Ongoing Clinical Trials for Peritoneal Mesothelioma
There are currently 4 clinical trials investigating new treatments for peritoneal mesothelioma, a rare cancer affecting the lining of the abdomen. These studies are testing different approaches including immunotherapy medications, targeted therapies, and personalized cell treatments, often combined with surgery and chemotherapy. The trials are being conducted in France, Italy, and the Netherlands, offering opportunities for patients whose disease has progressed despite standard treatment.
Clinical trial locations
- France
- Italy
- Netherlands
Study of Tremelimumab for Patients with Unresectable Malignant Mesothelioma
This trial is testing a treatment called Tremelimumab in patients with mesothelioma that cannot be removed by surgery. The medication works by helping the immune system recognize and attack cancer cells.
Who can participate: Adults 18 years and older who have confirmed pleural or peritoneal mesothelioma that cannot be surgically removed. Patients must have received 1-2 previous treatments including pemetrexed combined with a platinum-based chemotherapy as their first-line treatment. Participants need to be generally active or have only mild symptoms (ECOG status 0-1) and must have recovered from side effects of previous treatments. The disease must be measurable by doctors, and patients need to have adequate bone marrow, liver, and kidney function. Negative tests for HIV and hepatitis A, B, and C are required.
Who cannot participate: Patients with another type of cancer that is likely to return, those with uncontrolled serious infections, pregnant or breastfeeding women, and people with conditions affecting their immune system are excluded. Patients taking medications that weaken the immune system, those who have had organ transplants, or who have a history of severe allergic reactions to similar treatments cannot join. People with unstable heart or lung conditions, or conditions affecting the brain or nervous system are also excluded.
What the trial involves: The study compares Tremelimumab given as an intravenous infusion against a placebo. The treatment is administered directly into the bloodstream and continues for up to 36 months. The main goal is to measure overall survival, which is the time from starting treatment until death from any cause. Researchers will also track how many patients survive at 18 months, how long the disease stays controlled, and the overall response rate. Regular check-ups and tests monitor both the cancer’s response and any side effects. Quality of life assessments are also conducted throughout the study.
Investigational drug: Tremelimumab is an immune checkpoint inhibitor that blocks a protein called CTLA-4, which helps regulate the immune system. By blocking this protein, the medication enhances the body’s immune response against cancer cells, helping the immune system better recognize and attack them.
Study on Talazoparib for Maintenance Treatment in Patients with Advanced Malignant Pleural or Peritoneal Mesothelioma After Initial Chemotherapy
This study examines whether Talazoparib can help prevent disease progression in patients who have already completed at least four cycles of platinum-based chemotherapy. The medication is taken as a capsule and serves as maintenance therapy after initial treatment.
Who can participate: Adults over 18 with confirmed epithelioid, sarcomatoid, or biphasic mesothelioma affecting either the pleura or peritoneum. Patients must have completed at least four cycles of platinum-based chemotherapy including pemetrexed without disease progression during treatment. There should be a gap of 6-8 weeks between the last chemotherapy cycle and starting the trial medication. Participants need adequate bone marrow function (specific blood cell counts), proper kidney function (calculated filtration rate of at least 30 ml/min), and liver function within acceptable limits. A life expectancy of at least 16 weeks and ECOG performance status of 2 or less is required. Tumor tissue samples must be available, and the disease must be measurable or evaluable on CT scans. Women of childbearing potential must use highly effective birth control during treatment and for 7 months after, while men must use condoms during treatment and for 4 months after completion.
Who cannot participate: Patients who have not completed at least four cycles of platinum-based chemotherapy or have not been diagnosed with advanced malignant pleural or peritoneal mesothelioma are excluded. Those who are not adults (under 18 years old) or who belong to vulnerable populations requiring special protection cannot participate.
What the trial involves: Treatment begins with Talzenna 1 mg capsules taken orally daily as maintenance therapy. The primary goal is to determine whether the disease remains stable without progression for at least 6 months after starting treatment. Some patients receive a placebo for comparison. The study includes regular monitoring visits with imaging tests such as CT scans to evaluate disease response. Follow-up assessments track overall survival and safety throughout the treatment period.
Investigational drug: Talazoparib is a PARP inhibitor that works by blocking an enzyme called PARP, which normally helps repair damaged DNA in cancer cells. By preventing this repair mechanism, the medication stops cancer cells from growing and dividing, ultimately leading to their death.
Study on the Safety and Effectiveness of Domvanalimab and Zimberelimab for Adults with Advanced Rare Cancers Resistant to Standard Treatment
This trial investigates a combination treatment approach for patients with five rare cancers, including peritoneal mesothelioma. The study tests whether combining two immunotherapy medications can provide an effective treatment option when standard therapies have failed.
Who can participate: Adults 18 years and older with one of five specific rare cancers: peritoneal mesotheliomas, gestational trophoblastic tumors, B3 thymomas and thymic carcinomas, anaplastic thyroid carcinomas, or gastroenteropancreatic neuroendocrine tumors and carcinoid tumors. The cancer must be advanced or metastatic (spread to other parts of the body) and must have progressed or become resistant after at least one previous standard treatment. Patients need a life expectancy of at least 16 weeks and an ECOG performance status of 0 or 1, meaning they can perform most daily activities. Adequate bone marrow function with specific blood cell levels, kidney function with creatinine clearance of at least 30 ml/min, and appropriate liver function are required. Patients must be willing to provide tumor tissue samples and agree to use highly effective contraception if they are of childbearing age. Affiliation with the French social security system and ability to comply with study procedures are necessary.
Who cannot participate: Patients without one of the five specified rare cancers, those whose cancer is not advanced or metastatic, and those whose cancer has not progressed or become resistant after at least one standard treatment line are excluded. The study is limited to adults only, excluding anyone under 18 years old. Vulnerable populations are also excluded.
What the trial involves: After initial assessment and confirmation of eligibility, treatment begins with both Domvanalimab and Zimberelimab administered through intravenous infusion directly into a vein. Regular study site visits are required for continued medication administration and health monitoring. After 24 weeks, a comprehensive evaluation assesses treatment response using imaging tests and other assessments. Long-term follow-up visits monitor ongoing health and any delayed treatment effects. Throughout the study, researchers track cancer progression rates and overall survival while carefully monitoring for side effects.
Investigational drugs: Domvanalimab and Zimberelimab are both antibody medications that work by helping the immune system fight cancer. They block specific proteins that normally help cancer cells hide from the immune system, allowing the body’s natural defenses to better detect and destroy cancer cells. Both medications are immunotherapy drugs that enhance the immune response against cancer.
Study on Nivolumab and MesoPher for Patients with Peritoneal Mesothelioma
This study combines immunotherapy medication, personalized cell therapy, surgery, and heated chemotherapy to treat peritoneal mesothelioma. The approach aims to use multiple treatment methods together to improve outcomes.
Who can participate: Adults at least 18 years old with epithelioid peritoneal mesothelioma confirmed by histology testing. Patients must be healthy enough to undergo cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC), a specialized surgical procedure with heated chemotherapy. Participants need to be able to return to the study center for follow-up visits and vaccinations. Men must agree to use reliable birth control during the study and for at least 12 months after the last treatment dose. Women of childbearing potential must have a negative pregnancy test before starting and agree to use reliable birth control during the study and for at least 12 months after completion. Written informed consent according to international guidelines is required.
Who cannot participate: Patients with any cancer type other than peritoneal mesothelioma are excluded. Those with another cancer in the past are excluded unless it was treated and has not returned for at least 5 years. Patients currently receiving any other cancer treatment, those with severe heart disease or uncontrolled high blood pressure, and people with active infections including HIV, hepatitis B, or hepatitis C cannot participate. Those who have had organ transplants or have autoimmune diseases (where the immune system attacks the body) are excluded. Pregnant or breastfeeding women, patients unable to follow study procedures or attend required visits, and those who participated in another clinical trial within the last 30 days are not eligible.
What the trial involves: Treatment begins with Nivolumab administered through intravenous infusion before surgery. This is followed by dendritic cell therapy called MesoPher, which uses personalized immune cells to help fight the disease. Up to five MesoPher administrations are given, depending on availability. The main treatment includes cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC), where heated chemotherapy is applied directly to the abdominal area during surgery. Regular follow-up visits include medical assessments and CT scans to monitor disease progression and treatment response.
Investigational drugs: Nivolumab is an immune checkpoint inhibitor given as an intravenous infusion that blocks a specific protein on immune cells, helping the body’s immune system better recognize and attack cancer cells. MesoPher is a dendritic cell therapy administered by injection that uses specialized immune cells to stimulate the body’s natural immune response against cancer cells. Both treatments fall under the category of immunotherapy, using the body’s own defense system to combat disease.
Summary
The four ongoing clinical trials for peritoneal mesothelioma reflect diverse therapeutic approaches to this rare and challenging cancer. The studies are distributed across three European countries, with France conducting two trials, and Italy and the Netherlands each hosting one.
A notable pattern is the focus on immunotherapy approaches, with three of the four trials testing immune checkpoint inhibitors either alone or in combination. Tremelimumab, Nivolumab, Domvanalimab, and Zimberelimab all work by enhancing the immune system’s ability to recognize and attack cancer cells, though they target different immune pathways. The Dutch trial takes a particularly comprehensive approach by combining immunotherapy with personalized cell therapy (MesoPher) alongside traditional surgery and heated chemotherapy.
The French trials represent two distinct strategies: one examining maintenance therapy with Talazoparib (a PARP inhibitor that prevents cancer cell DNA repair) after initial chemotherapy, and another testing a combination immunotherapy for multiple rare cancers including peritoneal mesothelioma. The Italian study focuses specifically on patients whose disease cannot be surgically removed, offering an option for those with unresectable tumors.
Most trials require patients to have received previous treatment, reflecting the reality that these studies target disease that has progressed despite standard care. This highlights the ongoing need for new treatment options in peritoneal mesothelioma, where conventional approaches often have limited success. The trials typically require good overall health status and adequate organ function, as intensive treatments demand that patients be strong enough to tolerate potential side effects.
