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 evaluating various approaches including immunotherapy medications, PARP inhibitors, and personalized cell therapies, either alone or in combination with surgery and chemotherapy. Trials are taking place in France, Italy, and the Netherlands.
Clinical trial locations
- France
- Italy
- Netherlands
Study of Tremelimumab for Patients with Unresectable Malignant Mesothelioma
This trial is testing a medication called Tremelimumab, which works by helping the immune system recognize and fight cancer cells. The study compares Tremelimumab to a placebo to determine if it can improve survival in patients whose mesothelioma cannot be removed by surgery.
Who can participate: Adults aged 18 or older with confirmed pleural or peritoneal mesothelioma that cannot be surgically removed. Participants must have received 1-2 previous treatments, including chemotherapy with pemetrexed and a platinum-based drug. They should have good overall health, with a performance status of 0-1, meaning they can carry out normal activities or light work with some symptoms. Adequate bone marrow, liver, and kidney function is required, along with negative tests for HIV and hepatitis.
Who cannot participate: Patients with other recent cancers (unless unlikely to return), active infections, pregnancy or breastfeeding, immune system disorders, those taking medications that weaken the immune system, organ transplant recipients, history of severe allergic reactions to similar treatments, or unstable heart or lung conditions are excluded.
Treatment approach: Participants receive Tremelimumab or placebo through an intravenous infusion. The study will monitor survival and quality of life over up to 36 months, tracking how well the treatment works and any side effects that occur.
Study on Talazoparib for Maintenance Treatment in Patients with Advanced Malignant Pleural or Peritoneal Mesothelioma After Initial Chemotherapy
This trial examines whether Talazoparib, a PARP inhibitor taken as a capsule, can help keep the cancer from progressing after initial chemotherapy. The medication works by preventing cancer cells from repairing their damaged DNA, which stops them from growing and dividing.
Who can participate: Adults over 18 with confirmed epithelioid, sarcomatoid, or biphasic mesothelioma affecting either the pleura or peritoneum. Participants must have completed at least four cycles of platinum-based chemotherapy including pemetrexed, without disease progression during treatment. They should have adequate liver, kidney, and bone marrow function, a life expectancy of at least 16 weeks, and a performance status of 2 or less. Treatment must begin 6-8 weeks after the last chemotherapy cycle or surgery. A tumor sample less than 18 months old must be available.
Who cannot participate: Those who haven’t completed at least 4 cycles of platinum-based chemotherapy, individuals without confirmed advanced malignant mesothelioma, people under 18, and members of vulnerable populations are excluded.
Treatment approach: Talazoparib is taken daily as a maintenance treatment. The main goal is to assess whether the disease remains stable for at least 6 months after starting the medication. Some participants will receive a placebo for comparison. Regular monitoring includes imaging tests such as CT scans to evaluate the treatment’s effectiveness.
Study on the Safety and Effectiveness of Domvanalimab and Zimberelimab for Adults with Advanced Rare Cancers Resistant to Standard Treatment
This study tests a combination of two immunotherapy medications, Domvanalimab and Zimberelimab, for patients with several rare cancers including peritoneal mesothelioma. Both medications are antibodies that help the immune system better recognize and attack cancer cells by blocking proteins that allow cancer to hide from immune defenses.
Who can participate: Adults aged 18 or older with one of five rare cancers, including peritoneal mesothelioma, that is advanced or has spread and has progressed or become resistant after at least one standard treatment. Participants must have a life expectancy of at least 16 weeks, a performance status of 0 or 1, adequate bone marrow and organ function, and kidney function with creatinine clearance of at least 30 ml/min. They must provide a tumor tissue sample, agree to use effective contraception, and be affiliated with French social security.
Who cannot participate: Patients without one of the specified rare cancers, those whose cancer is not advanced or metastatic, those whose cancer has not progressed after standard treatment, people under 18, and members of vulnerable populations are excluded.
Treatment approach: Both medications are given through intravenous infusion. The study will monitor participants for up to 24 weeks to evaluate how well the combination works and track any side effects. The goal is to determine if these medications, working together, can provide a new treatment option for these challenging rare cancers.
Study on Nivolumab and MesoPher for Patients with Peritoneal Mesothelioma
This trial combines Nivolumab, an immune checkpoint inhibitor, with MesoPher, a personalized dendritic cell therapy. Nivolumab helps the immune system fight cancer by blocking a protein on immune cells, while MesoPher uses a patient’s own specialized immune cells to stimulate a stronger response against cancer. These treatments are used alongside cytoreductive surgery and heated chemotherapy applied directly to the abdomen.
Who can participate: Adults aged 18 or older with confirmed epithelioid peritoneal mesothelioma who are healthy enough to undergo cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Participants must be able to return for follow-up visits and vaccinations. Women of childbearing age must have a negative pregnancy test. Both men and women must agree to use reliable birth control during the study and for at least 12 months after the last treatment dose.
Who cannot participate: Patients with any cancer other than peritoneal mesothelioma, those with another cancer in the past 5 years (unless fully treated and not returned), those receiving other cancer treatments, patients with severe heart disease or uncontrolled high blood pressure, active infections including HIV or hepatitis, organ transplant recipients, those with autoimmune diseases, pregnant or breastfeeding women, those unable to follow study procedures, and participants in another trial within the last 30 days are excluded.
Treatment approach: Treatment begins with Nivolumab given before surgery, followed by dendritic cell therapy with up to five administrations. The main treatment includes cytoreductive surgery combined with heated chemotherapy applied directly to the abdominal area. Regular follow-up visits monitor health and disease progression through medical assessments and imaging tests like CT scans.
Summary
These four clinical trials represent diverse approaches to treating peritoneal mesothelioma, with studies distributed across three European countries. France hosts two trials, while Italy and the Netherlands each conduct one study. A notable pattern is the focus on immunotherapy approaches, with three of the four trials testing medications that work by enhancing the immune system’s ability to fight cancer.
The trials vary in their treatment strategies. Two studies focus on immunotherapy alone, one examines a PARP inhibitor for maintenance therapy after chemotherapy, and one combines immunotherapy with personalized cell therapy alongside surgery. Most trials are designed for patients who have already received standard treatments, reflecting the need for options when initial therapies are insufficient.
The medications under investigation include Tremelimumab, Talazoparib, Domvanalimab, Zimberelimab, Nivolumab, and MesoPher. These represent different therapeutic classes, from immune checkpoint inhibitors to DNA repair blockers to personalized cellular therapies, showing the range of scientific approaches being explored for this rare and challenging cancer.