and 8.9 months for the pimasertib group. At the 12-month point, 44.5% of the dacarbazine group and 43.3% of the pimasertib group were reported to be alive. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01307397 · results posted 18 December 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 3,219 participants, all of whom received the drug vemurafenib. The trial was a single-arm study — meaning there was no comparison group — and it was primarily focused on tracking side effects and how the drug was taken over time, rather than comparing it against another treatment. All 3,219 participants were recorded as having completed their involvement in the study. The reported data shows that 52.8% of participants experienced at least one serious side effect rated as "severe" or "life-threatening" (Grades 3 or 4 on a standard medical scale). Regarding the drug being interrupted or stopped due to side effects, two separate figures were reported: 7.0% had their dose interrupted and 34.0% discontinued the drug due to a side effect — though the data as submitted does not clearly label which figure corresponds to which outcome. The reported data also shows a range of specific side effects were tracked: skin-related squamous cell carcinoma was reported in 42.3% of participants, rash in 47.9%, sensitivity to sunlight in 28.4%, joint pain in 36.8%, fatigue in 14.6%, and liver injury in 1.7%, among others. On average, participants took the drug for approximately 9.4 months (excluding time when doses were missed) and received a mean total dose of around 501 grams over the course of treatment, at roughly 1.8 grams per day. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00715793 · results posted 3 October 2017

According to the results reported on ClinicalTrials.gov, this trial looked at combining two medicines — decitabine (DAC) and temozolomide (TMZ) — in people with cancer. The trial had two stages: a smaller Phase 1 stage to find the right dose, and a larger Phase 2 stage to measure how participants' tumours responded. In total, 10 people took part in the Phase 1 dose-finding stage (4 in the lower-dose group and 6 in the higher-dose group), and 29 people took part in the Phase 2 stage, all receiving the higher dose of 0.15 mg/kg of decitabine combined with temozolomide. The reported data shows that in the Phase 1 stage, none of the 4 participants on the lower dose (0.075 mg/kg) experienced what the researchers defined as a "dose-limiting toxicity" — meaning a serious side effect serious enough to limit the dose — while 17% of those on the higher dose (0.15 mg/kg) did. Based on this, the recommended dose going into Phase 2 was recorded as 0.15 mg/kg of decitabine. In the Phase 2 stage, the reported "overall response rate" — the percentage of participants whose tumours showed a measurable reduction — was 18%. The reported "disease control rate," which also includes participants whose tumours neither shrank nor grew significantly, was 61%. The reported median time until disease progression (the point at which the disease was seen to worsen) was 3.4 months, and 32.4% of participants had not experienced progression at the 6-month mark. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01844505 · results posted 26 September 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01844505) enrolled 945 people in total — 316 in the nivolumab-alone group, 314 in the nivolumab-plus-ipilimumab combination group, and 315 in the ipilimumab-alone group. The trial was measuring how long participants went without their cancer getting worse (called "progression-free survival"), how long participants lived overall ("overall survival"), and the proportion of participants still alive or still progression-free at set points in time (6, 12, and 24 months). The reported data shows that, for how long participants went without their disease getting worse, the median time (meaning the point at which half the group had experienced progression or death) was approximately 6.9 months for the nivolumab-alone group, 11.5 months for the combination group, and 2.9 months for the ipilimumab-alone group. For overall survival, the reported secondary outcome data shows median survival times of approximately 36.9 months for nivolumab alone, 71.9 months for the combination, and 19.9 months for ipilimumab alone (the primary overall survival measure was noted as "not available/not reached" for the nivolumab and combination groups at the time of the primary analysis). Looking at survival rates at 24 months, the reported data shows that approximately 59% of the nivolumab-alone group, 64% of the combination group, and 45% of the ipilimumab-alone group were recorded as still alive at that time point. The reported data shows that for progression-free survival at 24 months, approximately 37% of the nivolumab-alone group, 43% of the combination group, and 12% of the ipilimumab-alone group had not experienced disease progression or death. These figures are as submitted by the trial sponsor and represent what was observed and recorded in this specific group of trial participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00405587 · results posted 22 August 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 109 people across four groups. Twenty-six participants received the study drug (RO5185426, also known as vemurafenib) in an original tablet formulation at escalating doses, 30 received a modified formulation at escalating doses, 32 had BRAF-mutation-positive melanoma in an extension phase, and 21 had BRAF-mutation-positive bowel cancer (colorectal cancer) in an extension phase. The trial was primarily measuring how the drug moved through the body — specifically how much of the drug was present in the bloodstream over time, how high the concentration peaked, and how quickly it reached that peak. The reported data shows the following for the original formulation dose-escalation group. On Day 1, the amount of drug measured in the blood over eight hours (a standard way researchers track how much of a medicine the body absorbs) ranged from 2.02 to 4.47 micrograms per millilitre per hour across the four dose levels (200 mg, 400 mg, 800 mg, and 1600 mg). By Day 15, those same figures had risen considerably, ranging from 9.37 to 33.89, suggesting the drug built up in the body over time. The highest blood concentration reached on a single dose (Day 1) ranged from 0.37 to 0.85 micrograms per millilitre, and by Day 15 this had increased to between 1.34 and 5.41 micrograms per millilitre. The time it took to reach peak concentration on Day 1 ranged from about 3 to 10 hours depending on dose. No outcome data for the modified formulation group or the extension-phase groups was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01864538 · results posted 16 August 2017

According to the results reported on ClinicalTrials.gov, this trial involved 11 participants, all of whom received a treatment called TH-302. The trial was measuring overall survival — that is, tracking how many participants were still alive over the course of the study. All 11 participants were enrolled, though none were recorded as having "completed" the trial in the formal sense, meaning all 11 fell into the "not completed" category (which can happen for a range of reasons, such as the study ending early or participants leaving before the scheduled end point). The reported data shows that the primary outcome — overall survival — was measured across all 11 participants. Beyond the participant count of 11 being noted against this outcome, no further numerical breakdown (such as survival times or rates) appears to have been reported in the structured results submitted to ClinicalTrials.gov. No secondary outcome measures were included in the data provided. It is worth noting that, with only 11 participants, this was a very small study, and the data as submitted is limited in detail. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01612221 · results posted 31 July 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01612221) enrolled 100 adults in total — 50 people who received a supplement called N-acetylcysteine (NAC) and 50 who received a placebo (a dummy treatment with no active ingredient). All 100 participants completed the study with no dropouts. The trial was measuring the effect of NAC on a specific type of damage — called oxidative stress — that ultraviolet (UV) light causes to moles (nevi) on the skin. To do this, researchers looked at a biological marker called 8-OG, which is a substance that appears in cells when they are damaged by UV light. The reported data shows that, for the primary measurement — the percentage of mole tissue showing 8-OG damage — UV-exposed moles had high levels in both groups (94.6% in the NAC group and 96.2% in the placebo group). In moles that were not exposed to UV light, the reported figures were 33.6% in the NAC group and 33.1% in the placebo group. For the secondary measurement, which looked at other biological markers of UV-related oxidative stress in the moles, the reported values across three separate markers were 8.99, 9.29, and 8.73 in the NAC group, compared with 9.14, 9.40, and 9.03 in the placebo group. The data does not include further detail about what specific units or scales these secondary marker figures refer to. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00525031 · results posted 2 July 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 52 people in total — 27 in a group receiving a medicine called temozolomide (TMZ) on its own, and 25 in a group receiving temozolomide combined with another medicine called pegylated interferon-alpha 2b (sometimes shortened to PGI). The trial was measuring how participants' tumours responded to treatment given before a main procedure (called "neoadjuvant" therapy). Responses were grouped into four categories: complete response (tumour disappears entirely), partial response (tumour shrinks by 30% or more), stable disease (tumour neither shrinks enough to count as a partial response nor grows enough to count as progressive disease), and progressive disease (tumour grows or new lesions appear). Almost all participants — 26 in the TMZ-only group and 24 in the combination group — completed the study. The reported data shows the following breakdown by group. In the TMZ-alone group: 4 participants had a complete response, 14 had a partial response, and 8 had stable disease. In the TMZ-plus-PGI group: 7 participants had a complete response, 11 had a partial response, and 6 had stable disease. Looking across all 52 participants combined, the reported data shows 1 complete response, 15 partial responses, 3 cases of stable disease, and 31 participants overall recorded in the response categories — though it should be noted the overall figures as submitted appear to differ from the per-group totals, and no further explanation for this was included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01495988 · results posted 23 June 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01495988) enrolled a very small number of participants across four treatment groups: a group receiving vemurafenib alone (5 people), a group receiving vemurafenib combined with bevacizumab (3 people), and a group receiving vemurafenib combined with cobimetinib plus bevacizumab (2 people). No participants were recorded in the vemurafenib/cobimetinib-only group. The trial was studying people with advanced (stage IV) melanoma carrying a specific gene change (called BRAF V600E or V600K), and it aimed to measure things such as the highest tolerable dose of bevacizumab when added to the other medicines, how long participants went without their cancer growing (called progression-free survival), how long participants lived overall, how often tumours responded to treatment, and the side-effect profile of the treatments. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — including the primary outcomes (maximum tolerated dose and progression-free survival) and all secondary outcomes (overall survival, response rates, side-effect profile, and tumour biology studies). In other words, no figures, measurements, or findings were provided in the results data for any of the four groups. Given that only 10 people in total were recorded across the study periods — a very small number compared with what most trials plan for — it is possible the trial closed before enough data could be collected, though the reason for the missing results data was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00518206 · results posted 23 June 2017

According to the results reported on ClinicalTrials.gov, this trial involved 46 people with cancer who were divided into two groups. Twenty-seven participants received a vaccine called NY-ESO-1 ISCOM on its own (Cohort 1), while 19 received the same vaccine combined with a drug called cyclophosphamide (Cohort 2). The trial was measuring how tumours responded to the vaccine, as well as how the immune system reacted to it and what unwanted side effects were recorded. Of those who started, 16 people in Cohort 1 and 13 in Cohort 2 completed the study. The reported data shows that when tumour responses were assessed, 1 person in each group showed a complete response (meaning all detectable tumour signs disappeared on scans), and 12 people in Cohort 1 versus 4 in Cohort 2 showed a partial response (tumour shrinkage of at least 30%). Stable disease (tumour neither growing nor shrinking enough to qualify for another category) was recorded in 12 people in Cohort 1 and 14 in Cohort 2. For immune system activity in the blood, the reported data shows that various T-cell responses (a type of immune cell response) were detected in a number of participants across both groups both before and after vaccination, with figures varying by measurement type and timing. Regarding antibody responses (another part of the immune system), 19 participants in Cohort 1 and 8 in Cohort 2 were reported as not having detectable antibodies at the start but developing them during the study. On the question of unwanted effects, all 27 participants in Cohort 1 and all 19 in Cohort 2 were reported as experiencing at least one treatment-emergent adverse event (an unwanted effect that appeared during treatment). More serious adverse events of a higher severity grade were reported in 4 people in Cohort 1 and 9 in Cohort 2, while dose-limiting toxicity (a pre-defined level of serious side effect) was recorded in 1 person in each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02057393 · results posted 6 June 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 89 people, all of whom received the same treatment being studied — a dye called indocyanine green (ICG). Of those 89 participants, 87 completed the study and 2 did not. The trial was looking at whether ICG, used with a real-time imaging technique called lymphangiography (a way of tracking how fluid moves through the body's lymph system), could find "sentinel nodes" — the first lymph nodes that cancer cells might spread to — just as reliably as the existing standard methods, which use a radioactive tracer called technetium-99 and a blue dye. The reported data shows that the main thing being measured was how many sentinel nodes per person were identified using the ICG method. The result reported was an average of 1.87 sentinel nodes identified per patient. No comparison figures for the technetium-99 or blue dye methods were included in the structured results data submitted, so a direct numerical comparison between the methods cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01886235 · results posted 6 June 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 10 participants, all of whom completed the study with none dropping out. The trial was testing a imaging technique called intravital microscopy — a method of looking at living tissue in fine detail — to see whether it could be used to examine blood vessels inside melanoma (skin cancer) tumours during routine surgical removal. Specifically, the researchers wanted to see if they could identify tumour blood vessels, measure their size, count how many vessels were present, and observe a dye (fluorescein) moving through those vessels. The reported data shows that in 70% of participants (7 out of 10), the imaging procedure was considered successful by the study's own definition. The reported average blood flow rate measured within tumour vessels was 270 micrometres per second. No participants experienced a complication that disrupted the surgical procedure or caused an unexpected adverse event beyond what normal surgery would involve. However, the reported data shows that 40% of participants (4 out of 10) experienced some form of adverse event of any kind during the study. For two other measures — how long participants lived overall and how long they went without the disease progressing — the data was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02155322 · results posted 11 April 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02155322) enrolled 33 people, of whom 32 received the study treatment — a medication called PEG-IFN (pegylated interferon). The trial was primarily focused on tracking unwanted or unexpected changes in participants' health (called adverse events) during the study, and looking at how many people stopped taking the study drug because of these events. By the end of the study, 19 participants had completed it, while 14 did not finish. The reported data shows that 100% of the 32 treated participants experienced at least one adverse event — that is, some kind of unfavourable or unintended change in their body during the study period. It is important to note that this does not necessarily mean these changes were caused by the treatment; the trial recorded any such change, whether or not it was thought to be related to the study drug. Separately, the reported data shows that 3.1% of participants (roughly 1 person out of the 32 treated) stopped taking the study drug specifically because of an adverse event. No other outcome measures were included in the data submitted to ClinicalTrials.gov for this trial, so no further figures can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01515189 · results posted 24 March 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 727 people with melanoma, split into two groups: 365 received a higher dose of ipilimumab (10 mg/kg) and 362 received a lower dose (3 mg/kg). The trial was primarily measuring how long participants lived overall (called "overall survival"), and also tracked secondary measures such as how long it took for the disease to progress, how many participants' tumours shrank or disappeared, and how long those responses lasted. The reported data shows that, for overall survival — the main thing being measured — the median time participants lived after joining the trial was 15.7 months in the higher-dose group and 11.53 months in the lower-dose group. (Median means half the participants in each group lived longer than that figure, and half lived a shorter time.) For progression-free survival — the time before the disease got worse or a participant died — the reported median was 2.83 months in the higher-dose group and 2.79 months in the lower-dose group. In terms of tumour response, about 15.3% of participants in the higher-dose group and 12.2% in the lower-dose group had their tumours shrink or disappear. When stable disease (where tumours neither clearly shrank nor grew) was also counted, the figures were 31.5% and 27.9% respectively. Among those who did respond, the reported median duration of that response was around 16.33 months (higher dose) and 15.90 months (lower dose). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00976573 · results posted 7 March 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 149 people across two groups. Seventy-five participants received a combination of three medicines — bevacizumab, paclitaxel, and carboplatin (Group A) — while 74 received those same three medicines plus a fourth, everolimus (Group B). The trial was measuring how long participants went without their cancer growing or spreading (called "progression-free survival"), as well as tracking tumour responses, how long participants lived overall, and side effects linked to treatment. The reported data shows that for the main measure — time without the cancer progressing — Group A had a reported median of 5.6 months, while Group B had a reported median of 5.1 months. A median figure means half the participants in that group reached that time point and half did not. For overall survival (time from enrolment until death from any cause), the reported median was 14.5 months for Group A and 10.8 months for Group B. When it came to tumour response (the cancer visibly shrinking on at least two scans taken at least 8 weeks apart), 13% of participants in Group A and 23% in Group B met that measure, according to the reported figures. Regarding side effects considered serious (graded 3 or higher and linked to treatment), the reported data shows 35% of Group A participants and 58% of Group B participants experienced at least one such event; additional breakdowns of specific side effects were also reported, but the full detail sits in the trial's adverse events section. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01820364 · results posted 9 January 2017

According to the results reported on ClinicalTrials.gov, this trial had two parts and enrolled a total of 16 participants — 15 in Part I, who received a single drug called LGX818, and 1 in Part II, who received a combination of LGX818 and a second drug called MEK162. The trial was measuring how tumours responded to these treatments, using a standard set of rules called RECIST (Response Evaluation Criteria in Solid Tumours), which categorises tumour changes as: complete response (all signs of tumour disappear), partial response (tumours shrink by at least 30%), stable disease (tumours neither shrink enough to count as a response nor grow enough to count as progression), or progressive disease (tumours grow by at least 20%). The trial was stopped early due to not enough patients being enrolled, which meant several planned measurements could not be completed. The reported data shows the following tumour response results for the 15 participants in Part I (single drug): 1 participant had a complete response, 8 had a partial response, 1 had stable disease, 2 had progressive disease, and 3 were not able to be assessed. For the single participant in Part II (combination treatment), the reported data shows that person experienced progressive disease — meaning their tumours grew — and they left the trial on Day 22 of that part of the study. Because the trial was stopped before enough participants were enrolled, the reported data shows that several planned secondary measurements — including assessments of drug levels in the blood, certain biological markers, and a formal review of side effects for the combination treatment — were not carried out and no results were reported for these outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01477463 · results posted 23 December 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01477463) enrolled 24 people in total — 18 in the vitamin D group and 6 in the placebo group. All 24 participants completed the study. The trial was looking at how vitamin D supplementation might affect the activity of genes in skin moles (benign growths), particularly genes that are known to behave differently in melanoma (a type of skin cancer) compared to ordinary moles. The aim was to understand molecular changes in gene activity, not to treat cancer directly. The reported data shows that, among participants who received vitamin D, around 270 genes showed some change in their activity levels. Of those 270 genes, 47 overlapped with a set of more than 2,300 genes that a previous study had identified as behaving differently in melanoma cells compared to normal moles. These are the primary outcome numbers as submitted — the trial was measuring gene activity patterns, not clinical symptoms or disease outcomes. For the secondary outcomes, the reported average vitamin D blood level (a measure called serum 25(OH)D, which reflects how much vitamin D is circulating in the body) was approximately 47 ng/ml in the vitamin D group and approximately 30 ng/ml in the placebo group. The reported data also shows that no participants in either group experienced high calcium levels (hypercalcaemia), which was being monitored as a sign of vitamin D toxicity. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01133977 · results posted 10 October 2016

According to the results reported on ClinicalTrials.gov, this trial involved 97 people in total across two stages. The first stage (Phase 1b) enrolled 16 people and tested three different doses of a drug called lenvatinib (16 mg, 20 mg, or 22 mg) given together with another drug called dacarbazine, mainly to see what side effects occurred at each dose level. The second stage (Phase 2) enrolled 81 people, who were randomly assigned to either receive the 20 mg lenvatinib plus dacarbazine combination (42 people) or dacarbazine alone (39 people). This stage was measuring how long people went without their disease getting worse. The reported data shows that in the first stage, when looking at serious early side effects (called "dose-limiting toxicities" — meaning significant unwanted reactions within the first 21 days of treatment that doctors thought were related to the study drugs), none occurred in the 16 mg group, 1 out of 7 occurred in the 20 mg group, and 2 out of 6 occurred in the 22 mg group. Across all groups, the number of participants who experienced any recorded adverse event (an unwanted reaction of any kind) was: 3 of 3 (16 mg group), 7 of 7 (20 mg group), 6 of 6 (22 mg group), 40 of 42 (Phase 2 lenvatinib combination group), and 31 of 39 (Phase 2 dacarbazine-only group). Serious adverse events were recorded in 2, 4, 2, 16, and 1 participants in those same groups respectively. For the main Phase 2 measurement — how long until the disease progressed or a person died — the reported median time (the middle point where half the group had progressed and half had not) was 19.1 weeks in the lenvatinib combination group and 7.0 weeks in the dacarbazine-only group. The reported data shows that figures for overall survival, overall response rate, and time to progression were not fully reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01777776 · results posted 13 September 2016

According to the results reported on ClinicalTrials.gov, this trial tested two investigational drugs — LEE011 (ribociclib) and LGX818 (encorafenib) — used together at different dose combinations. The first part of the trial (Phase Ib) was a dose-finding stage, meaning researchers were trying to work out whether certain dose combinations caused unacceptable side effects in the first 28 days of treatment. A total of 28 people took part across four groups, each receiving a different combination of the two drug doses. No one in any group completed the study, as enrolment was halted before the trial could progress to its second phase (Phase II), which had been planned to look at whether tumours responded to treatment. The reported data shows that in the first group (LEE011 200 mg + LGX818 300 mg, 6 participants), 1 person experienced what is called a "dose limiting toxicity" — meaning a side effect serious enough during the first treatment cycle to potentially affect what dose could be used going forward. No dose limiting toxicities were reported in the other three groups. Because enrolment was stopped early, the researchers were unable to formally determine a maximum tolerated dose. Regarding adverse events (any unwanted medical occurrence), the reported data shows that all 28 participants across all four groups experienced at least one adverse event. Serious adverse events (more significant medical events requiring closer attention) were reported in 3 of 6 participants in the first group, 5 of 12 in the second, 3 of 6 in the third, and 1 of 4 in the fourth group. The reported data shows that all planned Phase II outcomes — including measures of how long participants went without their disease worsening, and whether tumours shrank — were never assessed, as the trial did not progress beyond Phase Ib. Similarly, data on how the drugs moved through participants' bodies over time was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00597272 · results posted 10 August 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 34 participants, spread across seven groups (called cohorts). The groups ranged in size from 1 participant each (Cohorts 1A, 1B, 2A, and 2B) to 10 participants each (Cohorts 1C, 2C, and 3). All 34 participants who started the trial were recorded as having completed it. The trial was measuring toxicity — that is, any harmful or unwanted reactions that participants experienced — using a standard medical grading system called the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The reported data shows the number of participants in each group who experienced toxicity. In Cohorts 1A and 2A (1 participant each), 1 participant per group recorded a toxicity event. The same was true for Cohorts 1B and 2B (also 1 participant each). In Cohort 1C (10 participants), 6 participants were reported as having a toxicity event. In Cohort 2C (10 participants), 7 participants were reported as having a toxicity event. In Cohort 3 (10 participants), all 10 participants were reported as having a toxicity event. No further detail about the nature or severity of these toxicity events was included in the structured data provided. It is worth noting that no secondary outcome measure data was included in the structured results submitted to ClinicalTrials.gov for this trial, so only the toxicity figures described above can be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01378975 · results posted 1 August 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01378975) enrolled 146 people in total — 90 who had not previously received treatment for their brain metastases (Cohort 1) and 56 who had already been treated for them (Cohort 2). The trial was measuring how tumours in and around the brain responded to the study treatment, using detailed imaging scans reviewed by an independent committee. It is worth noting that only a small number of participants — 4 in Cohort 1 and 6 in Cohort 2 — were recorded as having completed the study. The reported data shows that for the primary goal — measuring the proportion of previously untreated participants whose brain tumours showed a confirmed meaningful shrinkage (either complete disappearance or at least a 30% reduction in size) — 17.8% of Cohort 1 met that threshold. For the previously treated group (Cohort 2), the reported figure for the equivalent measure was 17.9%. Looking at responses outside the brain, the reported data shows 32.9% of Cohort 1 and 22.5% of Cohort 2 met the shrinkage criteria in those areas. Across both groups, roughly 43% of participants in Cohort 1 and 41% in Cohort 2 were recorded as having stable disease (meaning their tumours neither shrank enough to count as a response nor grew enough to count as progression). The reported data also shows that, among those whose tumours did respond, the response lasted a median (middle value) of approximately 5.6 months in Cohort 1 and 10.7 months in Cohort 2 as assessed by the independent review committee. The time from enrolment until tumours first showed signs of growing again or participants died — known as progression-free survival — was reported as a median of about 3.65 months for Cohort 1 and 3.71 months for Cohort 2. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01519323 · results posted 28 July 2016

According to the results reported on ClinicalTrials.gov, this trial involved six people in total, split into two small groups of three — one group received a lower dose of the drug vemurafenib and the other received a higher dose. The trial was exploring what the maximum tolerated dose of vemurafenib would be when combined with another treatment, and was also looking at how the drug moved through the body, how participants' tumours responded, and how long it took before disease progressed. The reported data shows that the primary goal — establishing a maximum tolerated dose — did not produce a reported numerical result in the submitted data, so that figure is not available here. For the measure of how much of the drug was present in the bloodstream over time (a way of tracking how the body absorbs and processes the medicine), the lower-dose group had reported values of 16,300 and 486,000 units, while the higher-dose group had reported values of 57,000 and 963,000 units across two different time points. All six participants were reported to have experienced at least one adverse event (an untoward medical occurrence during the study). When it came to tumour response, the reported data shows that 0% of participants had their tumour shrink or disappear entirely. However, approximately 67% of participants (roughly 4 out of 6) were reported to have achieved either a response or stable disease lasting at least six weeks. The reported median time before disease progressed was 134.5 days. It is worth noting that with only six participants, this was a very early-stage, small trial primarily designed to explore dosing rather than draw broad conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01910181 · results posted 8 June 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01910181) enrolled 46 participants in total, all of whom received the study drug vemurafenib (also referred to in the data as RO5185426). The 46 participants were split into two groups: a pharmacokinetic (PK) cohort of 20 people, and an expansion cohort of 26 people. The trial was primarily focused on measuring how the drug moves through the body — specifically, how much of the drug ends up in the bloodstream and how high the concentration gets after a dose. None of the 46 participants were recorded as having "completed" the study, though the data does not explain the reasons for this in detail. The reported data shows measurements taken from the 20-person PK cohort at two time points: after the very first dose (Day 1) and after 21 days of dosing. One key measurement was the total amount of drug in the blood over a set period of time (a measure called "area under the curve," or AUC — essentially a way of tracking how much drug the body was exposed to). On Day 1, over an 8-hour window, the reported average figure was 37.54 units (h×µg/mL); by Day 21, that same measurement had risen to 501.28 units. Over a 12-hour window, the figures were 57.51 units on Day 1 and 720.31 units on Day 21. The reported data also shows the peak concentration of the drug in the blood — the highest level measured after a dose. On Day 1, the average peak was 6.93 micrograms per millilitre, and by Day 21 this had risen to 77.55 micrograms per millilitre. No secondary outcome data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01508013 · results posted 2 June 2016

According to the results reported on ClinicalTrials.gov, this trial involved 443 teenagers in total — 214 were assigned to an appearance-focused website intervention and 229 were assigned to a control website. By the end of the study, 182 and 206 participants respectively had completed it. The trial was measuring three things related to indoor tanning (using sunbeds or tanning booths): how many times participants had actually tanned indoors over the past year, how much they intended to use indoor tanning in the next 12 months, and how willing they said they would be to indoor tan in the future. The reported data shows the following numbers at the end of the study. For actual indoor tanning sessions over the past year, the appearance-focused website group reported an average of 5.29 sessions, compared to 6.30 sessions in the control website group. For intentions to indoor tan — measured on a scale from 1 (definitely does not intend to) to 7 (definitely intends to) — the appearance-focused group averaged 2.91 and the control group averaged 3.28. For willingness to indoor tan — also on a scale from 1 (definitely not willing) to 7 (definitely willing) — the appearance-focused group averaged 3.34 and the control group averaged 3.73. No other outcome data was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00003641 · results posted 4 May 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,150 people with melanoma, split into two groups: 569 people in an observation-only group (meaning they were monitored but did not receive active treatment) and 581 people in a group that received a medicine called interferon alfa-2b. The trial was measuring two main things: how many people were still free of their cancer returning after five years, and how many people were still alive after five years. The reported data shows that for the primary measure — the proportion of people whose cancer had not returned after five years — both groups recorded the same result of 0.70, meaning roughly 70 in every 100 participants in each group were reported as relapse-free at the five-year mark. For the secondary measure — the proportion of people still alive at five years — both groups again recorded the same result of 0.83, meaning roughly 83 in every 100 participants in each group were reported as alive at five years. In other words, the numbers reported for both groups were identical on both measures. It is worth noting that not all participants completed the study: 407 people in the interferon group were recorded as completing treatment, while 174 did not complete it, and the observation group had no completions recorded in the same way (as there was no active treatment to complete). Any further detail about why participants did not complete the study was not reported in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01425749 · results posted 4 April 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people in total — 13 in Group A, who received injections into the muscle, and 12 in Group B, who received injections into or just under the skin. All 13 participants in Group A completed the trial, while 11 of the 12 in Group B completed it (one did not finish). The trial was looking at two main things: whether the injections caused any notable side effects, and whether they prompted the body's immune system — the natural defence system — to respond to a cancer-related protein called MAGE-A3. The reported data shows that, for side effects graded as moderate or higher (using a standard medical grading scale), small numbers of participants in both groups recorded events across several categories. For example, 10 people in Group A and 7 in Group B had at least one such event recorded. For the immune response measured in a lymph node near the injection site (a small gland that is part of the body's defence network), 4 participants in Group A and 7 in Group B showed a positive response using one method, while no participants in Group A and 1 in Group B showed a positive response using a second method. In blood samples, 4 in Group A and 6 in Group B showed a positive immune response by one measure, and 1 in Group A and 2 in Group B by another. For antibody responses (a different part of the immune response), the reported data shows that by later time points, 100% of evaluable participants in both groups had a detectable antibody response, though earlier time points showed lower percentages — particularly in Group B. The reported data also includes measurements of specific immune cells at the injection site and in nearby lymph nodes, with figures varying between the two groups across different cell types and time points. The data for the injection-site tissue analysis was only collected and reported for Group B. Some of the secondary outcome figures in the raw data were not accompanied by full labels for each individual time point or category, so a complete breakdown of every number cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01136967 · results posted 16 March 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 182 people with a type of thyroid cancer that had stopped responding to radioactive iodine treatment. Participants were split into two groups based on a genetic feature of their cancer: 93 people whose tumours did not have a specific gene change called V600E BRAF (Cohort 1), and 89 people whose tumours did have that gene change (Cohort 2). The trial was measuring how their cancer responded to a medicine called lenvatinib, looking at things like whether tumours shrank, how long it took for the disease to get worse, and how long participants lived. The reported data shows that the main measure — the proportion of participants whose tumours shrank to a meaningful degree (called the objective response rate) — was 8.6% in Cohort 1 and 9.0% in Cohort 2. For how long it took before the disease progressed, the reported median time was 3.7 months in Cohort 1 and between 1.8 and 2.3 months in Cohort 2 (two slightly different figures were recorded for Cohort 2). The reported median overall survival — how long participants lived from the start of treatment — was 8.9 months in Cohort 1 and 6.3 months in Cohort 2. The reported data also shows that around 53–65% of Cohort 1 and 35–48% of Cohort 2 had their disease at least stay stable for a period of time. All 182 participants experienced at least one adverse event (an unwanted or unexpected health occurrence during the trial), and 39 people in Cohort 1 and 36 people in Cohort 2 experienced a serious adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00104884 · results posted 2 March 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 4 participants, all of whom received a treatment called depsipeptide. The trial was designed to measure how many patients showed a response to the treatment — meaning whether their tumours either disappeared completely or shrank by a meaningful amount, based on a standard measurement system called RECIST (a set of rules used to track changes in tumour size on scans). The reported data shows that none of the 4 participants completed the study — all 4 withdrew or were unable to finish for reasons not detailed in the submitted data. Because no participants completed the trial, the primary outcome — the proportion of patients whose tumours responded to the treatment — was recorded as "not available" (NA). In other words, no result for this measure was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01721772 · results posted 25 February 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01721772) enrolled 418 people with melanoma — 210 were assigned to receive nivolumab (plus a dummy version of the comparison drug), and 208 were assigned to receive dacarbazine (a chemotherapy, plus a dummy version of nivolumab). The trial was primarily measuring how long participants lived overall (called "overall survival"), and also tracked a number of secondary measures including how long participants went without their disease getting worse, what percentage of tumours shrank, and how survival differed depending on a protein marker found on tumour cells called PD-L1. The reported data shows that for overall survival, a median figure (the point at which half of participants had died) was reported as 10.84 months for the dacarbazine group; a corresponding median figure for the nivolumab group was listed as "NA," meaning it was not calculable from the available data at the time of reporting. Looking at survival rates at set time points, the reported data shows approximately 84% of the nivolumab group and 72% of the dacarbazine group were alive at one point in follow-up, and approximately 73% versus 42% respectively at a later point. For progression-free survival — how long before the disease worsened or death occurred — the reported median was 5.06 months in the nivolumab group and 2.17 months in the dacarbazine group. The reported data also shows that approximately 42% of participants in the nivolumab group and 14% in the dacarbazine group had their tumours shrink by a measurable amount. When looking at survival broken down by PD-L1 protein levels on tumour cells, the reported median survival figures were 53.36 months (nivolumab) versus 12.39 months (dacarbazine) in those with higher PD-L1 levels, and 26.97 months versus 10.84 months in those with lower PD-L1 levels. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01866319 · results posted 14 January 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01866319) enrolled 834 people across three groups: 278 received ipilimumab, 279 received pembrolizumab every two weeks, and 277 received pembrolizumab every three weeks. The trial was measuring how long people lived without their cancer growing (called progression-free survival), how many people were still alive at 12 months, and how many people's tumours shrank or disappeared during treatment. The reported data shows that, for progression-free survival — the time from joining the trial until the cancer grew or the person passed away — the median time (meaning half of participants reached this point sooner, half later) was 2.8 months in the ipilimumab group, 5.5 months in the pembrolizumab every-two-weeks group, and 4.1 months in the pembrolizumab every-three-weeks group. For the 12-month survival rate, the reported figures were 58.2% of participants in the ipilimumab group, 74.1% in the pembrolizumab every-two-weeks group, and 68.4% in the pembrolizumab every-three-weeks group still alive at that point. The reported data also shows that the proportion of participants whose tumours shrank or disappeared (called the objective response rate) was 11.9% in the ipilimumab group, 33.7% in the pembrolizumab every-two-weeks group, and 32.9% in the pembrolizumab every-three-weeks group. These figures reflect what was recorded during the trial under specific measurement criteria; they do not represent the full picture of every participant's experience. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00462982 · results posted 30 December 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT00462982) enrolled 8 participants, all of whom received the drug sunitinib. The trial was measuring how tumours in the brain and central nervous system responded to treatment, using a standard set of tumour-measurement rules called RECIST criteria. These rules look at changes in the size of tumours — specifically their longest measurable dimension — using scans such as CT or MRI. Of the 8 people who started the trial, 5 completed it and 3 did not. The reported data shows that the primary outcome — the rate at which brain tumours responded according to RECIST criteria — was measured across participants. The results list two separate figures of 3 and 2 participants respectively under this outcome measure; however, the data as submitted does not clearly label what each of these two numbers specifically represents (for example, whether they refer to different types of response such as partial or complete response). Because those labels are not fully detailed in the submitted data, a precise breakdown cannot be provided here without risk of misrepresenting the findings. It is worth noting that only 8 people took part in this trial, which is a very small number, and 3 did not finish the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00289016 · results posted 18 December 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 50 participants, all of whom received a treatment called talimogene laherparepvec (sometimes called T-VEC). The trial was measuring how tumours responded to the treatment, how long participants survived, and how the disease progressed over time. Of the 50 people who started, 13 completed the trial and 37 did not complete it. The reported data shows that 28% of participants — roughly 14 out of 50 people — had their tumours shrink by at least 30% or disappear entirely, which the trial counted as an "objective response." For the survival measure, the reported middle-point figure (known as the median, meaning half of participants fell above this number and half below) was 448 days. The reported median time until the disease was recorded as getting worse was 146 days. Among those whose tumours did respond, the reported median length of that response was 223 days, and the reported median time from the first dose until a response began was 100 days. Regarding unwanted health events during the trial, the reported data shows that 48 out of 50 participants experienced at least one adverse event (an unwanted health change recorded during the study), and 27 out of 50 experienced a serious adverse event — though the data as submitted lists multiple sub-counts for this outcome and a full breakdown of each category was not clearly separated in the reported figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01009515 · results posted 3 November 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 19 people, all of whom received the same chemotherapy combination — there was no comparison group. Sixteen participants completed the study, and three did not. The trial was primarily measuring the "objective response rate," which is the proportion of participants whose tumours either disappeared completely or shrank by at least 30% during treatment, as assessed by physical examination and/or CT scans. The reported data shows that out of the 19 participants, 1 had a complete response (tumour disappeared entirely) and 3 had a partial response (tumour shrank by 30% or more), giving a combined objective response rate of 4 out of 19 participants. A further 12 participants had stable disease (tumour neither shrank enough to count as a response nor grew enough to count as progression), and 4 participants had progressive disease (tumour grew or new lesions appeared). For the secondary outcomes, the reported data shows a median overall survival — meaning the point at which half the participants had died from any cause — of 47 weeks from the start of treatment. The median time to progression (the point at which half the participants had experienced their disease worsening or had died) was reported as 31 weeks. Side effect data was also recorded and graded in severity, though the reported figures cover multiple categories of adverse events across the 19 participants; the individual breakdown by event type and grade was not fully labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01689519 · results posted 30 October 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01689519) enrolled 495 people with cancer across two groups: 247 received a combination of cobimetinib and vemurafenib, while 248 received vemurafenib plus a placebo (an inactive substance). The trial's main focus was measuring **progression-free survival** — that is, how long participants went without their disease getting worse or dying. Secondary measurements included how long participants lived overall, how many showed a measurable reduction in their cancer (called an "objective response"), and how long those responses lasted. The reported data shows that, for the primary measure of progression-free survival, the cobimetinib plus vemurafenib group had a reported median (the middle value — half of participants above, half below) of approximately 9.9 to 12.6 months across different reporting points, compared to 6.2 to 7.2 months in the placebo plus vemurafenib group. For overall survival, the reported data shows median figures were not available for some earlier reporting points; later figures were approximately 22.3–22.5 months for the cobimetinib combination group and 17.0–17.4 months for the placebo group. For objective response, the reported data shows approximately 67.6%–69.6% of participants in the cobimetinib combination group showed a measurable response, compared to 44.8%–50.0% in the placebo group. Duration of response — how long those responses lasted — was reported as a median of approximately 14.65 months for the cobimetinib combination group and 9.23 months for the placebo group (earlier reporting points were listed as not available). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01107418 · results posted 26 August 2015

According to the results reported on ClinicalTrials.gov, 52 people took part in this trial, all grouped together under a single treatment arm receiving the drug vemurafenib. Participants were divided into four smaller groups (called cohorts), each receiving a different dose: 240 mg, 480 mg, 720 mg, or 960 mg. The trial was primarily measuring how the drug moves through the body — specifically, how much of it gets into the bloodstream and how quickly — at these different dose levels. It is worth noting that none of the 52 participants were recorded as having "completed" the study in the formal sense used in the data, though this may reflect how completion was defined for this particular trial rather than meaning participants dropped out. The reported data shows that on the first day of dosing, the peak amount of vemurafenib measured in the blood ranged from 1.9 micrograms per millilitre (mcg/mL) in the lowest-dose group up to 4.8 mcg/mL in the highest-dose group. The time it took to reach that peak level was reported as 4 hours for the two lower-dose groups and 5 hours for the two higher-dose groups. A measure of the total drug exposure over 24 hours on Day 1 — essentially the area under a graph plotting drug levels over time — was reported as 40.9 units for the 240 mg group, rising to 130.6 units for the 960 mg group. By Day 9 of dosing, the reported data shows that drug levels in the blood were considerably higher than on Day 1 across all groups, with peak blood levels ranging from 15.4 mcg/mL (240 mg group) to 53.2 mcg/mL (960 mg group). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01681212 · results posted 11 June 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01681212) enrolled 21 participants, all of whom were assigned to receive a combination of two treatments: ipilimumab (at a dose of 10 mg/kg) and dacarbazine (at a dose of 850 mg/m²). Of the 21 who started, 15 went on to receive treatment and completed the study, while 6 did not complete it. The trial's main goal was to measure how many participants were still alive one year after starting the study drugs. It also tracked a range of unwanted health events (called adverse events) that occurred during the trial. The reported data shows that 66.7% of participants — roughly two in every three — were recorded as alive at the one-year mark. Regarding unwanted health events, the reported data shows that all 15 treated participants experienced some kind of adverse event, and 15 also experienced what are classified as "Grade 3–4" adverse events, meaning severe or life-threatening in nature. Eleven participants had serious adverse events (significant medical events requiring hospitalisation or similar), and 11 of those were considered related to the study drugs. Nine participants stopped treatment early due to adverse events, and five participants died during the study period. For a specific category of immune-related side effects (reactions thought to be caused by the immune system responding to the drugs), 11 out of 15 participants experienced severe or life-threatening versions of these. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01990859 · results posted 21 May 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, all of whom received the drug ipilimumab. The trial was a single-group study — meaning there was no comparison group — and it was primarily set up to track and count unwanted medical events (called adverse events) that occurred in participants during and after treatment. Participants received four doses of ipilimumab over 12 weeks and were then followed up for a further period. All 20 participants completed the final 90-day follow-up stage, though fewer completed the intermediate follow-up periods. The reported data shows that, during the primary measurement period (the first 12 weeks of dosing plus a further 12 weeks), a range of unwanted medical events were counted across the 20 participants. Six participants experienced what are classified as serious adverse events (significant medical problems requiring hospitalisation or causing major harm), and six participants experienced events that led them to stop taking the study drug. Ten participants had adverse events that investigators considered possibly or probably related to the study drug, and 12 participants experienced what are called immune-related adverse events — unwanted reactions thought to involve the immune system becoming overactive. One participant died during this primary measurement window. The reported data also shows that over the full course of the study, 8 out of 20 participants died in total (across all timepoints, including during and after treatment). Laboratory blood tests showed varying numbers of participants with abnormal results across measures of blood cell counts, liver function, and kidney function, with the specific numbers for each test category reported separately in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01264081 · results posted 19 March 2015

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called lapatinib in people with a type of advanced (metastatic) melanoma that carried a specific genetic change known as an ERBB4 mutation. The trial screened 34 people to see if they were eligible, but only 4 went on to actually receive treatment, and just 2 participants were included in the final analysis. This was a very small trial, and the low number of participants is important to keep in mind when reading the results below. The reported data shows that the main thing being measured was whether participants' tumours shrank or disappeared while on lapatinib — specifically, whether they had what researchers call a "partial response" (tumour shrinks by at least 30%) or a "complete response" (tumour disappears entirely). According to the results reported on ClinicalTrials.gov, neither of the 2 participants analysed had a partial or complete response. The reported data shows that both participants were recorded as having "stable disease," meaning their tumours neither shrank enough to count as a response nor grew enough to count as the cancer getting worse. No participants were recorded as having their disease progress during the study period. For the secondary outcome, the reported data shows that 3 out of the 4 participants who received treatment experienced at least one adverse event (an unwanted medical occurrence), though the breakdown between serious and non-serious events was not separately reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00470470 · results posted 23 December 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people, all of whom received the same treatment referred to as "enzyme inhibitor therapy." The trial was measuring how many participants' tumours responded to the treatment, and how long it took before the disease progressed (got worse). Of the 30 who started, 25 completed the trial and 5 did not finish. The reported data shows that for the main goal — the "objective response rate," which is a measure of how many participants showed a meaningful reduction in tumour size — the results were broken down into four categories: 1 participant had one type of response, 3 had another, 14 fell into a third category, and 7 into a fourth. The specific labels for each of these four categories (for example, "complete response," "partial response," "stable disease," and "progressive disease") were not included in the submitted data, so it is not possible to describe exactly what each number represents. For the secondary goal — how long it took on average before the disease progressed — the reported data shows a figure of 12 weeks, estimated using a standard statistical method called Kaplan-Meier (a common way of calculating time-based outcomes in clinical trials). It is worth noting that because the category labels for the response rate breakdown were not provided in the submitted data, the full picture of those results cannot be described in detail here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01597908 · results posted 4 December 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01597908) enrolled 352 participants in each of two groups — one group received a combination of two medicines called dabrafenib plus trametinib, and the other received a single medicine called vemurafenib. A smaller third group of 34 people later crossed over to receive the combination after the main phase. The trial was measuring how long people lived overall, how long their disease took to worsen, how many people's tumours shrank or disappeared, and how long those responses lasted. The reported data shows that, for overall survival (the time from joining the trial until death from any cause), the median figure — meaning the point at which half the group had died and half had not — was reported as 26.0 months for the combination group and 17.8 months for the vemurafenib group. For progression-free survival (the time until the disease worsened or death occurred), the reported medians were 12.1 months for the combination group and 7.3 months for the vemurafenib group. Looking at tumour response, 68% of participants in the combination group and 53% in the vemurafenib group were reported to have had their tumours shrink or disappear. Among those who did respond, the reported median duration of that response was 13.8 months for the combination group and 8.5 months for the vemurafenib group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01387581 · results posted 14 November 2014

According to the results reported on ClinicalTrials.gov, this trial looked at a device called MelaFind, which analyses skin lesions to help identify possible melanomas (a type of serious skin cancer). The trial involved three groups of doctors examining skin lesions: one group of 108 dermatologists working without MelaFind, another group of 107 dermatologists working with MelaFind, and a smaller group of 12 expert dermatologists working without MelaFind. Of those who started, 101, 101, and 9 participants respectively completed the study. The trial measured two things: "sensitivity" (out of all the true melanomas present, what percentage were correctly flagged for biopsy or identified by the device) and "specificity" (out of all the lesions that were not melanoma, what percentage were correctly identified as not needing a biopsy). The reported data shows the following numbers for sensitivity: dermatologists working without MelaFind correctly flagged 69.5% of true melanomas for biopsy; dermatologists working with MelaFind flagged 78.0%; and the expert group without MelaFind flagged 71.8%. For specificity, the reported data shows that dermatologists without MelaFind correctly identified 55.9% of non-melanoma lesions as not needing a biopsy; dermatologists with MelaFind identified 45.8%; and the expert group identified 54.6%. These figures simply describe the percentages recorded during the trial — they do not on their own tell us whether any difference between the groups is meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00521053 · results posted 25 August 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people who had melanoma skin lesions. All 80 completed the treatment phase, during which participants received between one and four treatment cycles of PV-10 (a drug injected directly into melanoma lesions). The trial was primarily measuring how often the treated lesions visibly shrank or disappeared, and secondarily looking at what happened to nearby lesions that were *not* treated, how long it took before the disease got worse, and how many participants were still alive after one year. The reported data shows that, for the main measure, 51.3% of participants had their directly treated lesions shrink by at least 30% or disappear completely. For nearby lesions that were left untreated (sometimes called "bystander" lesions), 33.3% of participants saw those shrink or disappear as well. A separate after-the-fact analysis reported that 50% of participants whose lesions were all treated had every target lesion disappear entirely. For progression-free survival — meaning the time before the disease appeared to get worse — the reported figure was 3.7 months for Stage III participants and 1.9 months for Stage IV participants. Regarding one-year survival, the reported data shows 89% of Stage III participants and 39% of Stage IV participants were alive at the one-year mark. It is worth noting that 68 of the 80 participants did not complete the follow-up observation phase, which may affect how the longer-term figures are interpreted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00636168 · results posted 19 August 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT00636168) enrolled 951 people with melanoma — 475 randomly assigned to receive ipilimumab at a dose of 10 mg/kg and 476 assigned to receive a placebo (an inactive treatment). The trial was primarily measuring "recurrence-free survival" — that is, how long participants went without their melanoma coming back or without dying. It also measured how long participants went without the cancer spreading to distant parts of the body (called distant metastasis-free survival). The reported data shows that, for the main outcome, the median time before recurrence or death was 26.09 months in the ipilimumab group and 17.05 months in the placebo group. (Median means the point at which half the participants in each group had experienced an event and half had not.) In terms of actual numbers, 234 out of 471 participants in the ipilimumab group and 294 out of 474 in the placebo group experienced a recurrence or died during the study. Looking at specific time points, the reported data shows the percentage of participants who remained recurrence-free was: at 1 year, 63.5% (ipilimumab) versus 56.1% (placebo); at 2 years, 51.5% versus 43.8%; and at 3 years, 46.5% versus 34.8%. For the secondary outcome of distant metastasis-free survival, the median time was reported as 48.30 months in the ipilimumab group and 27.47 months in the placebo group, with 227 and 279 participants respectively experiencing a distant spread or death. The percentage free from distant spread at 1, 2, 3, 4, and 5 years was reported as 74.3%, 61.5%, 53.9%, 50.2%, and 48.3% for ipilimumab, compared with 65.8%, 53.3%, 45.2%, 41.5%, and 38.9% for placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01584648 · results posted 15 August 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 211 people in the dabrafenib plus trametinib group and 212 people in the dabrafenib plus placebo group — 423 participants in total. The trial was measuring how long people with a type of skin cancer (melanoma) went without their disease getting worse (called "progression-free survival"), as well as how long people lived overall, how many people's tumours shrank or disappeared, and how long those responses lasted. Blood levels of the study medicines were also measured. The reported data shows that, for the main measure — the time until the disease got worse or the person died — the dabrafenib plus trametinib group had a reported median (the midpoint value for the group) of 10.2 months, compared with 8.8 months for the dabrafenib plus placebo group. For overall survival, the reported median was 25.8 months in the combination group and 18.7 months in the placebo group. Regarding tumour shrinkage or disappearance, 146 out of 211 participants in the combination group and 113 out of 212 in the placebo group were reported to have had a confirmed response. Among those who responded, the reported median time before the disease got worse again was 12.9 months in the combination group and 10.2 months in the placebo group. The reported data also shows blood level measurements for the study medicines at various time points throughout the trial; these figures confirmed that trametinib was detected in participants taking the active combination but not in those taking the placebo, as would be expected. The dabrafenib blood level figures were broadly similar across both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01152788 · results posted 21 July 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01152788) involved 64 people with metastatic or recurrent malignant melanoma who had not previously received chemotherapy or immunotherapy. Participants were randomly assigned to receive either an experimental treatment called rIL-21 (32 people) or a standard chemotherapy drug called dacarbazine (32 people). The trial was primarily measuring "progression-free survival" — that is, how long participants went without their disease getting worse or dying. It also tracked response rates (how many participants' tumours shrank), overall survival (how long participants lived), and the number of participants who experienced serious side effects (graded 3, 4, or 5 — meaning significant, severe, or life-threatening). The reported data shows that the median progression-free survival — the point at which half the participants in each group had experienced disease progression or death — was 1.87 years in the rIL-21 group and 2.04 years in the dacarbazine group. For response rate, 13.3% of participants in the rIL-21 group and 14.3% in the dacarbazine group had their tumours shrink or disappear. The reported median overall survival was 6.6 months for the rIL-21 group and 7.3 months for the dacarbazine group. Regarding serious adverse events (significant or worse side effects), the reported data shows that 17 out of 32 participants in the rIL-21 group and 6 out of 32 participants in the dacarbazine group experienced at least one serious adverse event of this severity. It is worth noting that 4 participants in the dacarbazine group did not complete the study, while all 32 in the rIL-21 group did. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00864253 · results posted 5 June 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 529 people with melanoma — 264 assigned to receive a drug called ABI-007 (nab-paclitaxel) at a dose of 150 mg/m², and 265 assigned to receive a chemotherapy drug called dacarbazine at 1000 mg/m². The trial's main goal was to measure how long participants went without their disease getting worse (called "progression-free survival"), assessed by independent radiology reviewers. Secondary goals included measuring how long participants lived overall. The reported data shows that, for the primary measure of time without disease progression (based on independent radiology review), the median figure — meaning the point at which half the participants had experienced progression or death — was 4.8 months in the ABI-007 group and 2.5 months in the dacarbazine group. For overall survival (time from enrolment until death from any cause), the reported median was 12.8 months in the ABI-007 group and 10.7 months in the dacarbazine group. For the proportion of participants whose tumours shrank by at least 30% (a "partial response"), the reported data shows 15% in the ABI-007 group and 11% in the dacarbazine group; no participants in either group had a complete disappearance of their disease. Regarding "disease control" — meaning tumour shrinkage or stable disease lasting at least 16 weeks — 39% of the ABI-007 group and 27% of the dacarbazine group met that measure. Among the smaller group of participants whose tumours did respond, the reported median time that response lasted was 11.1 months in the ABI-007 group and 16.4 months in the dacarbazine group, though the data does not report how many participants were included in that specific calculation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01153763 · results posted 2 June 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 92 participants, all of whom received the study drug GSK2118436 (also known as dabrafenib) at a dose of 150 mg. Of those, 71 completed the trial and 21 did not. The trial was looking at how participants' tumours responded to the drug, focusing on two groups based on a specific gene change (mutation) in their tumour — either a BRAF V600E mutation or a BRAF V600K mutation. The main thing being measured was whether tumours shrank by a meaningful amount (called a complete or partial response), as well as how long it took for the disease to get worse and how long any tumour shrinkage lasted. The reported data shows that, among participants with the BRAF V600E mutation, 5 had a complete response (tumour disappeared entirely) and 40 had a partial response (tumour shrank by at least 30%). Among participants with the BRAF V600K mutation, 0 had a complete response and 2 had a partial response. The reported data also shows that the estimated median time before the disease got worse (called progression-free survival — that is, the midpoint of how long participants went without their disease worsening) was 6.3 weeks for the V600E group and 4.0 weeks for the V600K group. For those who did show a response, the median length of time that response lasted was reported as 6.6 weeks in the V600E group and 5.6 weeks in the V600K group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00324155 · results posted 10 March 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 502 people with melanoma — 250 in the ipilimumab plus dacarbazine group and 252 in the placebo plus dacarbazine group. The trial was measuring how long participants lived, how many showed signs of their disease being controlled or reduced, and how long any such responses lasted. The reported data shows that when looking at survival over time, 47.3% of participants in the ipilimumab-and-dacarbazine group were still alive at one year, compared with 36.3% in the placebo-and-dacarbazine group. At two years those figures were 28.5% and 17.9%, and at three years they were 20.8% and 12.2%. Regarding how many people's disease was controlled (meaning it shrank or stopped growing), the reported data shows 33.2% in the ipilimumab group and 30.2% in the placebo group met that measure. When looking only at participants whose disease clearly shrank (a partial or complete response), the reported figures were 15.2% in the ipilimumab group and 10.3% in the placebo group. For those who did have that kind of response, the reported median length of time their response lasted was 19.3 months in the ipilimumab group and 8.1 months in the placebo group. The median time before disease progressed was reported as approximately 2.76 months in the ipilimumab group and 2.60 months in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00920907 · results posted 6 March 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 75 participants in total — 37 received ipilimumab made using a manufacturing process called "Process B" and 38 received it made using "Process C." The trial was not testing whether the drug worked against a disease; instead, it was comparing how the body handles the drug depending on which manufacturing process was used to make it. Researchers tracked things like how much of the drug reached the bloodstream, how long it stayed there, and how quickly the body cleared it. Participants went through an induction period (four doses) and, for those who continued, a maintenance period. The reported data shows that the two versions of the drug behaved in very similar ways in the body. For the main measures, the peak level of the drug detected in the blood (the highest concentration reached after a dose) was reported as 252.68 micrograms per millilitre for Process B and 251.26 micrograms per millilitre for Process C. The total amount of drug the body was exposed to over the first 21 days was reported as 40,374.47 for Process B and 40,085.90 for Process C (measured in micrograms × hours per millilitre). For the supporting measures, the time it took to reach that peak level was 2.00 hours (Process B) and 2.50 hours (Process C). The time for half the drug to leave the body was about 15.45 days for Process B and 15.23 days for Process C. The rate at which the body cleared the drug was 12.59 mL/hour (Process B) and 12.93 mL/hour (Process C), and the space the drug distributed into in the body was 6.06 litres (Process B) and 5.96 litres (Process C). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01266967 · results posted 5 March 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 172 people with a type of skin cancer called melanoma that had spread to the brain, and which carried a specific gene change (mutation) linked to the cancer's growth. Participants were split into two groups: 89 people who had not previously received local treatment (such as surgery or radiation) to the brain, and 83 people who had. All participants received the study drug, GSK2118436 (also known as dabrafenib), at a dose of 150 mg. The trial's main goal was to measure how many people's brain tumours showed a meaningful reduction in size — what researchers call an "overall intracranial response." The reported data shows that, for the primary outcome (response of brain tumours in people with the V600E mutation type), 4 out of 89 participants in the no-prior-local-therapy group showed a complete disappearance of brain lesions, and 26 showed a significant reduction in size. In the prior-local-therapy group, 1 out of 83 showed complete disappearance and 23 showed a significant reduction. For the secondary outcomes looking at overall response across the whole body (brain and elsewhere combined, V600E mutation), 2 complete and 28 partial responses were reported in the no-prior-local-therapy group, and 0 complete and 23 partial responses in the prior-local-therapy group. For participants with a different mutation type (V600K), the numbers of responses were notably smaller across both groups. The reported data also shows that, among those whose brain tumours did respond, the response lasted a median (middle value) of around 24 weeks in the no-prior-local-therapy group and around 28 weeks in the prior-local-therapy group (for the V600E mutation group); duration figures for the V600K group were limited due to small numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01072175 · results posted 21 November 2013

According to the results reported on ClinicalTrials.gov, this trial (NCT01072175) tested different doses of two medicines — dabrafenib and trametinib — either alone or in combination, in people with a type of skin cancer called melanoma that carries a specific gene change (BRAF mutation). The trial was divided into four parts (A, B, C, and D), each with a different focus. In total, across all parts, several hundred participants took part: 8 in Part A, 150 in Part B (spread across four dose groups), 162 in Part C (including a randomised phase and a crossover phase where some participants switched treatments), and 110 in Part D. None of the groups were recorded as having formally "completed" the trial in the data submitted, which is not unusual for this type of cancer trial where participants continue treatment until their disease progresses or they withdraw. The reported data shows that Part A looked at how the body absorbs and processes dabrafenib when taken alone versus when taken alongside trametinib, by measuring drug levels in the blood. The peak blood concentration of dabrafenib alone was reported as around 509 nanograms per millilitre (ng/mL), compared with around 524 ng/mL when taken with trametinib — the figures were broadly similar across dabrafenib and its breakdown products. Part B recorded how many participants experienced any adverse event (an unexpected or unwanted medical occurrence) or serious adverse event across the different dose combinations. The reported data shows that all 6 participants in the lowest-dose combination group experienced at least one adverse event, as did all 23, all 27, and 93 out of 94 participants in the higher-dose groups respectively. Serious adverse events were reported in 1, 15, 14, and 55 participants across those same four groups. Part B also tracked changes in blood chemistry test results; notable worsening to severe or worse levels was reported for a small number of participants across the groups, with the largest number (10 out of 94) occurring in the highest-dose combination group for one particular chemistry measure. The results data for Parts C and D outcome measures were not fully reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00598507 · results posted 15 November 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 35 participants, all of whom completed the study. The trial was testing a chemotherapy drug called ZK-EPO (also known as sagopilone) in people with cancer, and it was measuring how their tumours responded to the treatment, as well as how long participants went without their disease getting worse and how long they survived overall. The reported data shows the following tumour responses among the 35 participants: 1 person had a complete response (meaning all detectable tumour signs disappeared), 2 had a partial response (meaning tumours shrank by at least 30%), 1 had stable disease (meaning the cancer neither shrank nor grew significantly), and 8 had progressive disease (meaning the cancer grew). The reported data shows that the median time before the disease progressed or death occurred — meaning the point at which half the participants had reached that outcome — was 7.5 weeks. The median overall survival was reported as 31 weeks. Regarding serious unwanted events judged to be related to the treatment and rated as severe (Grade 3 or higher), the reported number of participants experiencing these was 0, though it is worth noting that results for the remaining participants were not reported in the structured data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01106040 · results posted 3 June 2013

According to the results reported on ClinicalTrials.gov, 163 people took part in this trial, and 152 of them completed it. All participants received an injection of a radioactive tracing agent called Lymphoseek (also known as tilmanocept) as part of a lymphatic mapping procedure — a technique used during surgery to identify specific lymph nodes. The trial was measuring how well Lymphoseek and a standard blue dye tracked down the same lymph nodes during surgery, to see whether the two methods picked up the same nodes. The reported data shows two main results. First, looking at every lymph node that the blue dye found during surgery, Lymphoseek also found 100% of those same nodes (reported as a proportion of 1.0000). Second, when looking at it the other way around — every lymph node that Lymphoseek found — the blue dye also detected approximately 61% of those nodes (reported as a proportion of 0.6058). In other words, according to the reported figures, Lymphoseek appeared to find all the nodes the blue dye found, but the blue dye did not find all the nodes that Lymphoseek found. No other outcome data, such as side effects or longer-term follow-up results, was included in the data submitted to ClinicalTrials.gov for this summary. These numbers describe what was measured and counted in this particular group of trial participants, and may not reflect what would happen in any other situation or individual. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00450372 · results posted 1 May 2013

According to the results reported on ClinicalTrials.gov, 38 people took part in this single-arm trial (meaning everyone received the same treatment, with no comparison group), and 37 completed it. The trial tested a treatment called ADI-PEG 20 in people with a type of cancer. A key focus was whether a protein called Argininosuccinate Synthetase (ASS) — found in or absent from tumour cells — made a difference to how patients responded. Participants were grouped into those whose tumours had this protein present (ASS+) and those whose tumours did not (ASS−). The reported data shows that, for the main outcome — the number of participants whose tumours shrank or disappeared for at least 30 days — no participants in the ASS+ group had that response, while 4 participants in the ASS− group did. For survival, the reported median overall survival (the point at which half the participants in each group had passed away) was 9.3 months in the ASS+ group and 14.6 months in the ASS− group. The reported median time to progression (the point at which half the participants' cancer had grown or spread) was 1.8 months in the ASS+ group and 3.6 months in the ASS− group. These figures are as submitted to the registry; no further breakdown was reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00673361 · results posted 26 April 2013

According to the results reported on ClinicalTrials.gov, this trial (NCT00673361) enrolled 9 participants, all of whom received what was called a "Chemo-Switch" regimen — a particular approach to chemotherapy treatment. Of the 9 people who started the trial, 7 completed it, while 2 did not finish. The trial was designed to measure two things: how long participants went without their disease getting worse (called "progression free survival"), and how many participants showed a measurable reduction in their tumour according to a standard set of medical criteria known as RECIST. The reported data shows that the trial was stopped before it reached its intended number of participants. Because the trial ended early, no data analysis was carried out for the primary outcome — that is, the results on how long participants went without their disease progressing were not reported. Similarly, the secondary outcome looking at how many participants responded to treatment also has no numbers reported in the submitted data. In short, due to the trial closing before enough participants were enrolled, the results that were originally planned to be measured and reported are not available in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00096382 · results posted 27 March 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people in total. They were split into two groups based on whether they had previously received a treatment called IL-2: 23 participants had prior IL-2 treatment and 3 had not. All participants received a combination treatment involving low-dose whole-body radiation (called TBI at 200cGy), a type of immune cell infusion known as TIL (tumour-infiltrating lymphocytes), and high-dose IL-2. The trial was measuring two things: how many participants' tumours shrank or disappeared, and how many participants experienced unwanted side effects (adverse events). The reported data shows that, when it came to tumour response, the results were broken down into two categories. In the group that had prior IL-2 treatment (23 people), 1 person showed a complete response (all measurable tumours disappeared) and 9 showed a partial response (tumours shrank by at least 30%). In the smaller group with no prior IL-2 treatment (3 people), 1 showed a complete response and 2 showed a partial response. Regarding adverse events, the reported data shows that all 26 participants — all 23 in the prior IL-2 group and all 3 in the no prior IL-2 group — experienced at least one adverse event. The trial record notes that a detailed breakdown of those adverse events is listed separately in the full trial record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01245062 · results posted 15 March 2013

According to the results reported on ClinicalTrials.gov, this trial (NCT01245062) enrolled 322 participants with advanced melanoma. Of these, 214 were randomly assigned to receive trametinib (a targeted medicine) and 108 were assigned to receive standard chemotherapy. After completing the chemotherapy phase, 70 participants crossed over to receive trametinib instead. The trial was primarily measuring "progression-free survival" — that is, how long participants went without their cancer getting worse or dying — in those whose tumours carried a specific gene change called BRAF V600E and who had no prior history of cancer spreading to the brain. The reported data shows that, for the primary measure in that specific group, the median time without disease worsening was 4.8 months in the trametinib group compared with 1.4 months in the chemotherapy group, based on doctors' assessments; a separate independent review reported similar figures of 4.9 months versus 1.6 months. (Median means half of participants in each group reached that point sooner, and half later.) For all participants regardless of their cancer's gene status, the reported median progression-free survival was 4.9 months for trametinib and 1.5 months for chemotherapy. The reported data also shows median overall survival — how long participants lived from the start of the trial — was 15.6 months in the trametinib group and 11.3 months in the chemotherapy group across all participants; overall survival figures for the BRAF V600E-positive subgroup without brain metastases were not available in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00110019 · results posted 27 September 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 823 people in total — 410 in the group receiving carboplatin, paclitaxel, and sorafenib (three medicines combined), and 413 in the group receiving carboplatin and paclitaxel only (with a placebo standing in for the third medicine). The trial was measuring how long participants lived overall, how long they lived before their disease got worse, and how many showed a measurable shrinkage in their tumour. The reported data shows that for overall survival — meaning the time from when someone joined the study until death from any cause — the three-medicine group had a median (that is, the midpoint value for the group) of 11.1 months, compared with 11.3 months in the two-medicine group. For progression-free survival — meaning the time until the disease got worse or death occurred, whichever came first — the reported median was 4.9 months in the three-medicine group and 4.2 months in the two-medicine group. For tumour response, the reported data shows that approximately 20.5% of people in the three-medicine group had their tumour shrink or disappear, compared with approximately 18.2% in the two-medicine group. It is worth noting that very few participants were recorded as having "completed" the study in the way the trial defined completion — 4 in the three-medicine group and none in the two-medicine group — though the reasons behind this figure were not detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00006237 · results posted 19 September 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 212 people in the Interferon group and 220 people in the Biochemotherapy group — a total of 432 participants. The trial was comparing two different treatment approaches for what appears to be a cancer (most likely melanoma, based on the treatments involved). The main things the trial was measuring were how many participants were still alive after five years, and how many had gone that long without their disease coming back or getting worse. The trial also tracked certain unwanted side effects classed as moderate-to-severe (Grade 3–5). The reported data shows that for five-year overall survival (the proportion of people still alive at the five-year mark), both groups recorded the same figure: 56% in the Interferon group and 56% in the Biochemotherapy group. For five-year relapse-free survival (the proportion of people who had not seen their disease return or worsen by five years), the reported figures were 47% for the Interferon group and 38% for the Biochemotherapy group. Regarding the secondary outcome of moderate-to-severe side effects related to the study treatments, the reported data shows small numbers of participants in each group experienced various specific types of these events (ranging from 0 to 3 participants per event type per group); however, the full breakdown by individual event type was not accompanied by event labels in the data provided, so a more detailed description cannot be given. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00707161 · results posted 4 April 2012

According to the results reported on ClinicalTrials.gov, this trial (NCT00707161) enrolled 6 participants, all of whom were in a single treatment group receiving a combination of radiation therapy and cisplatin (a type of chemotherapy drug). The trial was set up to measure the response rate of melanoma lesions — that is, how the melanoma spots changed after treatment. Notably, the reported data shows that none of the 6 participants completed the study, with all 6 listed as having not completed it. No reason for this is provided in the submitted data. The reported data shows that no measurements were recorded for the primary outcome measure — the response rate of melanoma lesions. In other words, the actual results for this key measurement were not reported on ClinicalTrials.gov. Because all participants left the study before it was finished and no outcome numbers were submitted, there is no data available from this trial to describe what happened to the melanoma lesions in those who took part. There were also no secondary outcome measures listed or reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00841204 · results posted 16 March 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people in total — 25 who took a medicine called sulindac and 25 who took a placebo (a dummy pill with no active ingredient). All 50 participants completed the study. The trial was looking at whether sulindac, taken by mouth, would actually reach atypical moles (also called nevi) in the skin, and at certain biological markers measured in those moles before and after treatment. The reported data shows that in the sulindac group, the drug and two of its breakdown products (called metabolites) were detected in mole tissue samples. Sulindac itself was measured at 0.51 micrograms per gram of tissue, while the two metabolites — sulindac sulfone and sulindac sulfide — were measured at 1.38 and 0.12 micrograms per gram of tissue respectively. As expected, none of these substances were detected in the placebo group (all recorded as 0). For the secondary measurements, the reported data shows a change in a cell-death marker (cleaved caspase 3) of +3 units in the sulindac group and −25 units in the placebo group. A marker related to blood vessel growth (VEGF) changed by +23 units in the sulindac group and 0 units in the placebo group. The trial also looked at how closely levels of sulindac in the blood matched levels found in the mole tissue, reporting a correlation figure of 0.41 (a number between 0 and 1 that describes how closely two measurements track together). No secondary measurement data was reported separately for the placebo group in that last analysis. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00949702 · results posted 22 December 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 132 people, all of whom received vemurafenib at a dose of 960 mg. Of those, 84 completed the study and 48 did not. The trial was measuring how well vemurafenib reduced tumours in participants, using a standardised set of rules called RECIST 1.1 to judge whether tumours had shrunk, stayed the same, or grown. The main thing being measured was whether participants had a "best overall response" — meaning their tumours either disappeared completely or shrank by at least 30% and stayed that way. The reported data shows that, according to an independent review committee, 52.3% of participants had their tumours shrink enough to meet the criteria for a response. When the treating doctors (investigators) made the same assessment themselves, the reported figure was 54.5%. Among those whose tumours did respond, the reported data shows the response lasted a median (middle value) of 6.5 months. The time from starting treatment to when a response was first recorded was reported as a median of approximately 1.4 months. The reported data also shows that the median time before the disease progressed or death occurred — known as progression-free survival — was 6.1 months. For overall survival (time from starting treatment to death from any cause), the data was not reported as a usable number in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01006980 · results posted 16 November 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 337 people in the vemurafenib group and 338 people in the dacarbazine group — a total of 675 participants. Both are treatments for a type of skin cancer. The trial was primarily measuring two things: how long participants lived overall (called "overall survival"), and how long they lived without their disease getting worse (called "progression-free survival"). A separate crossover phase allowed 84 people who had been in the dacarbazine group to later receive vemurafenib. The reported data shows that, for overall survival, 43 out of 337 participants in the vemurafenib group experienced a death during the study period, compared with 75 out of 338 in the dacarbazine group. For progression-free survival — meaning their disease got worse or they died — the reported numbers were 104 out of 337 in the vemurafenib group and 182 out of 338 in the dacarbazine group. For a secondary measure looking at tumour shrinkage (either complete or partial), 106 out of 337 participants in the vemurafenib group showed a qualifying response, compared with 12 out of 338 in the dacarbazine group. Among those who did respond, the reported data shows the average duration of that response in the vemurafenib group was approximately 5.49 months; a comparable figure for the dacarbazine group was not reported. The time from the start of treatment until a confirmed response was recorded as approximately 1.45 months for vemurafenib and 2.72 months for dacarbazine. The "time to treatment failure" outcome was listed in the trial plan but, according to the reported data, no analysis of that measure was carried out. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00111007 · results posted 23 February 2011

According to the results reported on ClinicalTrials.gov, this trial (NCT00111007) enrolled 135 participants in each of two groups — one group received a medicine called sorafenib (also known as Nexavar or BAY43-9006), and the other received a combination chemotherapy called carboplatin/paclitaxel. The trial was primarily measuring how long participants went without their disease getting worse (called "progression-free survival"), and also tracked how long participants lived overall, how long before the disease progressed, how long any response to treatment lasted, and changes in participants' general physical functioning during the study. The reported data shows that for the main outcome — the number of days from the start of the study until the disease worsened or a participant died — the median figure was 122 days in the sorafenib group and 125 days in the carboplatin/paclitaxel group. For overall survival (how long participants lived from the start of the study), the reported median was 294 days in both groups. The time until the disease specifically progressed (not counting deaths before progression) was reported as 126 days in both groups. For participants who showed a measurable response to treatment, the reported data shows that response lasted a median of 228 days in the sorafenib group and 166 days in the carboplatin/paclitaxel group. Regarding participants' physical functioning scores at the point of their best response, the reported data shows mixed results across the two groups, with some participants improving, some staying the same, and some worsening. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.