Clinical Trials for Pleural Mesothelioma Malignant

There are currently 11 ongoing clinical trials investigating new treatments for pleural mesothelioma malignant, a rare cancer affecting the lining of the lungs. These studies are taking place across multiple European countries and are testing various immunotherapy drugs, chemotherapy combinations, vaccines, and innovative treatment approaches to improve patient outcomes.

Clinical trial locations

• Belgium
  • Study on Adding Atezolizumab and WT1/DC Vaccine to Standard Treatment for Patients with Epithelioid Malignant Pleural Mesothelioma
  • Study on Neoadjuvant Chemotherapy and Immunotherapy with Ipilimumab, Pemetrexed, and Drug Combination for Patients with Inoperable Pleural Mesothelioma
  • Study of WT1 LAMP mRNA DC Vaccine for Patients with Malignant Pleural Mesothelioma
• Denmark
  • Study of Nivolumab, Ipilimumab, and UV1 Vaccine for Patients with Malignant Pleural Mesothelioma After Initial Chemotherapy
  • Study of Volrustomig with Carboplatin and Pemetrexed for Patients with Unresectable Pleural Mesothelioma
• France
  • Study of Intrapleural Photodynamic Therapy with Aminolevulinic Acid Hydrochloride and Nivolumab for Patients with Malignant Pleural Mesothelioma
  • Study of Ivonescimab for Treating Relapsed Pleural Mesothelioma in Patients After Immunotherapy and Chemotherapy
  • Study on Talazoparib for Maintenance Treatment in Patients with Advanced Malignant Pleural or Peritoneal Mesothelioma After Initial Chemotherapy
  • Study of Volrustomig with Carboplatin and Pemetrexed for Patients with Unresectable Pleural Mesothelioma
• Germany
  • Study of Volrustomig with Carboplatin and Pemetrexed for Patients with Unresectable Pleural Mesothelioma
• Italy
  • Study of Pembrolizumab with Cisplatin or Carboplatin and Pemetrexed for Patients with Resectable Malignant Pleural Mesothelioma
  • Study of Tremelimumab for Patients with Unresectable Malignant Mesothelioma
  • Study of Volrustomig with Carboplatin and Pemetrexed for Patients with Unresectable Pleural Mesothelioma
  • Study on Atezolizumab for Patients with Malignant Pleural Mesothelioma After Surgery
• Netherlands
  • Study of Volrustomig with Carboplatin and Pemetrexed for Patients with Unresectable Pleural Mesothelioma
• Norway
  • Study of Nivolumab, Ipilimumab, and UV1 Vaccine for Patients with Malignant Pleural Mesothelioma After Initial Chemotherapy
  • Study of Volrustomig with Carboplatin and Pemetrexed for Patients with Unresectable Pleural Mesothelioma
• Poland
  • Study of Volrustomig with Carboplatin and Pemetrexed for Patients with Unresectable Pleural Mesothelioma
• Spain
  • Study of Nivolumab, Ipilimumab, and UV1 Vaccine for Patients with Malignant Pleural Mesothelioma After Initial Chemotherapy
  • Study of Volrustomig with Carboplatin and Pemetrexed for Patients with Unresectable Pleural Mesothelioma
• Sweden
  • Study of Nivolumab, Ipilimumab, and UV1 Vaccine for Patients with Malignant Pleural Mesothelioma After Initial Chemotherapy

Study of Intrapleural Photodynamic Therapy with Aminolevulinic Acid Hydrochloride and Nivolumab for Patients with Malignant Pleural Mesothelioma

This French trial is investigating a novel combination treatment approach for patients with unresectable malignant pleural mesothelioma. The study combines intrapleural photodynamic therapy delivered through video-assisted thoracoscopy with the immunotherapy drug Nivolumab.

Main inclusion criteria: Patients must be at least 18 years old with confirmed unresectable malignant pleural mesothelioma. They should have disease that has progressed after one or two lines of chemotherapy, or be patients who cannot or do not want chemotherapy. Participants must have an ECOG performance status of 0-1, meaning they can perform daily activities with little to no restriction. The disease must be measurable and suitable for local treatment with photodynamic therapy during thoracoscopy. Women of childbearing potential must use effective contraception and have a negative pregnancy test.

Main exclusion criteria: Patients with other serious health conditions that could interfere with the study cannot participate. Those who have had a different type of cancer in the past, unless it was treated and cured, are excluded. Pregnant or breastfeeding women, those with allergies to the study medications, and patients currently participating in another clinical trial are also excluded.

Focus and goals: The study aims to evaluate the safety and feasibility of combining photodynamic therapy with Nivolumab immunotherapy. Researchers will monitor how well the treatment controls the cancer, how long patients live without disease progression, and the treatment’s effects on quality of life. Blood samples and tumor biopsies will be collected to better understand how the treatment affects the body and to identify potential biomarkers.

Investigational drugs: Nivolumab is an immunotherapy drug administered as an intravenous infusion at 10 mg/mL. It works by blocking the PD-1 protein on immune cells, helping the immune system recognize and attack cancer cells more effectively.

Study of Ivonescimab for Treating Relapsed Pleural Mesothelioma in Patients After Immunotherapy and Chemotherapy

This French study is evaluating ivonescimab as a second or third line treatment for patients whose pleural mesothelioma has relapsed after previous immunotherapy and standard chemotherapy.

Main inclusion criteria: Participants must be 18 years or older with a confirmed biopsy diagnosis of pleural mesothelioma. They must show disease progression on CT scan after previous treatments and have measurable disease according to specific mesothelioma criteria. An ECOG performance status of 0 or 1 is required, along with adequate organ function including kidney, liver, and bone marrow function. Body weight loss must not exceed 10% in the last 3 months, and life expectancy must be more than 3 months. Available tissue samples from a previous biopsy are required, and women of childbearing potential must use effective contraception.

Main exclusion criteria: Patients with any other type of cancer besides pleural mesothelioma are excluded. Those who have received certain recent cancer treatments, have severe heart problems or uncontrolled high blood pressure, active infections requiring treatment, or are pregnant or breastfeeding cannot participate. Patients with a history of severe allergic reactions to similar medications or certain autoimmune diseases are also excluded.

Focus and goals: The trial will assess the therapeutic value of ivonescimab by evaluating the disease control rate at 12 weeks, progression-free survival, and overall survival. The treatment will be administered through intravenous infusion and monitored over a period of up to 24 months.

Investigational drugs: Ivonescimab is a bispecific antibody that targets two proteins: VEGF, which helps tumors grow new blood vessels, and PD-1, which can prevent the immune system from attacking cancer cells. By blocking both proteins simultaneously, ivonescimab aims to stop tumor growth while enhancing the immune response against cancer.

Study of Pembrolizumab with Cisplatin or Carboplatin and Pemetrexed for Patients with Resectable Malignant Pleural Mesothelioma

This Italian trial is investigating a preoperative treatment approach combining the immunotherapy drug pembrolizumab with standard chemotherapy for patients with resectable malignant pleural mesothelioma.

Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of surgical resectable stage I-IIIA treatment-naïve epithelioid or biphasic pleural mesothelioma. They must have an ECOG performance status of 0 to 1 and adequate lung function measured by specific tests. The diagnosis must be confirmed through tissue samples, preferably obtained through video-assisted thoracoscopic surgery. At study entry, complete surgical removal of the mesothelioma must be deemed possible by a multidisciplinary team. Patients must have measurable disease and provide adequate tumor tissue samples.

Main exclusion criteria: Patients with any other type of cancer besides malignant pleural mesothelioma or those outside the specified age range cannot participate. Those unable to receive the study medications or follow the treatment schedule are excluded, as are members of vulnerable populations.

Focus and goals: The study evaluates whether three cycles of combined pembrolizumab and chemotherapy given before surgery can reduce the cancer sufficiently to achieve a complete pathological response. The treatment will be given every three weeks, followed by surgical evaluation and potential resection. The study will monitor overall response rate, event-free survival, and overall survival.

Investigational drugs: The study uses pembrolizumab (an immunotherapy that helps the immune system recognize and attack cancer cells) in combination with either cisplatin or carboplatin (chemotherapy drugs that damage cancer cell DNA) and pemetrexed (a chemotherapy drug that disrupts cancer cell growth processes).

Study of Tremelimumab for Patients with Unresectable Malignant Mesothelioma

This Italian study is comparing tremelimumab to placebo in patients with unresectable malignant mesothelioma to determine if it can improve overall survival.

Main inclusion criteria: Patients must be 18 years or older with a confirmed diagnosis of pleural or peritoneal malignant mesothelioma that cannot be removed by surgery. They must have an ECOG performance status of 0-1 and have received 1-2 previous treatments for advanced disease, including first-line treatment with pemetrexed combined with a platinum agent. The disease must be measurable, and patients must have adequate bone marrow, liver, and kidney function. They must test negative for HIV and hepatitis A, B, and C.

Main exclusion criteria: Patients who have had another type of cancer in the past (unless unlikely to return), those with serious uncontrolled infections, pregnant or breastfeeding women, patients with immune system conditions, those taking immunosuppressive medications, patients with organ transplants, those with severe allergic reaction history to similar treatments, and patients with unstable brain, nervous system, heart, or lung conditions are excluded.

Focus and goals: The primary outcome is overall survival, defined as the time from randomization until death from any cause. Secondary outcomes include survival rate at 18 months, disease control rate, progression-free survival, and overall response rate. The study will run until June 30, 2025.

Investigational drugs: Tremelimumab is an immune checkpoint inhibitor administered intravenously. It works by blocking a protein called CTLA-4, which helps enhance the body’s immune response against cancer cells.

Study of Volrustomig with Carboplatin and Pemetrexed for Patients with Unresectable Pleural Mesothelioma

This multinational trial spanning Spain, Italy, Poland, France, Denmark, Belgium, Norway, Netherlands, and Germany is testing volrustomig in combination with carboplatin and pemetrexed for patients with unresectable pleural mesothelioma. The study compares this new combination to standard treatments.

Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of pleural mesothelioma of known type (either epithelioid or non-epithelioid). The disease must be advanced and cannot be removed by curative surgery. Patients must have a WHO/ECOG performance status of 0 or 1, with no worsening in the two weeks before starting treatment. The disease must be measurable using modified RECIST1.1 criteria, and patients must have adequate bone marrow function and properly working organs.

Main exclusion criteria: Patients with other serious health conditions that could interfere with the study, those who have had another type of cancer in the past (unless treated and cured for a certain period), pregnant or breastfeeding women, patients currently in another clinical trial, those with allergies to study drugs, patients with uncontrolled infections, those who received certain recent treatments, patients with drug or alcohol abuse history, those who had recent major surgery, and patients with certain uncontrolled heart conditions are excluded.

Focus and goals: The study aims to compare the effectiveness of different treatment combinations by assessing overall survival and progression-free survival. Additional assessments include response rate, duration of response, and safety evaluations.

Investigational drugs: The trial uses volrustomig (an investigational immunotherapy being studied for its potential to help the immune system target cancer cells), carboplatin (a chemotherapy drug that interferes with cancer cell DNA), pemetrexed (a chemotherapy medication that blocks cancer cell folate use), and in comparison groups, nivolumab and ipilimumab (immunotherapy drugs that help activate the immune system against cancer).

Study on Adding Atezolizumab and WT1/DC Vaccine to Standard Treatment for Patients with Epithelioid Malignant Pleural Mesothelioma

This Belgian trial is investigating whether adding atezolizumab and a WT1/DC vaccine to standard chemotherapy is safe and feasible for patients with epithelioid malignant pleural mesothelioma.

Main inclusion criteria: Patients must have signed informed consent and have confirmed epithelioid malignant pleural mesothelioma at any stage from I to IV. They must be 18 years or older with a WHO performance status of 0-1, meaning they are fully active or have some restrictions but can carry out light work. Adequate blood and organ function is required, along with negative viral serology for HIV, Hepatitis B, and Hepatitis C. Women of childbearing potential must have a negative pregnancy test at screening and be willing to follow the study protocol.

Main exclusion criteria: Patients with a different type of cancer, those who received certain interfering treatments, patients with serious health conditions making participation unsafe, pregnant or breastfeeding women, those unable to follow study procedures, patients with allergies to study medications, those in another clinical trial, patients who had recent major surgery, those with a history of certain infections, and patients with drug or alcohol abuse history are excluded.

Focus and goals: The study aims to determine if patients can complete the treatment schedule of four cycles of platinum/pemetrexed chemotherapy combined with four doses of atezolizumab and four WT1/DC vaccinations. It will evaluate safety, treatment effectiveness in controlling disease, survival rates, and immune response to the vaccine.

Investigational drugs: Atezolizumab is an immunotherapy drug administered intravenously that blocks the PD-L1 protein on cancer cells, helping the immune system attack them. The WT1/DC vaccine is given through intradermal injections and stimulates the immune system to target cancer cells expressing the WT1 protein. These are combined with standard platinum-based chemotherapy and pemetrexed.

Study on Neoadjuvant Chemotherapy and Immunotherapy with Ipilimumab, Pemetrexed, and Drug Combination for Patients with Inoperable Pleural Mesothelioma

This Belgian study is exploring whether a combination of chemotherapy and immunotherapy can make initially inoperable pleural mesothelioma suitable for surgery.

Main inclusion criteria: Patients must be able to provide written consent and follow study procedures. They must have confirmed pleural mesothelioma of the epithelioid type, staged as cT2-3 N0-1 M0 according to UICC TNM 9, considered inoperable by medical experts but potentially eligible for surgery if they respond well to initial treatments. Participants must be 18 years or older with a WHO Performance Status of 0-1 and be in good enough health to undergo systemic chemotherapy, immunotherapy, and surgery. Effective birth control is required to prevent pregnancy.

Main exclusion criteria: Patients with inoperable pleural mesothelioma that will remain inoperable cannot participate. Those outside the specified age range, not classified as T2-T3 according to TNM 9, or who are part of a vulnerable population requiring special protection are excluded.

Focus and goals: The trial evaluates whether two cycles of combined chemotherapy and immunotherapy can shrink tumors enough to allow surgery. It will monitor disease control, progression-free survival, overall survival, and quality of life. The treatment involves administering ipilimumab, pemetrexed, cisplatin, carboplatin, and nivolumab through intravenous infusion, followed by surgical evaluation.

Investigational drugs: The study uses neoadjuvant chemotherapy (treatment given before surgery to shrink tumors) and immunotherapy to enhance the body’s natural defenses. Specific drugs include cisplatin (a platinum-based chemotherapy agent that binds to DNA in cancer cells) and pembrolizumab (an immunotherapy that blocks the PD-1 pathway, allowing immune cells to attack cancer).

Study on Talazoparib for Maintenance Treatment in Patients with Advanced Malignant Pleural or Peritoneal Mesothelioma After Initial Chemotherapy

This French trial is testing talazoparib as a maintenance treatment for patients with advanced malignant pleural or peritoneal mesothelioma who have completed at least four cycles of initial platinum-based chemotherapy.

Main inclusion criteria: Patients must be older than 18 years with proper liver function (total bilirubin and ASAT/ALAT levels within specified limits) and a life expectancy of at least 16 weeks. Women of childbearing potential must confirm they are not pregnant and use effective birth control during treatment and for at least 7 months after finishing therapy. Men must use condoms during treatment and for at least 4 months after the last dose. Patients must provide written consent, be part of a social insurance program, and have an ECOG performance status of 2 or less. They must have confirmed malignant mesothelioma (epithelioid, sarcomatoid, or biphasic type) from pleura or peritoneum, previously treated with at least four cycles of platinum-based chemotherapy including pemetrexed, without disease progression during chemotherapy. The disease must be measurable or evaluable through CT scan, and tumor samples must be available.

Main exclusion criteria: Patients who haven’t completed at least 4 cycles of platinum-based chemotherapy or haven’t been diagnosed with advanced malignant pleural or peritoneal mesothelioma cannot participate. Those who are not adults or are part of a vulnerable population are also excluded.

Focus and goals: The study aims to see if talazoparib can keep the cancer from progressing for at least six months after starting treatment. Participants will be divided into three groups based on mesothelioma type and will be monitored with regular check-ups and tests to track their health and cancer status.

Investigational drugs: Talazoparib is an oral medication taken as 1 mg hard capsules. It works by inhibiting the enzyme PARP, which helps repair damaged DNA in cancer cells, thereby preventing them from growing and dividing. It is classified as a PARP inhibitor.

Study on Atezolizumab for Patients with Malignant Pleural Mesothelioma After Surgery

This Italian study is comparing atezolizumab to placebo in patients who have undergone pleurectomy/decortication surgery for malignant pleural mesothelioma, to determine if it can prevent disease recurrence.

Main inclusion criteria: Patients must be 18 years or older with a confirmed diagnosis of malignant pleural mesothelioma who have had pleurectomy/decortication surgery with no visible cancer remaining. They must have received at least 4 cycles of chemotherapy with platinum and pemetrexed (fewer cycles allowed if decided for clinical reasons). Patients who had chemotherapy before surgery must join within 50 days after surgery, while those who had it after surgery must join within 30 days of the last chemotherapy dose. An ECOG performance status of 0-1 is required, along with adequate organ function confirmed by lab tests within 14 days before starting treatment. One tumor sample from initial diagnosis must be provided.

Main exclusion criteria: Patients without malignant pleural mesothelioma, those outside the specified age range, patients not in the included clinical trial groups, and those who are part of a vulnerable population cannot participate.

Focus and goals: The primary goal is to assess disease-free survival, defined as the time from treatment start to first disease recurrence or death. The study will track safety and side effects, may include quality of life assessments, and is expected to conclude by December 13, 2027.

Investigational drugs: Atezolizumab is administered intravenously and works by blocking the PD-L1 protein on cancer cells, helping the immune system recognize and attack them. It is classified as an immune checkpoint inhibitor.

Study of Nivolumab, Ipilimumab, and UV1 Vaccine for Patients with Malignant Pleural Mesothelioma After Initial Chemotherapy

This multicenter study taking place in Denmark, Sweden, Spain, and Norway is investigating whether adding the UV1 vaccine to nivolumab and ipilimumab immunotherapy improves outcomes for patients with malignant pleural mesothelioma whose cancer has progressed after initial chemotherapy.

Main inclusion criteria: Patients must have a confirmed diagnosis of malignant pleural mesothelioma that cannot be removed by surgery. They must have at least one measurable tumor using CT or MRI scan and provide adequate tumor tissue samples. Participants must be 18 years or older with an ECOG performance status of 0-1, and agree to provide tumor tissue and blood samples for research. Adequate organ function is required, including hemoglobin of at least 9.0 g/dL, absolute neutrophil count of at least 1,500 per mm3, platelet count of at least 75,000 per mm3, serum bilirubin no more than 1.5 times normal limit, liver enzymes (AST and ALT) no more than 2.5 times normal limit (or 5 times if liver metastases present), and creatinine clearance greater than 40 mL/min. Patients must have previously received at least one line of platinum-based chemotherapy.

Main exclusion criteria: Patients without malignant pleural mesothelioma diagnosis, those who haven’t received first-line platinum-based chemotherapy, patients who had surgery to remove the cancer, those not experiencing cancer progression after initial treatment, and members of vulnerable populations cannot participate.

Focus and goals: The study will evaluate how long patients live without cancer progression (progression-free survival), overall survival rate, quality of life, and side effects. Participants will receive either nivolumab and ipilimumab with the UV1 vaccine or without it, over a period of up to 24 months.

Investigational drugs: Nivolumab is an intravenous immunotherapy that blocks the PD-1 protein on immune cells, helping them recognize and attack cancer. Ipilimumab is also given intravenously and targets the CTLA-4 protein on immune cells, enhancing the immune system’s ability to destroy cancer cells. Both are immune checkpoint inhibitors. The UV1 vaccine is administered as an injection under the skin and is designed to stimulate the immune system to target cancer cells by focusing on specific proteins found on these cells.

Study of WT1 LAMP mRNA DC Vaccine for Patients with Malignant Pleural Mesothelioma

This Belgian trial is investigating a novel vaccine therapy using dendritic cells modified with WT1 LAMP mRNA, combined with standard chemotherapy as a first-line treatment for malignant pleural mesothelioma.

Main inclusion criteria: Patients must have a confirmed diagnosis of epithelial malignant pleural mesothelioma and be 18 years or older with a WHO performance status of 0-1. They must be able to undergo general anesthesia and procedures including thoracoscopy (a procedure to look inside the chest), leukapheresis (white blood cell collection), chemotherapy, immunotherapy, and possibly pleurectomy/decortication surgery if the disease becomes operable. Patients must not have received investigational treatment within 28 days before joining and must not have a history of inability to tolerate pemetrexed or cisplatin. Written informed consent is required before study participation.

Main exclusion criteria: Patients with a different type of cancer than malignant pleural mesothelioma, those outside the specified age range, patients unable to receive standard chemotherapy treatment, those with medical conditions making it unsafe to receive study treatment, and patients unable to follow study procedures or attend required visits are excluded.

Focus and goals: The study will assess the feasibility and safety of the WT1 LAMP mRNA DC vaccine when used as first-line treatment combined with standard chemotherapy. It will evaluate how many patients can complete the treatment schedule and monitor treatment effectiveness in controlling disease, improving survival rates, and generating immune response. The vaccine is prepared from the patient’s own white blood cells collected through leukapheresis, then modified to target the WT1 protein commonly found in mesothelioma cells.

Investigational drugs: The WT1 LAMP mRNA dendritic cell vaccine uses the patient’s own immune cells modified with mRNA related to the Wilms’ tumor protein 1 to help the immune system recognize and attack cancer cells. It is given through intradermal injections and is designed to stimulate immune response against malignant pleural mesothelioma. This is combined with standard platinum-based chemotherapy.

Summary

The 11 ongoing clinical trials for pleural mesothelioma malignant reflect significant research activity focused on improving treatment options for this challenging disease. The trials are geographically distributed across Europe, with notable concentration in Belgium (3 trials), France (4 trials), and Italy (4 trials). Several trials are multinational, particularly the volrustomig study spanning nine countries.

A clear trend emerges toward immunotherapy-based approaches, with most trials investigating immune checkpoint inhibitors either alone or in combination with chemotherapy. Commonly studied drugs include nivolumab, pembrolizumab, atezolizumab, ipilimumab, and tremelimumab. Several trials are exploring novel bispecific antibodies and innovative vaccine approaches, including the UV1 vaccine and WT1-based dendritic cell vaccines.

The trials address different clinical scenarios: some focus on first-line treatment in treatment-naïve patients, others investigate maintenance therapy after initial chemotherapy, and several target patients whose disease has progressed after standard treatments. Two studies specifically examine post-surgical adjuvant therapy, while others investigate neoadjuvant approaches to make initially inoperable tumors suitable for surgery.

A notable innovation is the French trial combining photodynamic therapy with immunotherapy, representing a unique multimodal approach. Several trials incorporate biomarker research and quality of life assessments, reflecting comprehensive outcome evaluation beyond traditional survival metrics.

These diverse trials offer patients with different disease stages and treatment histories potential access to cutting-edge therapies, while advancing scientific understanding of how to most effectively treat this difficult-to-manage cancer.