Trial 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
According to the results reported on ClinicalTrials.gov, this trial (NCT02357147) enrolled 108 people with a form of cancer called mesothelioma. Participants were split into two groups: 52 people received a drug called amatuximab combined with two standard chemotherapy medicines (pemetrexed and cisplatin), while 56 people received a dummy treatment (placebo) combined with the same two chemotherapy medicines. The trial was carried out in two phases — a combination treatment phase and a maintenance (ongoing) treatment phase — and the main thing being tracked was how many participants experienced unwanted health events, called adverse events and serious adverse events. The reported data shows that during the combination treatment phase, 50 out of 52 participants in the amatuximab group experienced some kind of adverse event, compared with 52 out of 54 treated participants in the placebo group. Serious adverse events during this same phase were reported in 15 participants in the amatuximab group and 11 in the placebo group. Moving into the maintenance phase (where participants received amatuximab or placebo on their own, without chemotherapy), 19 out of 25 treated participants in the amatuximab group and 21 out of 29 in the placebo group experienced adverse events, while serious adverse events were reported in 1 participant in the amatuximab group and 4 in the placebo group during this phase. No secondary outcome measure data was included in the submitted results. It is worth noting that the reported data does not include details on what specific adverse events occurred or how severe they were beyond the serious/non-serious distinction, so a full picture of what participants experienced is not available from this submission 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 full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Mesothelioma Trial, Terminated
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You must be at least 18 years old at the time you give your consent to join
- You must have a confirmed diagnosis of malignant pleural mesothelioma (MPM) that cannot be removed by surgery, and it must be the "epithelial" type (a specific cell type of this cancer)
- A stored tissue sample from your tumor must be available to be sent to the research team
- You must have at least one measurable tumor area visible on a CT or MRI scan
- Any other health conditions you have must be considered stable and well-managed for at least 30 days before the study starts, in your doctor's opinion
- You must be fairly active and able to care for yourself (rated 0 or 1 on a standard activity scale used by doctors)
- Your doctor must estimate that you are expected to live for at least 3 months
- Your blood counts, liver function, and kidney function must meet minimum healthy levels based on recent blood tests (confirm with trial site for specific numbers)
- Your kidneys must be functioning well enough based on a specific calculation using a blood test result
- If you are able to become pregnant, you must agree to use a highly effective form of birth control throughout the study and for at least 6 months after your last chemotherapy dose or 30 days after your last dose of the study drug — whichever is later; methods like condoms, the rhythm method, or withdrawal are not considered acceptable
- If you are a male participant, you must either have had a confirmed vasectomy or you and your partner must follow the birth control requirements above, continuing for 6 months after chemotherapy ends or 5 weeks after the last study drug dose — whichever is later; sperm donation is not allowed during the study or for 90 days after your last study drug dose
- Women who can become pregnant must not donate eggs for 6 months after their last dose of the study drug
- You must be willing and able to sign a consent form and follow all parts of the study plan
- If you were previously in this study and received the active study drug (amatuximab), you may be eligible to continue receiving it, at your doctor's discretion
Who may not be able to join:
- You have previously had systemic treatment (such as chemotherapy) or radiation therapy for your mesothelioma (limited local radiation for symptom control may be allowed — confirm with trial site)
- You have had another active, serious cancer requiring treatment within the past 5 years (non-invasive cancers that have been fully removed may be allowed)
- Your mesothelioma is a type other than epithelial (such as sarcomatous or mixed type), or it is located in the abdomen rather than the chest lining
- There is evidence that the cancer has spread to your brain or spinal cord
- You have an active hepatitis virus infection or an active HIV infection
- You have another serious illness, or an active bacterial or fungal infection, that your doctor believes could affect your safety or the study results
- You have significant heart disease, such as severe heart failure, poorly controlled chest pain, or a heart attack within the past 6 months
- You have a significant abnormal heart rhythm shown on a heart tracing (ECG), including a specific electrical abnormality (confirm with trial site); however, certain types of irregular heartbeat such as atrial fibrillation may still be allowed
- You have had a known serious allergic or sensitivity reaction to the study drug or similar antibody-based treatments in the past
- You are pregnant or breastfeeding; a pregnancy test will be required before starting the study
- Your doctor believes that any medical or other reason makes it unsafe or unsuitable for you to take part
- You are scheduled to have surgery to reduce the size of your tumor during the study
- You are currently in another clinical trial, or have taken an experimental drug or used an experimental device within the past 30 days (or longer, depending on how long that drug stays in your body)
- You were previously assigned to receive the inactive (placebo) version of the study drug in an earlier part of this trial
- You have not signed the most up-to-date version of the consent form for this study
- Your cancer has gotten worse or you have had side effects serious enough that continuing the study drug would not be appropriate
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.