Mesothelioma Clinical Trials 2025: New Treatments & How to Enroll

What Are Clinical Trials?

Clinical trials are research studies that test new treatments, combinations, or approaches in human patients. For mesothelioma patients, clinical trials can provide access to treatments that are not yet widely available and may offer better outcomes than standard treatments.

Many of the most significant advances in mesothelioma treatment — including the 2020 FDA approval of immunotherapy (now the 2025 standard of care) — came from clinical trials.

Current Promising Trials (2025)

Active areas of mesothelioma clinical trial research include:

• CAR T-cell therapy — Engineering patients' own immune cells to target mesothelin, a protein overexpressed in mesothelioma
• Pembrolizumab (Keytruda) combinations — Testing checkpoint inhibitor combinations with chemotherapy
• Tumor treating fields (TTFields) — Using electric fields to disrupt cancer cell division
• Oncolytic virus therapy — Using modified viruses to selectively kill cancer cells
• BAP1-targeted therapy — Targeting the BAP1 gene mutation found in many mesothelioma cases
• Anti-mesothelin antibody-drug conjugates — Delivering chemotherapy directly to cancer cells

How to Find a Trial

The best resources for finding mesothelioma clinical trials include:

• ClinicalTrials.gov — The official U.S. government database of all registered clinical trials
• NCI Cancer Information Service — 1-800-4-CANCER
• Mesothelioma Applied Research Foundation — mesothelioma.org
• Your treating oncologist at a specialized mesothelioma center

Eligibility Criteria

Each trial has specific eligibility criteria. Common factors include:

• Mesothelioma type and cell type
• Stage of disease
• Prior treatments received
• Overall health and performance status
• Age and other medical conditions

Pros and Cons

Potential benefits:

• Access to new treatments before FDA approval
• Close monitoring by specialized medical teams
• Treatment costs often covered by the trial sponsor
• Contributing to research that helps future patients

Potential risks:

• Unknown side effects of experimental treatments
• Possibility of receiving a placebo (in some trials)
• More frequent medical visits required
• May need to travel to trial sites

Why Clinical Trials Matter for Mesothelioma Patients

Clinical trials are research studies that test new treatments or new combinations of existing treatments in human patients. For mesothelioma patients, clinical trials are particularly important because the standard treatment options — while improving — still offer limited survival benefits for most patients. Clinical trials provide access to promising new treatments that are not yet available outside of research settings, and participation in a trial may offer the best available treatment option for some patients.

The history of mesothelioma treatment illustrates the importance of clinical trials. The current standard first-line chemotherapy regimen — pemetrexed plus cisplatin — was established through clinical trials in the early 2000s. The immunotherapy combination of nivolumab and ipilimumab, approved by the FDA in 2020 and now the standard of care as of 2025, was established through the CheckMate 743 trial. Future advances in mesothelioma treatment will come from ongoing and future clinical trials. Patients who participate in trials today are contributing to the knowledge that will benefit future patients.

Types of Clinical Trials

Clinical trials are conducted in phases, each with a specific purpose. Phase I trials are the first studies in humans and focus primarily on safety — determining the maximum tolerated dose and identifying side effects. They typically involve small numbers of patients (15-30) and are open to patients who have exhausted standard treatment options. Phase II trials evaluate whether a treatment works and continue to assess safety. They involve larger numbers of patients (30-100) and may be open to patients who have received prior treatment or to newly diagnosed patients.

Phase III trials compare a new treatment to the current standard of care in large numbers of patients (hundreds to thousands). These are the trials that lead to FDA approval of new treatments. Phase IV trials (post-marketing studies) continue to evaluate a treatment after it has been approved, looking for long-term effects and effectiveness in broader populations. For mesothelioma patients, Phase II and Phase III trials are most relevant, as they offer access to treatments that have already shown some evidence of efficacy.

Current Areas of Research

Several areas of mesothelioma research are particularly active. Immunotherapy combinations — building on the success of nivolumab plus ipilimumab — are being investigated in numerous trials. Researchers are testing different checkpoint inhibitor combinations, combinations of immunotherapy with chemotherapy, and combinations of immunotherapy with radiation. CAR-T cell therapy, which involves engineering a patient's own immune cells to recognize and attack mesothelioma cells, is in early clinical trials and has shown promising results in some patients.

Targeted therapies — drugs that target specific molecular abnormalities in mesothelioma cells — are another active area of research. Mesothelioma frequently involves loss of the BAP1, NF2, and CDKN2A tumor suppressor genes, and drugs targeting the pathways affected by these losses are under investigation. Tumor-treating fields (TTFields), a non-invasive treatment that uses alternating electric fields to disrupt cancer cell division, has shown promise in combination with chemotherapy in the STELLAR trial and is being investigated further. Mesothelin-targeted therapies, including antibody-drug conjugates and vaccines, are also under investigation.

How to Find and Evaluate Clinical Trials

The most comprehensive database of ongoing clinical trials is ClinicalTrials.gov, maintained by the National Institutes of Health. Patients can search for mesothelioma trials by disease type, location, phase, and other criteria. The Mesothelioma Applied Research Foundation (MARF) and other patient advocacy organizations also maintain lists of ongoing trials and can help patients identify relevant options.

When evaluating a clinical trial, patients should consider several factors: the phase of the trial and what is known about the treatment's efficacy and safety; the eligibility criteria (many trials have specific requirements regarding prior treatment, performance status, and other factors); the practical requirements of participation (including travel to the trial site, frequency of visits, and time commitment); and the potential benefits and risks. A mesothelioma specialist can help patients evaluate whether they are appropriate candidates for specific trials and what the realistic expectations are.

Frequently Asked Questions