Reported trial results for Bladder Cancer

Every Bladder Cancer 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.

73 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

NCT03924895 · results posted 30 June 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT03924895) enrolled a total of 595 people with muscle-invasive bladder cancer across three groups: 166 people received pembrolizumab (an immunotherapy medicine) followed by surgery (Arm A); 259 people had surgery alone (Arm B); and 170 people received a combination of two medicines — enfortumab vedotin and pembrolizumab — followed by surgery (Arm C). The trial was primarily measuring "event-free survival," which refers to how long participants went without their disease getting worse, without being unable to have surgery, or without dying. It also looked at whether tumours had completely disappeared by the time of surgery, which is called a "pathologic complete response." The reported data shows that for the main comparison — Arm C (the two-medicine combination plus surgery) versus Arm B (surgery alone) — the median event-free survival for the surgery-alone group (Arm B) was reported as 15.7 months. The figure for Arm C was listed as "NA" (not available or not yet reached), meaning a median could not be calculated from the data as submitted. For the secondary measure looking at pathologic complete response — that is, no detectable tumour remaining at the time of surgery — the reported data shows that 8.6% of participants in the surgery-alone group (Arm B) had a complete pathologic response, compared with 57.1% of participants in the Arm C combination-therapy group. The outcome data for Arm A (pembrolizumab plus surgery) comparisons, as well as overall survival figures for all arms, were 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 ↗
NCT04822350 · results posted 2 April 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 596 participants, all of whom were included in the overall study count with no participants recorded as having left the study early. A slightly smaller group of 589 people were included in the main analysis set. The trial was measuring how long participants lived after starting treatment with a medicine called avelumab — a type of immunotherapy — which was given as a maintenance (ongoing) treatment after chemotherapy for bladder and urinary tract cancer. The study also looked at how long it took before the cancer showed signs of growing or spreading again. The reported data shows that, overall, the middle point for how long participants lived after their first avelumab injection — known as median overall survival — was 21.3 months. When participants were grouped by the specific type of cancer they had, the reported figures were 22.1 months for those with pure urothelial carcinoma (the most common bladder cancer type), 20.0 months for those with a pure variant type, and 17.2 months for those with a mixed urothelial and variant type. When survival was counted from the start of their earlier chemotherapy rather than from avelumab, the overall figure was 24.5 months. For how long it took before the cancer progressed or participants died — called progression-free survival — the reported overall figure was 5.7 months, with results by cancer subtype ranging from 4.3 to 7.2 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.

View reported results on ClinicalTrials.gov ↗
NCT04055311 · results posted 19 March 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT04055311) involved people who had undergone surgery to remove the bladder due to cancer, along with their caregivers. In total, 174 people started the trial — 47 bladder cancer survivors and 31 caregivers in the intervention group, and 62 survivors and 34 caregivers in a comparison group called "usual care enhanced." The trial tracked participants over 12 months (at 1, 3, 6, and 12 months), and by the end, 28 intervention survivors, 16 intervention caregivers, 38 usual care enhanced survivors, and 26 usual care enhanced caregivers had completed all follow-up points. The trial was measuring quality of life for both survivors and caregivers at multiple time points. The reported data shows that survivor quality of life was measured using a questionnaire called the FACT-BL-CYS, which produces a total score out of 168 — a higher number means better quality of life as reported on that scale. According to the results reported on ClinicalTrials.gov, the scores across the five time points for intervention survivors were approximately 117.6, 116.3, 127.5, 129.7, and 130.5, while for usual care enhanced survivors the corresponding scores were approximately 118.7, 106.8, 120.0, 121.3, and 123.2. For caregivers, quality of life was measured using a different questionnaire scored out of 48 (again, higher means better). The reported data shows one set of caregiver figures — intervention caregivers scored approximately 34.3 and usual care enhanced caregivers scored approximately 33.2, though it is not clear from the submitted data at which time point this caregiver measurement was taken. 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 ↗
NCT04165317 · results posted 22 January 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT04165317) enrolled 1,068 participants across five groups. Three of those groups made up the main comparison (Cohort A), each with around 350 people, and two smaller groups (Cohort B1 and B2) had 5 and 8 participants respectively. The trial was looking at a drug called PF-06801591 (sasanlimab) given alone or alongside BCG — a long-established bladder treatment — in people with a type of bladder cancer that had not yet grown into the muscle wall. The main thing being measured was "event-free survival," meaning how long people went without their cancer coming back in a serious way, getting worse, or dying. The reported data shows that for the primary measure — comparing the combination of PF-06801591 plus BCG (with both induction and maintenance phases) against BCG alone — a median event-free survival figure was not reported (recorded as "NA"), meaning the data had not reached a point where a middle value could be calculated at the time of reporting. For the secondary comparison of PF-06801591 plus BCG (induction only) versus BCG alone, the reported median event-free survival was 50.1 months for the PF-06801591 group, while the BCG-alone figure was again not reported. Figures for overall survival (how long people lived) were not reported in the submitted data for either comparison. For participants who had a specific type of cancer called carcinoma in situ (CIS) at the start of the trial, the percentage who achieved a "complete response" (no detectable cancer) was reported as approximately 89.8% in Arm A, 88.2% in Arm B, and 85.2% in the BCG-alone group. The duration of that complete response was reported as a median of 44.6 months for Arm B, while the figures for Arm A and the BCG-alone group had not yet reached a calculable midpoint 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.

Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT03747419 · results posted 31 October 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 14 participants, and all 14 completed the study. The trial was looking at a combination of a drug called avelumab (a type of immunotherapy) and radiation therapy directed at the bladder. The main thing researchers were measuring was whether participants showed a "complete clinical response" — meaning no sign of disease on a camera inspection of the bladder (cystoscopy), a urine test, and a body scan — at three months after finishing radiation, with further checks continuing for up to three years. The reported data shows that, for the primary measure of complete clinical response, the numbers recorded across different time points were 5, 3, and 4 participants respectively (out of 14). For the secondary outcomes, the reported data shows: for overall survival, participant counts across categories were 5, 2, 4, and 1; for both progression-free survival (how long participants went without the disease getting worse) and metastases-free survival (how long participants went without the disease spreading), the reported counts were 5 and 7 participants across categories; and for locoregional recurrence (disease returning in or near the original area), the counts were 1 and 11 participants across categories. The trial also collected quality-of-life scores using a 0–4 questionnaire scale at various time points — covering things like diarrhoea, urinary symptoms, and general wellbeing — and the reported median scores ranged from 0 to 3 across the different questions and time points. Full context for how these participant counts map to specific outcomes (such as "alive" vs "deceased") 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.

View reported results on ClinicalTrials.gov ↗
NCT01382706 · results posted 9 October 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT01382706) enrolled 15 participants, all of whom were in a single treatment group. Of those, 13 completed the study and 2 did not. The trial was looking at two things: how long participants went without their condition getting worse (called "progression-free survival"), and how often serious unwanted medical events of a certain severity occurred. The reported data shows that the median progression-free survival — that is, the midpoint estimate for how long participants went before their condition progressed or they passed away — was 1.4 months. To put it simply, this is the point at which roughly half of participants had experienced progression or death and half had not. The reported data also shows that there were 22 serious unwanted medical events recorded that were graded as "Grade 3 or higher," meaning they were considered severe or worse according to a standard medical grading scale. It is worth noting that the data does not break down which specific events these were or how they were distributed among 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.

View reported results on ClinicalTrials.gov ↗
NCT04149574 · results posted 16 September 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04149574) enrolled 12 participants in total — 8 in Arm A and 4 in Arm B. All 12 participants completed the study, with none recorded as dropping out. The trial was designed to investigate treatments for a form of bladder cancer, and it was structured in two parts. The main things it set out to measure in Part 2 included how long participants went without their disease coming back or worsening (called "event-free survival"), how long they lived overall, and whether the disease had cleared up at a 13-week check. The reported data shows that for nearly all of the planned outcome measures — including event-free survival, worsening-free survival, overall survival, complete response rate at 13 weeks, and duration of response — no results figures were provided. These outcomes were all marked as "Data Not Collected," meaning the numbers were not reported to ClinicalTrials.gov. The only outcome with reported numbers was a count of participants who stopped taking the study treatment due to any adverse event (an unexpected medical occurrence during the trial). The reported data shows that in Arm A, 1 out of 8 participants discontinued for this reason, while in Arm B, 3 out of 4 participants did. No further breakdown of those events was reported in the submitted data. Because the main outcomes were not collected or reported, the trial's central questions about how long participants remained disease-free cannot be answered from 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.

View reported results on ClinicalTrials.gov ↗
NCT04172675 · results posted 1 August 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04172675) enrolled 107 participants across four groups studying a drug called erdafitinib in people with bladder cancer. The largest group — 49 people — received erdafitinib and was compared against a group of 24 people who received a treatment of their doctor's choice (Cohort 1). A further 16 people received erdafitinib in a second group (Cohort 2), and 18 people received it in a third group (Cohort 3). Nine participants from the doctor's-choice group later crossed over to receive erdafitinib. The trial was primarily measuring "recurrence-free survival" — meaning how long participants went without their bladder cancer coming back or dying — and also tracked several other things including how far the disease progressed, overall survival, unwanted medical events, and drug levels in the blood. The reported data shows that for the primary outcome — recurrence-free survival — the median time (the point at which half the participants had experienced a recurrence or death) was reported as 11.60 months for the doctor's-choice group. For the erdafitinib group, this figure was listed as "NA," meaning the median had not been reached by the time the data was collected, so a final number was not reported. For a related secondary measure, the proportion of participants who remained recurrence-free at 6 months was reported as 0.96 (roughly 96 in every 100) in the erdafitinib group and 0.73 (roughly 73 in every 100) in the doctor's-choice group. At 12 months, those proportions were reported as 0.79 and 0.44 respectively. Median time-to-progression and overall survival figures were listed as "NA" for both Cohort 1 groups, meaning those endpoints had not been reached at the time of reporting. The reported data also shows that all 49 treated participants in the erdafitinib arm of Cohort 1, all 19 treated participants in the doctor's-choice arm, all 16 in Cohort 2, and all 18 in Cohort 3 had at least one treatment-emergent adverse event recorded — that is, an unwanted medical occurrence noted during or shortly after treatment. Blood levels of erdafitinib were also measured across the erdafitinib groups, with figures ranging from roughly 525 to 750 nanograms per millilitre depending on the group and time of measurement; these are simply measurements of how much drug was present in participants' blood and do not on their own indicate anything about benefit or harm. 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 ↗
NCT03732677 · results posted 3 July 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03732677) enrolled 1,063 people with bladder cancer — 533 in the group receiving durvalumab combined with gemcitabine and cisplatin (chemotherapy), and 530 in the group receiving gemcitabine and cisplatin alone. The trial was primarily measuring two things: how many participants showed no detectable cancer in the bladder when it was surgically removed (called a "pathologic complete response"), and how long participants went without their disease coming back or worsening after they joined the trial (called "event-free survival"). The reported data shows that, of those assessed at the time of surgery, 199 participants in the durvalumab-plus-chemotherapy group and 146 participants in the chemotherapy-only group showed no remaining cancer at surgery. For event-free survival, the median time — meaning the point at which half the group had experienced a disease event — was not yet reached in the durvalumab-plus-chemotherapy group, while it was reported as 46.1 months in the chemotherapy-only group. For a related secondary measure looking at how many participants remained event-free at the two-year mark, the reported figures were 67.8% in the durvalumab-plus-chemotherapy group and 59.8% in the chemotherapy-only group. The reported data shows that 469 and 441 participants respectively went on to have their bladder surgically removed. For overall survival and metastasis-free survival (the time until cancer spread to other parts of the body), the median figures were not yet available for either group at the time this data was reported — meaning not enough events had occurred to calculate those 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT02122172 · results posted 25 April 2025

According to the results reported on ClinicalTrials.gov, 32 people took part in this trial of a drug called afatinib. All 32 participants were recorded as having completed the study. The group was split into two sub-groups: 23 people in a main Phase II study and 9 people in a separate "molecularly selected" cohort (meaning they were chosen based on specific features of their cancer cells). The trial was primarily measuring how many participants went for at least 3 months without their cancer growing or spreading — a period known as "progression-free survival." The reported data shows that, of the 32 participants, 5 were free from disease progression at the 3-month mark, which was the main outcome being tracked. Looking at secondary (additional) outcomes, the reported data shows that 2 participants had their tumours shrink to a meaningful degree (what the trial called an "overall response" — either the tumour disappearing entirely or reducing in size by at least 30%). The midpoint time before disease progression across participants was reported as 1.4 months, and the midpoint survival time overall was reported as 5.3 months. Separately, tissue samples were tested for specific genetic features: 5 participants showed amplification (extra copies) of a gene called EGFR, and 4 showed amplification of a gene called HER2. 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 ↗
NCT04586244 · results posted 10 March 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people across five treatment groups, all receiving different combinations of investigational medicines before surgery for bladder cancer. The five groups were: epacadostat plus retifanlimab (3 people); retifanlimab alone (20 people); epacadostat alone (2 people); retifanlimab plus a medicine called INCAGN02385 (4 people); and a three-medicine combination adding INCAGN02390 to that last group (1 person). The trial was primarily measuring changes in a type of immune cell — called CD8+ lymphocytes — inside the tumour tissue removed during surgery, as a way of tracking how the tumour's immune environment may have shifted after treatment. The reported data shows that for the primary outcome (the change in CD8+ immune cells in tumour tissue), meaningful data could only be reported for the retifanlimab-alone group, where the result was 0.791 on a technical scale used to measure the size of the change. The researchers noted that data from all other groups was too limited to assess this measure. For the secondary outcomes, the reported data shows that across all groups, the number of participants who experienced any side effect that emerged during treatment was: 3 out of 3 (epacadostat + retifanlimab), 18 out of 20 (retifanlimab alone), 2 out of 2 (epacadostat alone), 4 out of 4 (retifanlimab + INCAGN02385), and 1 out of 1 (the three-medicine group). More serious side effects (rated Grade 3 or higher — meaning severe, life-threatening, or fatal) were reported in 2, 9, 0, 2, and 1 participants in those same groups respectively. The reported data also shows figures for tumour response after surgery. The percentage of participants whose surgically removed tissue showed no detectable remaining cancer (called a "pathological complete response") was reported as 100% in the epacadostat + retifanlimab group, 40% in the retifanlimab-alone group, 0% in the epacadostat-alone group, 0% in the retifanlimab + INCAGN02385 group, and 100% in the three-medicine group. It is important to note that most of these groups contained very few people (as few as one or two), which means these percentages should be understood with great caution. The "major pathological response" figures — a slightly broader measure of tumour reduction — were reported as 100%, 50%, 50%, 50%, and 100% across the same 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.

View reported results on ClinicalTrials.gov ↗
NCT02662062 · results posted 27 January 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 28 participants, all of whom received a treatment called pembrolizumab (an immunotherapy drug) alongside chemotherapy and radiation. The trial was investigating a combination treatment for bladder cancer. Of the 28 people who started, 27 completed the study. The trial was primarily looking at how many participants experienced what the researchers defined as an "unacceptable" level of serious side effects or treatment disruptions — for example, severe reactions, having to miss doses of chemotherapy, or radiation taking longer than planned. The reported data shows that, across several predefined categories of unacceptable toxicity, the numbers of participants who met each category were 9, 6, 2, 4, 2, and 1 respectively. Because the data does not include labels clearly matching each number to a specific category, the exact breakdown cannot be stated with certainty here. On the secondary measures, the reported data shows that 90% of evaluable participants had no detectable tumour at around 12 weeks after finishing chemoradiotherapy, and 88% still had no detectable tumour at around 24 weeks after finishing treatment. These assessments involved physical examination, biopsies, and scans. The reported data also shows that 92% of evaluable participants were still alive at 12 months from the start of the study, and 85% had not developed cancer spread to distant parts of the body by that same point. The estimated median overall survival — meaning the point at which half the group was still alive — was reported as 39 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04314778 · results posted 24 December 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04314778) involved 61 people in total — 30 in the intervention group and 31 in a control group (who did not receive the intervention). Of those, 25 and 28 people respectively completed the study. The trial was measuring physical activity levels after surgery, specifically tracking daily step counts using a step-counting device. The main question was whether the intervention changed how much participants walked — first while still in hospital after surgery, and then again at three months after being discharged home. The reported data shows that, for the primary outcome — the change in average daily steps from just after surgery to the time of leaving hospital — the intervention group recorded a mean (average) increase of 1,087 steps per day, while the control group recorded a mean increase of 995 steps per day. For the secondary outcome — the change in average daily steps from just after surgery to three months after discharge — the intervention group recorded a mean increase of 5,674 steps per day, while the control group recorded a mean increase of 4,660 steps per day. These are the differences in step counts reported at each time point between the two groups. The reported data also notes that several other outcomes were planned to be measured — including rates of transfer to a nursing facility, hospital readmission within 90 days, complications after surgery, and confusion (delirium) after surgery — however, no numbers for these outcomes were included in the data submitted to ClinicalTrials.gov, so those figures are not available to report 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.

View reported results on ClinicalTrials.gov ↗
NCT03702179 · results posted 5 December 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 32 people, all of whom received a combination of two immunotherapy medicines called durvalumab and tremelimumab, alongside radiotherapy, for muscle-invasive bladder cancer. All 32 participants completed the study. The trial was primarily looking at how many people showed a "pathological response" — meaning that after treatment, a biopsy (tissue sample) of the bladder showed no remaining muscle-invasive cancer. The reported data shows that, for the primary measure, 26 out of 32 participants showed this pathological response (no muscle-invasive cancer found on biopsy), while 2 did not. Note that the data as submitted lists two separate figures for this outcome but does not clearly label what each figure represents beyond those counts, so the remaining participants' status is not fully explained in the submitted data. For the secondary measures, 28 out of 32 participants had their bladder preserved (kept in place) following assessment, while 0 did not meet that outcome. The reported data shows that 1 participant required an immediate surgical removal of the bladder (called a salvage cystectomy) after the first check, and 2 required this surgery at a later follow-up check. Looking further out, the reported data shows that an estimated 65% of participants were free from the need for bladder removal or return of muscle-invasive cancer or spread of cancer at 24 months. Additionally, an estimated 71.4% of participants were free from tumour return or spread (without needing bladder removal surgery) at 24 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.

View reported results on ClinicalTrials.gov ↗
NCT01224665 · results posted 29 November 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 592 people with muscle-invasive bladder cancer who were having surgery to remove the bladder (called a radical cystectomy). Participants were randomly split into two groups: 300 received a standard lymph node removal (where nearby lymph nodes are taken out to check for cancer spread), and 292 received an extended lymph node removal (where a larger area of lymph nodes was removed). The trial was measuring whether removing more lymph nodes made a difference to how long people lived without their cancer coming back, and how long they lived overall. The reported data shows that over five years, 60% of people in the standard lymph node removal group were free from cancer recurrence (their cancer had not come back), compared with 56% in the extended removal group. For overall survival at five years, 63% of the standard group were still alive, compared with 59% in the extended group. The reported data also shows that surgery took a median (middle value) of 5.3 hours in the standard group and 5.9 hours in the extended group, and that the typical hospital stay afterwards was 6 days for the standard group and 7 days for the extended group. In terms of lymph nodes removed, the median total number was 24 in the standard group and 39 in the extended group, with a median of 1 positive (cancer-containing) lymph node in the standard group and 2 in the extended 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT02619253 · results posted 18 November 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 52 people across five groups. There were two smaller "dose-finding" groups (4 people each) used to work out a safe dosing level for the combination of two drugs — vorinostat and pembrolizumab. The remaining 44 people were split across three "expansion" groups (roughly 14–15 people each), made up of different cancer types. The trial was primarily measuring how many participants' tumours shrank or disappeared, and how long participants went without their disease getting worse. The reported data shows that, looking at tumour shrinkage across the three expansion groups, the percentage of participants whose tumours shrank or disappeared was 7.7% in Expansion Group A, 0% in Expansion Group B, and 16.7% in Expansion Group C. For how long participants went without their condition getting worse (called "progression-free survival" — meaning the time from starting treatment until the disease progressed or the person passed away), the reported median times were 2.9 months for Group A and 3.5 months for both Groups B and C. Regarding serious side effects (grade 3 or 4, meaning significant or severe reactions considered related to treatment), the reported data shows that 0 participants in the two dose-finding groups, 5 in Group A, 3 in Group B, and 5 in Group C experienced these. No dose-limiting reactions — reactions serious enough to require stopping or changing the dose — were recorded in the dose-finding phase. Only 1 out of the 52 participants was recorded as having completed 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT05012397 · results posted 17 October 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people who all had advanced or metastatic solid tumours (cancers that had spread) carrying a specific genetic change called MDM2 gene amplification. All 40 participants received the study drug, milademetan (also called RAIN-32). By the time the trial ended, 14 participants had completed the study and 26 had not completed it. The trial was primarily measuring how often the drug caused tumours to shrink or disappear — known as the "overall response rate" — and also tracked several secondary measures related to how long any response lasted and how long people went without their cancer getting worse. The reported data shows that the overall response rate — meaning the proportion of participants whose tumours shrank significantly (a partial or complete response) — was 3.2%, which represented a very small number of the 40 participants. For the secondary measures, the reported data shows that among those who did respond, the duration of that response was approximately 3.84 months. The time from starting the drug until the cancer progressed or the participant died (called progression-free survival) was reported as 3.5 months on average. A measure called the Growth Modulation Index — which compares how long the cancer took to worsen on this drug versus the previous treatment — was reported as 0.76. Finally, the disease control rate, meaning the percentage of participants whose cancer either responded or remained stable for at least 16 weeks, was reported as 22.6%. 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 ↗
NCT04548193 · results posted 28 August 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04548193) enrolled 49 people in total — 25 in the experimental group (Arm A) and 24 in the control group (Arm B). The trial was measuring whether people in the experimental group changed how much cruciferous vegetables (such as broccoli, cabbage, and cauliflower) they ate, and whether that change showed up in their urine levels of a natural compound called isothiocyanates (a substance found in these vegetables that can be detected as a marker of intake). The study also looked at changes in gene activity as a secondary measure. The reported data shows that, by the end of the study, the experimental group had an average change in urinary isothiocyanate levels of 10.4 mM (millimoles, a unit of chemical concentration), compared with 4.3 mM in the control group. For cruciferous vegetable intake measured by questionnaire, the reported average change was 0.78 cups per day in the experimental group versus 0.058 cups per day in the control group. A separate dietary recall method (where trained staff interviewed participants about what they actually ate) showed a reported average change of 1.01 cups per day in the experimental group compared with 0.07 cups per day in the control group. For the secondary outcome of gene expression (activity of genes in the body), the reported data shows no numerical results were submitted to ClinicalTrials.gov — 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.

View reported results on ClinicalTrials.gov ↗
NCT02554812 · results posted 30 July 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT02554812) enrolled a total of 457 participants across 27 different treatment groups. It tested several different combinations of investigational medicines — including avelumab, utomilumab, PF-04518600, PD-0360324, and CMP-001 — in people with various types of cancer, including non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, triple-negative breast cancer, and small cell lung cancer. The trial had two main stages: an early "Phase 1b" stage focused on finding out whether the drug combinations caused certain serious reactions at specific doses, and a later "Phase 2" stage that looked at how tumours responded. No participants were recorded as having formally "completed" the study, with all participants listed under "not completed." The reported data shows that for the primary focus of the Phase 1b stage — counting how many participants experienced what researchers defined as a "dose-limiting toxicity" (meaning a serious adverse reaction severe enough to limit the dose) during the first one or two treatment cycles — the numbers were very low across most groups. For the combinations labelled A, B, and C, zero out of all participants in each dose group met the criteria for a dose-limiting toxicity. For Combination D (a three-drug combination), the reported data shows 1 participant in one group, 2 participants in another, and 1 in a third group experienced a dose-limiting toxicity, while other groups in that combination reported zero. The reported data for Combination F and the full secondary outcome results (such as tumour response rates) were not completely included in the data provided, so those figures 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.

Read the full trial page · View reported results on ClinicalTrials.gov ↗
NCT01489813 · results posted 25 July 2024

According to the results reported on ClinicalTrials.gov, this trial involved 36 men in total — 16 in a sugar pill (placebo) group and 20 in a genistein supplement group. Genistein is a naturally occurring compound found in soy. The trial was measuring changes in urinary symptoms over 6 weeks, using a standard questionnaire called the International Prostate Symptom Score (IPSS). This questionnaire gives a score between 0 and 35, where a lower score means fewer or less bothersome urinary symptoms. The trial also looked at whether cancer was detected at a biopsy done around 10 weeks into the study. By the end of the trial, 13 participants in the sugar pill group and 17 in the genistein group had completed the study, with 3 people in each group not finishing. The reported data shows that, on average, IPSS scores changed by minus 2 points in the sugar pill group and minus 3 points in the genistein group over the 6-week period — meaning both groups reported a small reduction in urinary symptom scores from their starting point. The reported data shows that at the 10-week biopsy, cancer was detected in 7 out of 13 participants in the sugar pill group and in 10 out of 17 participants in the genistein group. These are simply the numbers recorded — the trial does not draw conclusions about what caused these results, and no comparison or interpretation beyond the raw figures was 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.

View reported results on ClinicalTrials.gov ↗
NCT04209114 · results posted 27 June 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04209114) involved 114 people with bladder cancer who were split into three groups: one group received a combination of two medicines called nivolumab and bempegaldesleukin (37 people), one group received nivolumab alone (37 people), and one group received standard of care treatment (40 people). The trial was measuring two main things: whether any cancer remained in tissue removed during surgery (called a "pathologic complete response"), and how long people went without their disease getting worse or dying (called "event-free survival"). The study was ended earlier than originally planned, which affected the amount of data available. The reported data shows that when looking at the absence of cancer in surgical tissue samples, 10.8% of participants in the nivolumab-plus-bempegaldesleukin group had no cancer detected, compared with 2.5% in the standard-of-care group. The same figures of 10.8% versus 2.5% were also reported when comparing nivolumab alone to standard of care. For how long people remained free of disease-related events, the reported figure was 22.11 months for the combination group and 15.18 months for the standard-of-care group. For nivolumab alone compared to standard of care, the event-free survival figure for the nivolumab group was not reported (listed as not available in the data), while the standard-of-care group again showed 15.18 months. The reported data shows that overall survival figures — meaning the time from joining the study until death — were not calculated for either the combination group or the nivolumab-alone group, because too few deaths had occurred by the time the study closed early. Instead, a separate measure called "time to death" was reported: 6.77 months for the combination group, 9.43 months for the nivolumab-alone group, and 8.49 months for the standard-of-care group. For overall survival in the standard-of-care group only, the reported figure was 23.23 months. These numbers reflect only the participants in this trial and the specific conditions under which it was run. 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 ↗
NCT04525131 · results posted 18 June 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants, all of whom completed the study. The trial was testing a treatment called CPX-POM and was primarily focused on tracking unwanted health events (called adverse events) that participants experienced, including how serious those events were and whether any participant had to miss too many doses because of them. The reported data shows that out of the 12 participants, 9 experienced at least one adverse event (an unwanted health occurrence during the trial). One participant experienced a serious adverse event — meaning an event considered more severe in nature. Two participants were recorded as having a dose-limiting toxicity, which means they either experienced a significant unwanted reaction or were unable to receive at least 4 out of 5 planned doses of the treatment due to such reactions. For the secondary outcome, the reported data shows that 4 participants experienced adverse events that were considered related to the treatment itself. It is worth noting that this was a small study with only 12 participants, and the trial was designed to measure these kinds of health events rather than to test whether the treatment worked against a disease. No comparison group was included in the 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT03621982 · results posted 13 June 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03621982) enrolled 83 people in total across 14 different dose groups. Participants received either ADCT-301 (also called camidanlumab tesirine) on its own at one of eight different dose levels, or ADCT-301 combined with another drug called pembrolizumab at one of six different dose levels. The trial was primarily measuring what happened to participants in terms of medical events, serious medical events, and any changes to their dosing during the study period — in other words, it was tracking what occurred while people were on the treatment rather than measuring a specific disease response. The reported data shows that across the monotherapy (ADCT-301 alone) groups, all participants who started the trial experienced at least one treatment-emergent adverse event — that is, a medical event that occurred or got worse during the treatment period. In the combination therapy groups, results were reported for four of the six groups, with numbers ranging from 1 out of 1 participant up to 10 out of 10. Serious adverse events (those considered more significant, such as events requiring hospitalisation) were also recorded across most groups, ranging from 1 to 8 participants per group. The reported data shows that none of the serious adverse events in any group were graded at the most severe levels (grades 3–5 on the severity scale used). Dose reductions were reported as zero across all groups, and dose interruptions (temporary pauses in treatment) were reported for only one participant, in the 30 µg/kg combination therapy group. Data for the two highest-dose combination therapy groups (80 µg/kg and 100 µg/kg) were not reported for several of these 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.

Read the full trial page · View reported results on ClinicalTrials.gov ↗
NCT02451423 · results posted 31 May 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT02451423) enrolled 23 people with bladder cancer across three groups: 6 received a single dose of atezolizumab (also known as MPDL3280A) before surgery, 6 received two doses, and 11 received three doses. All 23 participants completed the study. The trial was primarily measuring how certain immune cells — different types of T cells, which are part of the body's immune system — changed in bladder tumour tissue between a biopsy taken before treatment and tissue removed during surgery. It also tracked whether treatment caused any delays to scheduled surgery beyond 12 weeks. The reported data shows changes in immune cell levels were measured using a mathematical scale (where a positive number means more cells were detected after treatment compared to before, and a negative number means fewer). For the broadest category of T cells (CD3+), the one-dose group showed a reported change of −0.04, the two-dose group −0.04, and the three-dose group 1.52. For a specific "killer" T-cell type (CD8+), the reported figures were 0.94 (one dose), 0.67 (two doses), and 2.02 (three doses). For helper T cells (CD4+ FoxP3−), values were approximately 0.83, 0.83, and 0.66 across the three groups. For regulatory T cells (CD4+ FoxP3+), figures were 1.56, 2.90, and 0.24. Data for proliferating T cells (CD3+ Ki67+) was not reported in the submitted results. Regarding surgery timing, the reported data shows that 0% of participants in every group experienced a treatment-related delay to their surgery. 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 ↗
NCT04046094 · results posted 4 March 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04046094) enrolled 12 participants, all of whom received intravenous (IV) ascorbic acid (a form of vitamin C given directly into the bloodstream). All 12 participants completed the trial with none dropping out. The trial was looking at people with bladder cancer, and the main thing it set out to measure was the stage of the cancer — essentially how far it had spread — after treatment, based on tissue examined following surgery. Two further outcomes were also planned: participants' quality of life (using a bladder-cancer-specific questionnaire) and how long participants remained free of the disease after surgery. The reported data shows that, of the 12 participants, the post-treatment cancer staging results were recorded as follows: 3 participants were at one stage category, 2 at another, 1 at another, 4 at another, and 2 at the remaining category. The exact labels for each stage category were not included in the structured data submitted, so it is not possible to say precisely which number corresponds to which named stage. For the two secondary outcomes — the quality-of-life questionnaire scores and the disease-free survival rate — no numerical results were reported in the data submitted to ClinicalTrials.gov. Because the quality-of-life and disease-free survival data were not reported, those parts of the trial's findings are not available from this source. The reported data shows only the staging breakdown described above for the primary outcome. 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 ↗
NCT04806334 · results posted 26 December 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 11 participants, all of whom were in a single group that underwent a combination of a specialised MRI scan of the pelvis and bladder (called 4D MRI) along with genetic analysis of their bladder tumour. The trial was exploring what is known as "radiogenomics" — linking information from medical imaging with information from the genetic makeup of a tumour. Ten of the 11 participants completed the study, and one did not complete it (the reason was not reported in the data). The reported data shows that the trial had one primary outcome measure: how many participants went through both the MRI imaging and the tumour genetic sequencing successfully, producing useable results that could potentially point to a pattern linked to muscle-invasive bladder cancer (a form of bladder cancer that has grown into the muscle wall). According to the results reported on ClinicalTrials.gov, 10 out of 11 participants reached this point with useable data. No other outcome measures were included in the submitted results data. It is worth noting that this appears to have been a small, early-stage study focused on whether this combined imaging-and-genetic approach could be carried out and produce workable information, rather than a larger trial testing a treatment. No additional outcome figures — such as measures of how well any treatment performed — 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 ↗
NCT02807636 · results posted 13 December 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,213 people across three groups: 400 received a placebo combined with chemotherapy drugs (gemcitabine and carboplatin or cisplatin), 451 received the immunotherapy drug atezolizumab combined with the same chemotherapy, and 362 received atezolizumab on its own. The trial was measuring two main things: how long participants lived without their disease getting worse (called progression-free survival), and how long participants lived overall (called overall survival). The reported data shows that none of the participants were recorded as having "completed" the study in the formal sense, meaning all participants either experienced an event (such as disease progression or death) or left the study before its end. The reported data shows the following numbers for the main outcomes. For progression-free survival — the time from joining the trial until the disease got worse or a person died — the placebo-plus-chemotherapy group recorded a median (the midpoint figure, where half lasted longer and half shorter) of about 6.3 months, compared with about 8.2 months in the atezolizumab-plus-chemotherapy group. For overall survival, the placebo-plus-chemotherapy group recorded a median of about 13.4 months, compared with about 16.1 months in the atezolizumab-plus-chemotherapy group and about 15.2 months in the atezolizumab-alone group. The reported data also covers some secondary (additional) outcomes. The proportion of participants whose tumours showed a measurable reduction — known as the objective response rate — was reported as about 44.8% in the placebo-plus-chemotherapy group, 48.1% in the atezolizumab-plus-chemotherapy group, and 24.2% in the atezolizumab-alone group. Among those who did show a tumour response, the length of time that response lasted was reported as a median of about 8.2 months in the placebo-plus-chemotherapy group and about 9.1 months in the atezolizumab-plus-chemotherapy group; duration of response for the atezolizumab-alone group was not 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04045613 · results posted 13 October 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04045613) enrolled a total of 95 participants across seven different treatment groups, organised into five "substudies." Each substudy tested different doses and combinations of two medicines — derazantinib and atezolizumab — in people with certain types of cancer. The trial was measuring things like how many participants' tumours shrank or disappeared, how long any such response lasted, and — for one substudy — what dose of the combination was considered suitable to take forward into further research. The reported data shows that for the main question of how many participants had their tumours shrink or disappear (called the "objective response rate"), the figures varied across groups. In Substudy 1 (derazantinib alone, once daily), 9.4% of participants met this measure. In Substudy 4, Cohort 4a (derazantinib alone, once daily), the figure was 14.3%, while Cohort 4b (derazantinib plus atezolizumab) reported 0.0%. In Substudy 5 (derazantinib twice daily), 5.9% met the measure. Substudies 3 and the lower dose in Substudy 2 reported 0.0%. For a broader measure — participants whose disease either shrank or stayed stable (called "disease control rate") — reported figures ranged from 18.2% to 52.9% depending on the group. For how long a response lasted, where data was reported, the figures were 6.9 months (Substudy 1), 7.4 months (Substudy 2, higher dose), and 3.3 months (Substudy 4, Cohort 4a); the remaining groups had no data reported for this measure. Regarding the dose-finding part of Substudy 2, the reported data shows that zero participants in either dose level experienced what the trial defined as a "dose-limiting side effect," and the dose recommended for future research was identified as 300 mg once daily in combination with atezolizumab. It is also worth noting that the reported data shows zero participants were recorded as having "completed" the study in any group — all participants were listed under "not completed," though the data does not explain the reasons for each individual case. 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 ↗
NCT03519256 · results posted 1 June 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03519256) enrolled 69 people across four treatment groups: 16 received nivolumab alone (Arm A), 26 received nivolumab plus a bladder treatment called BCG (Arm B), 17 received nivolumab plus an experimental drug called BMS-986205 (Arm C), and 10 received all three treatments combined (Arm D). The trial was primarily measuring the number of participants who experienced medical events — called adverse events — during the course of the study, including serious events, events that led to stopping treatment, immune-related reactions, deaths, and certain changes in liver test results. The reported data shows that adverse events of any kind were recorded in 15 of 16 participants in Arm A, all 26 in Arm B, 15 of 17 in Arm C, and all 10 in Arm D. Serious adverse events (meaning events serious enough to require hospitalisation, be life-threatening, or result in death) were recorded in 2 participants in Arm A, 4 in Arm B, 6 in Arm C, and 4 in Arm D. Adverse events that led to a participant stopping their treatment entirely were reported in 1 person in Arm A, 4 in Arm B, 8 in Arm C, and 7 in Arm D. Immune-related reactions — where the body's own immune system appeared to be involved — occurred in 1 person in Arm A, 10 in Arm B, 6 in Arm C, and 5 in Arm D. Deaths during the study period were reported for 0 participants in Arm A, 3 in Arm B, 2 in Arm C, and 0 in Arm D. Liver enzyme abnormalities (a sign picked up through blood tests) were also recorded in varying numbers across the groups, with Arm C having the highest counts 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.

View reported results on ClinicalTrials.gov ↗
NCT03785925 · results posted 28 March 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 188 people, all of whom received a combination of two drugs — bempegaldesleukin (also called NKTR-214) and nivolumab. Of those, 172 completed the study and 16 did not. The trial was primarily looking at what is called the "objective response rate" (ORR) — that is, the proportion of participants whose tumours showed a meaningful reduction in size, either disappearing completely or shrinking by at least 30% — specifically in people whose tumours had low levels of a protein called PD-L1 (a marker sometimes used to guide cancer treatment decisions). The reported data shows that, among participants with low PD-L1 levels, 22 people had a recorded response to the treatment combination, as assessed by an independent review panel. When looking at all 188 treated participants together, 37 people had a recorded response according to the same independent review, or 36 people when assessed by the treating doctors directly. In the low PD-L1 group, the doctors' assessment recorded 20 people with a response. The reported data also includes a measure called "duration of response" — meaning how long a response lasted in those who had one. For all treated participants, this was reported as 13.4 months by the independent review panel and 15.9 months by the treating doctors. For the low PD-L1 group specifically, the figures were 13.4 months (independent review) and 14.3 months (treating doctors). 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 ↗
NCT02281383 · results posted 29 December 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people, all of whom received a treatment called Bacillus Calmette-Guérin (BCG), a substance administered into the bladder. Of the 80 who started, 68 completed the trial and 12 did not finish. The trial was looking at how many participants showed no sign of bladder disease after treatment, as checked by two methods: a camera examination of the bladder (cystoscopy) and a urine test (cytology). It also tracked how many of those who initially showed no sign of disease remained disease-free over time. The reported data shows that, of the 68 participants who completed the study, 62 were recorded as showing no evidence of disease in their bladder based on both tests, while 18 were recorded as not achieving that outcome. (Note: because these two figures add up to 80 rather than 68, it is possible they reflect the full enrolled group; the submitted data does not clarify this point further.) For the secondary outcome, the reported data shows that 85% of participants who had initially shown no evidence of disease remained free from recurrence over the follow-up period, though the exact length of that follow-up period 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.

View reported results on ClinicalTrials.gov ↗
NCT02581982 · results posted 5 October 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 27 people who received a combination of two medicines — pembrolizumab and paclitaxel. Of those 27 participants, 11 completed the study and 16 did not complete it. The trial was primarily looking at how many participants had their cancer shrink or disappear (called the "overall response rate"), and also tracked how long people went without their cancer getting worse, as well as any unwanted health events (adverse events) that occurred. The reported data shows that, of the participants assessed for how their cancer responded, 3 had a complete response (meaning all detectable signs of cancer disappeared), 6 had a partial response (meaning the cancer shrank by at least 30%), 9 had stable disease (meaning the cancer neither shrank enough to count as a response nor grew enough to count as progression), and 7 had progressive disease (meaning the cancer grew by at least 20%). For the secondary outcomes, the reported data shows that 44% of participants went without their cancer getting worse at 6 months. Regarding unwanted health events, 34 were recorded in one category and 61 in another, though the data as reported does not break these down further by type or severity in this summary. 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 ↗
NCT02500121 · results posted 30 September 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT02500121) enrolled 108 people in total — 53 in the control group (Arm A, which received a placebo) and 55 in the experimental group (Arm B, which received pembrolizumab). The trial was looking at how long participants went without their cancer growing or spreading (called "progression-free survival"), as well as a number of other measures including how long people lived overall, how many showed tumour shrinkage, and what side effects were recorded. Notably, 27 people from the control group later crossed over to receive pembrolizumab after their disease progressed. The reported data shows that, for the main measure — the time from joining the trial until the cancer progressed or the person died — the median (the midpoint value across all participants) was 3.0 months in the control group and 5.4 months in the experimental group. When looking at the probability of being alive and progression-free at 6 months, the reported figures were approximately 0.26 (about 26 in 100 people) in the control group and 0.41 (about 41 in 100 people) in the experimental group. For overall survival, the reported median time was 18.7 months in the control group and 22.0 months in the experimental group. Regarding tumour response (meaning the percentage of participants whose tumours shrank to a meaningful degree), the reported data shows 10% in the control group and 23% in the experimental group; among the 27 people who crossed over from the control group to pembrolizumab, the reported response rate was 22%. The reported data also recorded side effects: 38% of participants in the control group and 59% in the experimental group experienced severe side effects (graded 3 or 4 on a standard medical scale, meaning significant or serious in nature). These figures describe what was observed and recorded in this specific trial population only. 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 ↗
NCT03558503 · results posted 25 July 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 63 people, all of whom received a treatment called UGN-102 (a gel-based bladder medication). Three participants did not complete the trial, leaving 60 who finished. The trial was designed to measure whether UGN-102 could eliminate detectable low-grade, early-stage bladder tumours, and then whether that result lasted over time. There was no comparison group — everyone in the trial received the same treatment. The reported data shows that the main thing being measured — called the "complete response rate" — was 65.1%. This means that, out of the participants assessed, 65.1% showed no detectable sign of disease based on a camera inspection of the bladder, tissue sampling where needed, and a urine test. For those who did achieve that result, the reported data shows it was maintained in 95.1% of them at the first follow-up check, dropping to 73.2% at a later check, and 61.0% at the furthest follow-up point. The specific time intervals for these follow-up checks were not clearly broken out in the data provided. The trial also tracked unwanted events that occurred during treatment. The reported data shows that 57 out of 63 participants experienced at least one treatment-emergent adverse event (meaning an unwanted health event that happened after treatment started). Of those, 40 participants had events considered related to the study drug or procedure. The reported numbers also indicate that 5 participants had serious adverse events, and 1 participant stopped treatment due to an adverse event. Separate monitoring of blood test results, vital signs, and physical examinations was also reported; no participants had clinically significant abnormal physical examination findings, while smaller numbers had notable changes in blood tests (8 participants for chemistry/haematology combined) or vital signs (8 participants). These figures describe what was observed and recorded — they do not indicate whether any of these events were expected or unexpected. 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 ↗
NCT02632409 · results posted 1 December 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02632409) enrolled 709 people in total — 356 were randomly assigned to receive a placebo and 353 to receive nivolumab (a type of immunotherapy). The trial was measuring how long people went without their cancer coming back or dying — a timeframe researchers call "disease-free survival." This was measured across all participants, and also looked at separately in a smaller group whose tumours showed a particular protein marker called PD-L1 at a level of 1% or higher. The reported data shows that, across all participants, the median time before cancer recurrence or death was reported as 10.84 months in the placebo group and 20.76 months in the nivolumab group. (Median means the midpoint — half the people in each group reached that point sooner, and half later.) For the subgroup with PD-L1 expression of 1% or higher, the placebo group had a reported median of 8.41 months, while the nivolumab group's median was listed as "NA" (not available or not yet reached at the time of reporting). For a related measure — how long before the cancer spread beyond the urinary tract or death occurred — the reported figures were 13.70 months for the placebo group and 22.93 months for the nivolumab group overall, and 10.84 months for the placebo group in the PD-L1 subgroup (with the nivolumab figure again not available). Data on overall survival — how long people lived in total — was listed as a secondary outcome but no numbers were 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 ↗
NCT00318643 · results posted 29 October 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 27 people in total across five groups (called cohorts). Each group received a combination of two substances — mitomycin C (MMC, a chemotherapy drug placed directly into the bladder) and increasing amounts of a product called Chemophase, ranging from 20,000 units in the lowest-dose group up to 800,000 units in the highest. The trial was primarily measuring whether there was a safe upper dose limit for Chemophase when given alongside MMC, and how many participants experienced serious unwanted reactions (called dose-limiting toxicities, or DLTs — reactions severe enough to cap how high the dose could go). The reported data shows that across all five groups, only one participant (in the 200,000-unit group) experienced a DLT. No DLTs were recorded in the other four groups, including the highest-dose group of 800,000 units. Based on these findings, the trial reported a maximum tolerated dose — the highest dose at which the number of serious reactions stayed within a pre-set acceptable limit — of 800,000 units, and this was also listed as the dose recommended for future studies. For a secondary measure looking at whether the MMC drug was absorbed into the bloodstream at detectable levels, the reported data shows that across all groups only one participant (in the highest-dose group) had a measurable blood concentration of MMC. Regarding unwanted events more broadly, the reported data shows that across all groups between 1 and 10 participants per group experienced at least one treatment-emergent adverse event (an undesirable occurrence after receiving the study drug). Serious adverse events were reported in 1 participant each in the lowest two groups, 2 participants in the 200,000-unit group, none in the 400,000-unit group, and 2 in the highest-dose group. Finally, for the measure tracking how many participants remained tumour-free at the end of the study, the numbers reported were: 2 of 3 in the lowest-dose group, 0 of 3 in the second group, 2 of 6 in the third, 1 of 3 in the fourth, and 6 of 12 in the highest-dose 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.

View reported results on ClinicalTrials.gov ↗
NCT03474107 · results posted 24 August 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03474107) enrolled 608 people in total — 301 assigned to receive enfortumab vedotin (a targeted cancer medicine given at a dose of 1.25 mg/kg) and 307 assigned to receive standard chemotherapy. The trial was designed to compare these two treatments in people with a type of urinary tract cancer (urothelial carcinoma). The main thing the trial set out to measure was how long participants lived overall (called "overall survival"), and a number of secondary measures were also tracked, including how long before the cancer grew or spread, how many participants' tumours shrank, and how participants rated their own quality of life. The reported data shows that the median overall survival — meaning the point in time by which half the participants in each group had died — was approximately 12.88 months in the enfortumab vedotin group and 8.97 months in the chemotherapy group. For the secondary measure of how long before the cancer progressed or participants died (progression-free survival), the reported median figures were 5.55 months for the enfortumab vedotin group and 3.71 months for the chemotherapy group. When looking at tumour response, the reported data shows that 40.6% of participants in the enfortumab vedotin group and 17.9% in the chemotherapy group had their tumour shrink to a meaningful degree. The proportion of participants whose disease either shrank or stayed stable (disease control rate) was reported as 71.9% versus 53.4% respectively. Among those whose tumours did respond, the median duration of that response was reported as 7.39 months for enfortumab vedotin and 8.11 months for chemotherapy. The reported data also shows that participants were asked to rate their general quality of life using a standard questionnaire (scored 0–100, where higher means better). From the start of the trial to week 12, the average score changed by −2.30 points in the enfortumab vedotin group and −5.72 points in the chemotherapy group, meaning both groups reported a small decline on average. 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 ↗
NCT02880176 · results posted 9 March 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 34 people in total — 23 in a group that received financial incentives to encourage walking, and 11 in a control group that received education only. The trial was looking at whether offering money as a reward would help bladder cancer patients who had just had their bladder removed walk more during the 30 days after their operation. Participants wore step-counting devices, and the trial tracked how often they hit a daily step target, how many steps they took on average each day, and also gathered information about their health and ability to carry out everyday tasks in the weeks after surgery. The reported data shows that, when it came to the main thing being measured — the number of days each person reached their daily step goal — the financial incentive group hit their target on a median (meaning the middle value of the group) of 4.5 days, while the control group hit their target on a median of 9 days. For the secondary measure of average daily steps over the 30-day period, the financial incentive group recorded a median of 979 steps per day, compared to 1,191 steps per day in the control group. On the everyday task questionnaire (scored from 0, meaning no difficulty, to 4, meaning complete difficulty with daily tasks), the financial incentive group scored a median of 1.25 and the control group scored 1.38. No numbers were reported for the measure tracking complications, unplanned hospital readmissions, or emergency department visits, so those results are not available 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 ↗
NCT03125226 · results posted 25 February 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants, all of whom completed the study. The trial was looking at whether a hydrogel called TraceIT, injected into the bladder area, could help doctors track the location of the tumour bed (the area where a tumour was or is) during a course of radiation therapy. Specifically, researchers measured how much the marker moved between treatment sessions, how much the tumour bed changed in size and shape over the weeks of treatment, and how accurately radiation could be delivered to the target area. The reported data shows that, on average, the hydrogel marker moved about 0.62 cm between treatment sessions, and the size/shape of the tumour bed changed by about 0.21 cm on average over the course of treatment. For the secondary measurements, the reported data shows that when radiation planning was aligned to the hydrogel marker's location, the target area (called the Planning Tumour Volume, or PTV — the zone doctors aim radiation at) received 99% of the intended radiation dose. When alignment was based on the hydrogel compared against whole bladder position or bone landmarks, the reported figure was 95% of the intended dose reaching the PTV. The reported data also shows that a setup margin (a buffer zone around the tumour to account for movement) of 10 mm may be sufficient for consistent coverage of the tumour area, compared to the current common practice of at least 20 mm. Finally, the reported data shows that zero participants experienced adverse events (unwanted side effects) that were attributed to the hydrogel itself, though this figure should be interpreted with care given the small number of participants. It is worth noting that with only 12 participants, this was a small study, and the figures above reflect only this particular 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.

View reported results on ClinicalTrials.gov ↗
NCT02603432 · results posted 17 December 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02603432) enrolled 350 people in each group — one group received avelumab (an immunotherapy medicine) plus best supportive care, and the other received best supportive care alone. The trial was primarily measuring overall survival, meaning how long participants lived from the time they joined the study. It also tracked several secondary measures, including how long it took before cancer showed signs of growing or spreading (progression-free survival), how many participants had their tumours shrink or disappear (objective response), and how quickly any such response appeared. The reported data shows that, on average, participants in the avelumab plus best supportive care group lived for a reported median of 21.4 months, compared with 14.3 months in the best supportive care only group. A "median" here means the midpoint — half of participants in each group lived longer than that figure, and half did not reach it. For progression-free survival (time before the cancer grew or the person died), the independent review reported a median of 3.7 months in the avelumab group versus 2.0 months in the supportive care group; the treating doctors' own assessments reported 5.5 months versus 2.1 months. Regarding tumour shrinkage, the reported data shows that approximately 9.7% of participants in the avelumab group had a measurable reduction in tumour size as assessed by independent review, compared with 1.4% in the supportive care group. The time to first recorded tumour response was reported as 2.0 months in both groups. It is worth noting that very few participants were recorded as having "completed" the study in the conventional sense — 16 in the avelumab group and 1 in the supportive care group — with the remainder not completing the study for various reasons, which is common in trials involving serious illness. 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 ↗
NCT02780687 · results posted 12 October 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02780687) enrolled 42 people across two groups: 34 participants in Cohort A and 8 participants in Cohort B. The trial was studying afatinib, a cancer medicine, and was primarily looking at how many people in Cohort A were still alive and had no signs of their cancer growing at the six-month mark. Secondary measurements included how many people's tumours shrank or disappeared, how long it took before the cancer started growing again, how long people lived overall, and how many people had their cancer kept under control by the treatment. The reported data shows that out of the 34 people in Cohort A, 4 were alive and free from cancer progression at the six-month tumour assessment — this was the main result the trial was designed to measure. Among the secondary results for Cohort A: 2 participants had their tumours confirmed as having shrunk or disappeared; 17 participants were reported as having their disease controlled (meaning their cancer either shrank, disappeared, or did not grow significantly); and for those with disease control, that period of control lasted an average of around 22.7 weeks. The reported data also shows that, on average, it took approximately 9.8 weeks before the cancer started progressing again in Cohort A, and participants lived for an average of around 30.1 weeks from the start of treatment. No outcome results for Cohort B were reported in the data provided. It is worth noting that the reported data shows zero participants were recorded as having "completed" the study in either group, though this likely reflects how completion was defined for this particular trial rather than meaning all participants dropped out — however, the data as submitted does not explain this further. 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 ↗
NCT03498196 · results posted 24 August 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03498196) enrolled only one participant, who received a treatment called Avelumab. The trial was designed to look at several things: changes in certain immune cells (called T cells) in tumour tissue before and after surgery, whether the cancer showed signs of responding to treatment at the time of surgery, how long participants remained free of disease over two years, and how many participants experienced serious side effects (graded 3 or 4 on a standard medical scale, meaning significant or severe). The reported data shows that for the main (primary) outcome — measuring changes in immune cells in tumour tissue — no results were submitted to ClinicalTrials.gov, so those figures are not available. For the secondary outcomes, the reported data shows that zero out of one participant had a pathological response (meaning no signs of a treatment response were detected in the tissue removed during surgery). The single participant's disease-free survival was reported as approximately 5.48 months after surgery. The reported data also shows that one participant (the only participant in the trial) experienced a high-grade (serious) adverse event during the study period. It is worth noting that because only one person took part in this trial, the reported numbers reflect the experience of a single individual and cannot be used to draw broader 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT00462488 · results posted 12 May 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT00462488) enrolled 46 people with a type of early-stage bladder cancer called carcinoma in situ (cancer that has not grown into the muscle wall of the bladder). Participants were split into two equal groups of 23 — one group followed Treatment Schedule A and the other followed Treatment Schedule B. The trial was testing a treatment called Vicinium, and the main thing being measured was how many participants showed a "complete response" (meaning no detectable cancer) after an initial treatment phase of roughly 12–13 weeks. The reported data shows that in the Schedule A group, approximately 40.9% of participants had a complete response at the 12-week check point. In the Schedule B group, approximately 39.1% of participants had a complete response at the 13-week check point. It is also worth noting that a number of participants did not finish the full study — 20 out of 23 in Schedule A and 17 out of 23 in Schedule B did not complete all stages, though the reasons for this were not detailed in the data provided here. No secondary outcome measure results were included in the data submitted. The reported data does not include any further breakdown of results beyond this initial response rate, and no additional outcome figures were reported in the structured data available. These numbers describe only what was measured and recorded at a single point in time during the trial, for this particular group 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT02401542 · results posted 17 February 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02401542) looked at three groups of participants receiving either vofatamab combined with docetaxel (a type of chemotherapy), vofatamab alone, or a placebo combined with docetaxel. A total of 71 people started the trial — 41 in the vofatamab plus docetaxel group and 30 in the vofatamab alone group. The placebo plus docetaxel group had zero participants recorded as starting, which may reflect how the trial was structured across its phases. Note that the data was not reported in a way that allows a straightforward comparison between all three original groups for the primary outcome. The main thing the trial was measuring was **progression-free survival (PFS)** — that is, the length of time (in months) from when a participant entered the trial until their disease either got worse or they passed away, whichever came first. The reported data shows PFS figures across five subgroups defined by tumour type and trial phase: the "Mut/Fus Phase 1" group had a reported PFS of 6.82 months; the "Wild Type Phase 1" group, 2.83 months; the "Mut/Fus Phase 2" group, 4.40 months; the "Mut/Fus Phase 2 Monotherapy" group, 4.45 months; and the "Mut/Fus Phase 2b Monotherapy" group, 2.23 months. No other outcome measures were included 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.

View reported results on ClinicalTrials.gov ↗
NCT01157676 · results posted 13 January 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 350 people with bladder cancer — 174 assigned to open radical cystectomy (traditional open surgery to remove the bladder) and 176 assigned to robotic-assisted radical cystectomy (a keyhole-style surgical approach using a robotic system). After some participants were found to be ineligible or withdrew before surgery, 152 people completed the open surgery and 150 completed the robotic surgery. The trial was measuring several things: how many people were still alive and free of cancer progression two years after surgery, surgical details such as blood loss and whether cancer cells were found at the edges of removed tissue (called "positive margins"), how many lymph nodes were removed, post-surgical complications, and patients' quality of life. The reported data shows that for two-year progression-free survival (meaning the proportion of people still alive with no sign of their cancer worsening at the two-year mark), the figure was 71.6% in the open surgery group and 72.3% in the robotic surgery group. For estimated blood loss during surgery, the open surgery group had a reported average of 700 ml, compared with 300 ml in the robotic surgery group. Regarding positive surgical margins (cancer cells found at the cut edges of tissue), 7 participants in the open group and 9 in the robotic group were reported to have this finding. Post-surgical complications were recorded across several severity categories for both groups, with numbers spread across those categories in a broadly similar pattern between the two groups. Quality of life scores — measured on a scale of 0 to 168, where higher means better — were reported at around 120–128 across both groups at the time points measured, with the data not showing a large numerical difference between groups at any 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04039867 · results posted 2 January 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 17 adults with recurrent or advanced bladder cancer (specifically a type called transitional cell carcinoma). All 17 participants completed the study. The trial was testing a combination of two chemotherapy medicines — oxaliplatin and gemcitabine — and was looking at how well the treatment was tolerated by the body, how many participants' tumours responded to the treatment, and how long participants lived overall. The reported data shows that all 17 participants experienced at least one treatment-emergent adverse event (that is, an unwanted or unexpected health event that occurred during or after receiving the treatment). For tumour response, the reported data shows that 5 out of 17 participants met the criteria for a response to treatment — meaning their tumours either disappeared entirely or shrank by at least 30% as measured on scans. For overall survival, the reported data shows a figure of 314 days on average, though the data as submitted does not clarify whether this represents a median (the middle value in a range) or another type of average. It is worth noting that this was a small trial with only 17 participants, and the results described here are simply the numbers as submitted by the trial sponsor. 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 ↗
NCT02999672 · results posted 28 August 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people in total — 13 in Cohort 1 (who had a type of bladder cancer called urothelial bladder cancer, or UBC) and 7 in Cohort 2 (who had pancreatic cancer or cholangiocarcinoma, a cancer of the bile ducts). The trial was testing a drug called trastuzumab emtansine and looking at how tumours responded to it, how long participants went without their disease getting worse, how long they survived overall, and what side effects they experienced. Notably, the data shows that none of the participants were recorded as having "completed" the study — all 20 were listed as "not completed." The reported data shows that for the main measure — whether tumours shrank significantly (defined as either disappearing entirely or reducing in size by at least 30%) — 0% of participants in Cohort 1 and 0% in Cohort 2 met that response threshold when confirmed. However, a separate figure reported under the same outcome measure shows 38.5% of Cohort 1 and 14.3% of Cohort 2 as the "best overall response" percentage of treated participants, though the data as submitted does not clearly reconcile these two sets of figures. For the secondary measures, the reported data shows that participants in Cohort 1 went an average of about 2.2 months without their disease progressing, compared to about 2.6 months in Cohort 2. Overall survival was reported as approximately 7 months for Cohort 1; for Cohort 2 this figure was listed as "not available." Regarding side effects, the reported data shows that 84.6% of Cohort 1 and 100% of Cohort 2 experienced some form of adverse event, and serious adverse events were reported in 23.1% of Cohort 1 and 57.1% of Cohort 2. No participants in either group met the criteria for a specific type of liver injury known as Hy's Law. Blood concentration levels of the drug were reported for both groups across several time points, though some early time-point figures 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.

View reported results on ClinicalTrials.gov ↗
NCT02426125 · results posted 8 March 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 530 people with cancer — 263 were assigned to receive ramucirumab combined with docetaxel (a chemotherapy medicine), and 267 received a placebo (an inactive substance) combined with docetaxel. The trial was primarily measuring how long participants went without their disease getting worse (called "progression-free survival"), and also tracked a number of secondary outcomes including how long participants lived overall, how many showed tumour shrinkage, and how participants rated their own quality of life. The reported data shows that, for the main outcome, participants in the ramucirumab plus docetaxel group went a median of 4.07 months before their disease progressed or they died, compared with 2.76 months in the placebo plus docetaxel group. (Median means half the participants in each group had results above this figure and half below.) For overall survival, the reported median was 9.40 months in the ramucirumab group and 7.85 months in the placebo group. Regarding tumour response, about 25.9% of participants in the ramucirumab group showed a measurable reduction in tumour size, compared with 13.9% in the placebo group. Disease control (meaning the tumour either shrank or stayed stable) was reported in 65.4% of the ramucirumab group and 55.1% of the placebo group. Among those who did respond, the reported duration of that response was a median of 5.32 months in the ramucirumab group and 4.17 months in the placebo group. The reported data also shows that the time before participants reported a meaningful drop in their quality of life (a fall of 10 or more points on a standard 100-point quality-of-life scale) was a median of 6.87 months in the ramucirumab group and 4.60 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT01732107 · results posted 22 August 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01732107) enrolled 13 participants, all of whom received a drug called dovitinib. The trial was studying dovitinib as a treatment for a type of bladder cancer called urothelial carcinoma. The main thing the trial set out to measure was how many participants showed a "complete response" at 6 months — meaning no sign of any remaining bladder tumour detected by a camera examination of the bladder and tissue sampling at that time point. The reported data shows that 8% of participants (roughly 1 out of 13) met the definition of a complete response at 6 months. Regarding side effects, the trial tracked participants who experienced significant adverse reactions (rated as severe or higher on a standard medical grading scale). The reported data shows varying numbers of participants — ranging from 1 to 6 — experienced different types of side effects, though the specific names of each side effect were not included in the structured data provided. Notably, none of the 13 participants were recorded as having "completed" the study, with all 13 listed under "not completed." For several other planned measurements — including 1-year relapse-free survival, rates of cancer progressing to a more advanced stage, and 3- and 6-month partial response rates — 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 ↗
NCT00089128 · results posted 12 July 2018

According to the results reported on ClinicalTrials.gov, this clinical trial enrolled 16 participants, all of whom received a combination of two medicines called gemcitabine and irinotecan. All 16 participants completed the study, with none recorded as not completing it. The trial was set up to measure how often the treatment led to a response (meaning a reduction in cancer), how long any response lasted, how often side effects occurred, and how long participants lived without their disease getting worse. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures. This includes the primary measure — the proportion of participants who had a response — as well as the three secondary measures: how long any response lasted, the frequency of side effects (as assessed using a standard grading tool called the NCI Common Toxicity Criteria), and how long participants went without their disease progressing. Because no figures were provided in the submitted data, it is not possible to describe what those measurements showed. 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 ↗
NCT02560584 · results posted 2 July 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02560584) enrolled 304 participants, all placed in a single group called the "Cysview Arm." All 304 participants completed the trial with none recorded as dropping out. The trial was looking at a procedure called blue light cystoscopy using a product called Cysview (a dye used to help doctors examine the bladder), and comparing it with standard white light cystoscopy. The main thing being measured was whether blue light cystoscopy with Cysview could spot bladder cancer that standard white light cystoscopy missed. The reported data shows that, among participants whose cancer was confirmed by tissue testing, 13 people had their cancer detected only by blue light cystoscopy with Cysview — meaning it was not picked up using standard white light alone. For one specific type of bladder cancer called carcinoma in situ (CIS, meaning very early-stage cancer cells confined to the bladder lining), the reported data shows that 9 participants had this detected only by blue light cystoscopy with Cysview and not by white light cystoscopy. The reported data also recorded unwanted or unexpected health events (called adverse events) that were considered possibly related to Cysview and/or the blue light procedure. According to the results reported on ClinicalTrials.gov, 6 participants experienced such events during the surveillance (follow-up clinic) examination, and 3 participants experienced them across both the surveillance and operating room examinations combined. No further detail about the nature of these events was included 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 ↗
NCT01180478 · results posted 25 April 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 484 people in the Narrow Band Imaging (NBI) group and 481 people in the White Light group — a total of 965 participants. The trial was looking at whether the type of camera light used during a procedure to remove bladder tumours made a difference to how often bladder cancer came back within one year. One group had their procedure done using a special blue-tinted light called Narrow Band Imaging, while the other group had it done under standard white light. The trial also tracked what complications occurred within 30 days of the procedure, and whether any tumour remained or came back at an early check-up around three months later. The reported data shows that at the one-year mark, 104 out of 303 participants who completed the study in the NBI group, and 109 out of 293 in the white light group, had a recorded recurrence (meaning cancer was found again). At the three-month follow-up check, 59 participants in the NBI group and 61 in the white light group showed persistence or recurrence of tumours. Regarding complications in the 30 days after the procedure, the reported data shows that 415 NBI participants and 429 white light participants had no complications recorded (Grade I or none), while smaller numbers in both groups experienced complications of varying severity across the grading scale — with no deaths (Grade V) reported in either group. For recurrence specifically related to additional treatments given after the procedure, 27 participants in each group were recorded. 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 ↗
NCT02302807 · results posted 11 April 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02302807) enrolled 931 people in total — 464 assigned to standard chemotherapy (using one of three drugs: vinflunine, paclitaxel, or docetaxel) and 467 assigned to a medicine called atezolizumab. The trial was measuring how long participants lived overall, how long before their disease got worse, how long any shrinkage of tumours lasted, and what unwanted medical events occurred. Notably, the data shows that zero participants were recorded as having "completed" the study, with all participants listed under "not completed" — this likely reflects how the trial tracked its endpoint rather than meaning everyone dropped out, but the specific reasons were not reported in the structured data. The reported data shows that, looking at overall survival (how long participants lived from the start of the trial), the median time was 8.0 months for the chemotherapy group and 8.6 months for the atezolizumab group across all participants. When looking at a subgroup with particular biological markers (called IC1/2/3), those figures were 8.2 months and 8.9 months respectively; for a higher-marker subgroup (IC2/3), they were 10.6 months and 11.1 months. For progression-free survival — the time before the disease was recorded as getting worse — the reported median was 4.0 months for chemotherapy and 2.1 months for atezolizumab across all participants. For participants whose tumours did show a response, the reported median duration of that response was 5.3 months in the chemotherapy group compared with 21.7 months in the atezolizumab group across all participants (with similar patterns seen in the subgroups). The reported data also shows that unwanted medical events (adverse events) were recorded in 98.2% of chemotherapy participants and 95.0% of atezolizumab participants across the full group. Approximately one in three atezolizumab participants (33.3%) developed antibodies against the drug itself during the study. Blood level measurements of atezolizumab at various points during treatment ranged from a reported median of 67.5 to 223 micrograms per millilitre, though the specific time points for each measurement were not detailed 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT00598806 · results posted 15 August 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 812 people in total — 402 received a drug called apaziquone and 410 received a placebo (a dummy treatment with no active ingredient). The trial was looking at whether apaziquone, given directly into the bladder after surgery, could reduce the chances of bladder tumours coming back or getting worse over a two-year period. By the end of the study, 329 people in the apaziquone group and 346 in the placebo group had completed the trial. The reported data shows that, for the main outcome — tumour recurrence (coming back) within two years — 112 out of 170 participants in the apaziquone group experienced a recurrence, compared with 138 out of 160 in the placebo group. For the time until a recurrence occurred, the reported average was 18.1 months in the apaziquone group and 16.7 months in the placebo group. Regarding how often recurrences happened per person across the study, the reported figures were 0.6 times on average in the apaziquone group and 0.9 times in the placebo group. The reported data also shows that, for tumour progression (the cancer moving to a higher stage or grade), 29 out of 253 participants in the apaziquone group experienced progression, compared with 37 out of 261 in the placebo group. The average time to progression was reported as 22.7 months for apaziquone and 21.9 months for placebo, and the disease-free interval (time before progression or death from any cause) was also reported as 22.7 months versus 21.9 months 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.

View reported results on ClinicalTrials.gov ↗
NCT03159143 · results posted 11 August 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 22 participants, all of whom completed the study. Every participant received the same combination treatment of two chemotherapy medicines — docetaxel and oxaliplatin. The trial was designed to measure how often tumours shrank by a meaningful amount, how long it took for the disease to get worse, how many participants had their disease controlled to any degree, and how long participants lived overall. The reported data shows that 11% of participants experienced a reduction in measurable tumour size of 30% or more — this is what the trial defined as a "response." For a secondary measure called Disease Control Rate — which counted anyone whose disease either shrank or stayed stable — the reported figure was 26.3% of participants. The reported data also shows that the middle point for time to progression (meaning the time before the disease got worse) was 3 months, and the middle point for overall survival (time from first treatment until death or the end of the data collection period) was 7 months. It is worth noting that this was a small study of 22 people, so these figures come from a limited group. The reported data describes what was measured and observed in this particular group of participants only. 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 ↗
NCT02387996 · results posted 24 May 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 270 participants, all of whom received nivolumab at a dose of 3 mg/kg. The trial was measuring how often the treatment caused tumours to shrink or disappear (called the "objective response rate"), how long participants lived without their cancer getting worse ("progression-free survival"), and how long participants lived overall ("overall survival"). The trial also looked at whether a protein called PD-L1 — found on some cancer cells — affected any of these results. None of the 270 participants were recorded as having completed the study in the usual sense, as all 270 were listed under "not completed," which likely reflects that follow-up was ongoing or participants had left the study for various reasons before a formal completion point. The reported data shows that, as assessed by an independent review panel, about 19.6% of all participants had their tumours shrink or disappear to a meaningful degree. When broken down by PD-L1 levels, the reported response rates ranged from approximately 15.8% to 28.4% depending on the subgroup. When the treating doctors made their own assessments, the reported response rate across all participants was 24.8%, with subgroup figures ranging from roughly 19.9% to 33.7%. The reported median time until cancer stopped getting worse (progression-free survival) was around 1.87 to 3.68 months depending on the group measured, and the reported median overall survival ranged from approximately 5.95 to 13.54 months across the different subgroups. The median time from first dose until a response was first recorded was reported as approximately 1.97 months. It is important to note that these figures are summaries of what was recorded and submitted to a public registry — they describe what was measured in this specific group of trial participants under the conditions of 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.

Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT02002689 · results posted 2 May 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT02002689) enrolled 10 participants, all of whom received the study drug sonidegib. The trial was measuring two main things: how many participants' cancer responded to the treatment (either shrinking or staying stable for a meaningful period), and how long participants went without their cancer getting worse (called progression-free survival). Notably, none of the 10 participants completed the trial — all 10 left before it concluded, for reasons not detailed in the reported data. The reported data shows that for the primary outcome — overall response rate and clinical benefit rate — zero participants (0%) showed a complete response, partial response, or any measurable tumour shrinkage. Eight participants were recorded as having stable disease, and two were recorded as having progressive disease (meaning their cancer grew or spread). This means the reported overall response rate and clinical benefit rate were both 0%, as stable disease in this context did not meet the threshold of lasting 16 weeks or longer to count toward clinical benefit. For the secondary outcomes, the reported data shows the estimated percentage of participants who remained progression-free (meaning their cancer had not worsened) was 88.9% at one time point, dropping to 33.3%, then 33.3%, and finally 0.0% at later time points. The reported median progression-free survival — that is, the midpoint time at which half the participants had experienced disease progression or death — was 1.8 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.

View reported results on ClinicalTrials.gov ↗
NCT00506155 · results posted 31 March 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people, all of whom completed the study. Every participant received a combination of chemotherapy (called M-VAC) together with a drug called Avastin (bevacizumab) before surgery for bladder cancer. The trial was primarily measuring how many participants showed a specific response — defined as having little or no remaining invasive cancer left in the tissue removed during surgery (described in the data as "downstaging"). It also tracked how many participants were still alive five years after starting treatment. The reported data shows two figures for the primary outcome: 38% and 53% of participants met the definition of this response (the data as submitted lists both figures without further explanation of what distinguishes them, so it is not possible to clarify the difference between those two numbers from the information provided). For the secondary outcome, the reported data shows that 63% of participants were recorded as alive at the five-year mark. It is worth noting that this trial had only one group — there was no separate comparison group receiving a different treatment — so all figures simply describe what was observed in the one group that 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT00666562 · results posted 28 March 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people in total, split across three groups: 11 received a placebo (a dummy treatment with no active ingredient), 10 received a lower dose (800 mg) of a green tea extract called Polyphenon E, and 10 received a higher dose (1,200 mg). All 11 placebo participants and all 10 in the higher-dose group completed the study, while 2 of the 10 in the lower-dose group did not finish. The trial was primarily measuring whether a compound found in green tea — called EGCG (epigallocatechin gallate) — could be detected in bladder tissue after people took the supplement before a scheduled bladder procedure. The reported data shows that EGCG levels measured in non-cancerous bladder tissue were 0.00 ng/mL (nanograms per millilitre, a unit of concentration) in the placebo group, 0.50 ng/mL in the lower-dose group, and 1.72 ng/mL in the higher-dose group. For cancerous bladder tissue, the reported levels were 0.00 ng/mL in both the placebo and lower-dose groups, and 2.54 ng/mL in the higher-dose group. Regarding changes in EGCG levels in the blood from the start to the end of the study, the reported data shows an average change of 0.28 ng/mL for the placebo group, 82.33 ng/mL for the lower-dose group, and 85.37 ng/mL for the higher-dose group. The reported data also includes measurements of several other markers in bladder tissue and blood (including a protein called IGF-1 and other compounds from the green tea extract), though the context needed to fully interpret those figures 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.

View reported results on ClinicalTrials.gov ↗
NCT02030574 · results posted 25 March 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT02030574) enrolled 2 participants, and both completed the study. The trial was looking at a combination of two chemotherapy medicines — gemcitabine and fractionated cisplatin — given before surgery to people with muscle-invasive bladder cancer who were not considered suitable for a standard higher dose of cisplatin. The main thing the trial set out to measure was how many participants showed a complete pathologic response, meaning no detectable cancer remaining based on established tumour assessment criteria. A secondary measurement tracked how many participants experienced side effects while on the treatment. The reported data shows that, for the primary outcome — the number of participants with a complete pathologic response — the figure recorded was 2 out of 2 participants. For the secondary outcome — the number of participants who experienced side effects during treatment — the figure reported was also 2 out of 2 participants. No further breakdown of the type or severity of side effects was included in the submitted results data. It is important to note that with only 2 participants involved, the numbers reported here are extremely small, and no broader conclusions can be drawn from them. 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 ↗
NCT00118040 · results posted 24 March 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people across three groups: 20 received a lower dose of genistein (300 mg), 20 received a higher dose (600 mg), and 20 received a placebo (a dummy pill with no active ingredient). Genistein is a naturally occurring compound found in soy. The trial was measuring biological markers — essentially chemical signals — in tumour tissue and urine samples taken from participants who had bladder cancer and were awaiting surgery. The main thing being measured was the activity of a protein called EGFR (a molecule involved in cell growth) in tumour tissue, and several secondary measurements looked at related markers in both tissue and urine. Not everyone finished the study: 19 completed in the 300 mg group, 18 in the 600 mg group, and 14 in the placebo group. The reported data shows that, for the primary outcome — the strength of EGFR activity signals in tumour tissue — the placebo group had the highest proportion of "strong" signals (93.33%), compared to 83.33% in the 600 mg genistein group and 52.63% in the 300 mg genistein group. When both genistein groups were combined, the reported figure was 67.57%. For the related primary measure in non-cancerous (benign) tissue nearby, the signal patterns were broadly similar across all groups, with "weak" signals being the most common category reported in every arm. For the secondary urine-based markers (BLCA-4 and Survivin), measured at the start of the study, at day 8, and just before surgery, the reported data shows relatively small numerical differences between groups across the time points — for example, BLCA-4 levels ranged roughly between 0.44 and 0.59 pg/ml across all groups and time points. Survivin levels in urine showed more variation between groups, ranging from around 16.0 to 84.4 pg/ml depending on the group and time point measured. 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 ↗
NCT00234494 · results posted 14 March 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 45 people, all of whom had metastatic transitional cell cancer — a type of cancer affecting the urinary tract. All participants received the same treatment combination of three medicines: cisplatin, gemcitabine, and bevacizumab. Forty-three participants completed the study, while two did not. The trial was measuring how long participants went without their cancer getting worse, how long they survived overall, and how their tumours responded to treatment. The reported data shows that, on average, participants went approximately 8.2 months without their cancer progressing (getting worse). The average overall survival time — meaning how long participants lived from the start of the trial — was reported as approximately 19.1 months. When it came to tumour response, the reported data shows that around 53% of participants had a complete response (meaning no detectable cancer was found), around 19% had a partial response (meaning the cancer shrank but did not disappear entirely), and when these two groups were combined, the overall response rate was reported as approximately 72% of participants. The duration of how long these responses lasted was not 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT00847015 · results posted 29 February 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 18 people with muscle-invasive bladder cancer (cancer that has grown into the muscle wall of the bladder). All participants received a combination of three medicines — gemcitabine, cisplatin, and sunitinib — before having surgery to remove the bladder. Fifteen of the 18 participants completed the study, while three did not. The trial was measuring how many people showed no remaining cancer in the surgically removed tissue after receiving this treatment combination. The reported data shows that when the removed bladder tissue was examined after surgery, approximately 6.67% of participants (roughly 1 in 15 who completed the study) had no detectable cancer at all — meaning no cancer cells and no spread to nearby lymph nodes. For a broader measure that included anyone whose cancer had not grown into the muscle layer, the reported data shows this was seen in 33% of participants. A third outcome measured how long it took for the disease to progress (that is, for cancer to return or spread elsewhere in the body); the reported figure for this was 10 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.

View reported results on ClinicalTrials.gov ↗
NCT01821105 · results posted 3 February 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 21 participants, all of whom completed the study. The trial was looking at whether a handheld probe — a small device used during surgery — could accurately locate tumour lesions in the body that had been identified beforehand using PET and CT scans (types of medical imaging). All 21 participants were in a single group that received both the preoperative PET and CT scans before the handheld probe was used. The reported data shows that when the handheld probe was used to find lesions during the procedure, 35 lesions were detected accurately, 8 lesions returned a result described separately in the data, and 2 lesions returned another separate result — however, the specific labels or categories for these three numbers were not clearly distinguished in the submitted data, so it is not possible to describe exactly what each figure represents beyond what was reported. For the secondary outcomes, the reported data shows that 48 lesions in total were detected across the tumour detection measure. Regarding adverse events (unwanted or harmful occurrences during the trial), the reported figure was 0 patients, meaning no adverse events or complications were recorded in the submitted results. It is worth noting that because this trial had only one group and no comparison group, the numbers describe what was observed in those 21 people only. The data as submitted does not allow for any broader conclusions to be drawn. 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 ↗
NCT00479089 · results posted 6 October 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people in total, split evenly into two groups of 25. One group received a chemotherapy drug called docetaxel (given weekly), and the other group received the same chemotherapy plus an additional drug called ZD1839 (also known as gefitinib). The trial was looking at how these two approaches compared in people receiving consolidation therapy — that is, treatment given after an initial course of cancer treatment to try to hold the disease at bay. The primary outcome the trial set out to measure was how many participants in each group were free from their cancer progressing at 9 months after starting consolidation therapy. The reported data shows that no numerical results were provided for this measure on ClinicalTrials.gov, so those figures are not available to report here. For the secondary outcomes, the reported data shows that the median overall survival — meaning the midpoint survival time across each group — was 18.0 months for the docetaxel-only group and 16.6 months for the docetaxel-plus-ZD1839 group. The median progression-free survival from the time of enrolment — meaning how long it was, at the midpoint, before the disease showed signs of worsening — was reported as 3.7 months for the docetaxel-only group and 4.4 months for the docetaxel-plus-ZD1839 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.

View reported results on ClinicalTrials.gov ↗
NCT02207608 · results posted 28 May 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT02207608) involved 30 people in total, split into two groups of 15. One group received a treatment called BCG alone (brand name Immucist®), and the other received Hyaluronic Acid. The trial was measuring levels of pain experienced by participants, using a simple 1-to-10 scale where 1 represents the least pain imaginable and 10 represents unbearable pain. The reported data shows two sets of pain scores for each group, which appear to represent measurements taken at different points during the trial. For the BCG alone group, the reported scores were 4.5 and 5.8 out of 10. For the Hyaluronic Acid group, the reported scores were 4.9 and 4.2 out of 10. One participant in the BCG alone group did not complete the trial, while all 15 participants in the Hyaluronic Acid group completed it. No explanation for the timing of the two measurements (for example, before and after treatment) was included in the submitted data, so that detail cannot be confirmed here. It is worth noting that the submitted results only included this one pain scale outcome — no other outcome measures were reported in the data provided to ClinicalTrials.gov. What these numbers mean in a broader medical sense, or how they compare to what might be expected, is not something that can be drawn from the figures alone. 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 ↗
NCT01777217 · results posted 16 January 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01777217) enrolled a total of 8 people — 4 in a group receiving a medication called solifenacin succinate, and 4 in a group receiving a placebo (an inactive treatment given for comparison). All 8 participants completed the study. The trial was measuring changes in urinary symptoms using a standard questionnaire called the American Urology Association Symptom Score (AUASS), which asks 7 questions about bladder and urinary symptoms. Each question is scored from 0 to 5, giving a total possible score between 0 and 35, where higher scores indicate more bothersome symptoms (scores of 1–7 are considered mild, 8–19 moderate, and 20–35 severe). The reported data shows the change in AUASS scores from the start of the study to the end. The group taking solifenacin succinate had a reported change score of 9.4, while the placebo group had a reported change score of 6.7. It is worth noting that the data provided does not include the starting scores or ending scores separately, so it is not possible to say in which direction (improvement or worsening) these changes went — that detail was not reported in the structured results submitted to ClinicalTrials.gov. It is also important to note that with only 4 people in each group, this was an extremely small trial, though no further interpretation of what that means for the results has been 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT00421889 · results posted 15 December 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 80 participants across nine different groups. The trial was testing a drug called belinostat (also known as PXD101), given in combination with two other cancer medicines — carboplatin and paclitaxel — in people with various solid tumours, including ovarian cancer and bladder cancer. The study was set up in several parts: an early dose-finding phase (Part A), a phase focused on ovarian cancer (Part B), a phase looking at other solid tumours with different infusion times (Part C), and a phase focused on bladder cancer (Part D). The main thing the trial was trying to find out was the highest dose of belinostat that could be given alongside the other two medicines without causing unacceptable side effects — this is called the "maximum tolerated dose." The reported data shows that, for the dose-finding part of the trial (Part A), the maximum tolerated dose of belinostat was recorded as 1,000 mg per square metre of body surface area per day. For the secondary outcomes — which were additional things the trial tracked — the number of participants who had the best recorded tumour response (meaning their tumour either disappeared completely or shrank significantly, based on a standard measurement system called RECIST) was: 1 person in the 600 mg dose escalation group with carboplatin only, 1 person in the highest dose escalation group (1,000 mg), 15 people in the ovarian cancer group (Part B), and 4 people in the bladder cancer group (Part D). All other groups recorded zero participants with that level of response. The reported data also shows the average time until the disease progressed (got worse) was approximately 195 days for the ovarian cancer group, 150 days for the other solid tumour group, and 136 days for the bladder cancer group. For two other secondary measures — "time to response" and "duration of response" — the reported data shows the values were listed as "not available" for the groups where they were measured, meaning those figures were not reported in the submitted results. The pharmacodynamic outcome (looking at biological changes in blood cells) also had no measurements 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 ↗
NCT01342172 · results posted 26 November 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01342172) enrolled 9 participants, all of whom completed the study — none dropped out. The trial was testing lenalidomide in combination with two other medicines, gemcitabine and cisplatin. The main goals were to find the highest dose of lenalidomide that could be given without causing serious side effects in more than one-third of participants (called the Maximum Tolerated Dose, or MTD), and — in a planned second phase — to measure how long participants went without their disease getting worse over one year. The trial appears to have only completed its first (dose-finding) phase. The reported data shows that the Maximum Tolerated Dose of lenalidomide was determined to be 10 mg per day. This means that at higher doses tested, more than one-third of participants experienced serious side effects as defined by the trial's criteria. For tumour responses, out of 9 participants: 1 had a complete response (all detectable tumour signs disappeared), 2 had a partial response (tumour shrank by at least 30%), 3 had stable disease (tumour neither shrank enough to count as a response nor grew enough to count as progression), 2 had progressive disease (tumour grew), and 1 participant's response category was also recorded separately. Regarding serious side effects (graded 3 or higher on a standard severity scale), the reported data shows 28 events of one type and 7 of another were recorded, though the data does not specify what those event types were. For participants who went on to maintenance treatment, 1 achieved a complete response and 2 achieved a partial response as their best overall result. The progression-free survival data for the one-year measure and the immune cell analysis were 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 ↗
NCT01663285 · results posted 18 September 2014

According to the results reported on ClinicalTrials.gov, this trial was testing a chemotherapy combination — gemcitabine and cisplatin — given *before* surgery in people diagnosed with a high-risk cancer of the upper urinary tract (called upper tract urothelial carcinoma). The trial intended to measure how long patients remained free of cancer returning over two years after treatment, how many patients showed little or no remaining cancer in the tissue removed during surgery, and how many experienced unwanted side effects from the chemotherapy. According to the results reported on ClinicalTrials.gov, only one person was enrolled in the study, and that one participant completed the trial. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the three outcome measures — the two-year recurrence-free survival time, the number of patients whose surgical specimens showed little or no remaining cancer, and the number of participants who experienced adverse events. All three measurement fields were left empty in the submitted data. Because only a single participant was enrolled — far fewer than would typically be needed to draw any meaningful conclusions — the absence of reported numbers is not surprising. In summary, due to the very small number of people who took part (just one), the reported data does not provide outcome figures for any of the measures this trial set out to assess. 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 ↗
NCT00808639 · results posted 15 May 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 39 people, all of whom received a chemotherapy regimen called "Dose Dense MVAC" (a combination of four chemotherapy medicines given on an accelerated schedule, with a supportive drug called pegfilgrastim to help protect the immune system). Thirty-eight of the 39 participants completed the study, with one person not completing it. The trial was primarily measuring how many patients showed a particular response in their pathology results — meaning that when tissue was examined after chemotherapy, the cancer appeared to have reduced to an early or limited stage. The reported data shows that 49% of participants achieved this pathological response (that is, their cancer had reduced to an early stage as seen under the microscope after chemotherapy). For the secondary measurements, the trial tracked two types of side effects. Febrile neutropenia — a potentially serious condition where a person develops a fever due to a drop in infection-fighting white blood cells — was reported in zero participants. Surgery-related side effects of a moderate or higher level that were considered possibly, probably, or definitely linked to treatment were reported in 4 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT00595088 · results posted 21 August 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 47 participants, all of whom received a treatment called BC-819/PEI (at a dose of 20 mg) delivered directly into the bladder. The trial was studying a type of bladder cancer, and the main thing researchers were measuring was whether participants showed a complete tumour response — meaning no new tumours were found — after an initial course of treatment. Seven participants were recorded as completing the trial, while 40 did not complete it. The reported data shows that 64.1% of participants met the definition of a complete tumour response at around 9 weeks into the trial (meaning no new tumours were detected at that check-up). For the secondary measures — things the trial was also tracking but were not the main focus — the reported data shows that the average time before tumours came back was 11.3 months. Additionally, when looking at a specific existing tumour that was deliberately left in place to track the treatment's direct effect (called a "marker tumour"), 33.3% of participants showed that tumour had completely disappeared. It is important to note that this trial had only one group of participants (there was no comparison group receiving a different or dummy treatment), and a large number of participants did not complete the trial. These numbers describe only what was observed and recorded in this particular study 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.

View reported results on ClinicalTrials.gov ↗
NCT01637935 · results posted 12 October 2012

According to the results reported on ClinicalTrials.gov, this study followed a large number of people with diabetes over a period from 1997 to 2012 — a total of 193,099 participants in all. Of these, 34,181 had taken the diabetes medicine pioglitazone (the "exposed" group), while 158,918 had not taken it (the "unexposed" group). The main thing the trial was measuring was how often a new diagnosis of bladder cancer occurred in each group, expressed as the number of cases per 100,000 person-years (a way of accounting for the fact that different people were followed for different lengths of time). The reported data shows that in the primary outcome, the pioglitazone-exposed group had a bladder cancer rate of 89.8 cases per 100,000 person-years, compared with 75.9 cases per 100,000 person-years in the unexposed group. The reported data also shows results broken down by how long people had been taking pioglitazone, how much of it they had taken in total, and how much time had passed since they started — with rates in the exposed group ranging from around 68 to 126 cases per 100,000 person-years across these different subgroups. Comparison figures for the unexposed group in these breakdowns were not reported. For the stage of bladder cancer at diagnosis, the reported figures were broadly similar between the two groups — for example, around 50% of cases in the exposed group and 49% in the unexposed group were recorded at one particular stage, with the remaining percentages spread across other stages in comparable proportions. 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 ↗

See the full Bladder Cancer page · What changed recently

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.