Mesothelioma Clinical Trials

What Is a Clinical Trial?

Clinical trials are medical studies involving people. These medical studies investigate and help improve several aspects of mesothelioma cancer:

• Diagnosis: Researchers test new technologies for making it faster and easier to diagnose mesothelioma.
• Treatment options: Doctors try new treatments to determine their safety and efficacy, sometimes leading to medical breakthroughs.
• Quality of life: Researchers study whether new interventions can help mesothelioma patients manage symptoms and feel better day to day.

Clinical trials are highly regulated to protect patients and the integrity of results. Researchers must follow stringent regulations enforced by the federal government.

Each clinical trial is also overseen by an Institutional Review Board (IRB). The IRB is composed of doctors, scientists and other people who work to protect trial participants. The IRB reviews the study plan before the trial begins and monitors the study while it runs. It evaluates whether risks are minimized and reasonable in relation to potential benefits.

Finding Clinical Trials for Mesothelioma

Patients can discuss clinical trials with their medical care team. An experienced mesothelioma doctor may know which trials are recruiting and which may fit the patient’s case.

Patients do not need to wait until other treatments stop working to ask about clinical trials. Some trials require patients to have received no prior treatment.

Mesothelioma Clinical Trials by Status

Explore current and past mesothelioma clinical trials by recruitment status:

• Recruiting: These studies are actively recruiting new patients who meet the trial criteria.
• Active – not recruiting: These studies are ongoing but have stopped enrolling patients. If the treatment being studied is not yet FDA approved, it is usually not available outside the trial. In some cases, a doctor can request access through the FDA’s expanded access program. Patients should ask their oncologist whether this is an option.
• Completed: These studies have finished. Doctors will review the data from completed trials and often publish it in medical journals.

_{Note: Clinical trial information is provided by ClinicalTrials.gov.}

Other Places to Find Clinical Trials

Patients can also research clinical trials on their own. There are a variety of online resources that provide clinical trial information, including:

• ClinicalTrials.gov (database of worldwide clinical trials)
• National Cancer Institute (NCI’s searchable list of cancer clinical trials)
• Specific cancer center websites (e.g., The University of Texas MD Anderson Cancer Center’s Clinical Trials page)

These resources can help patients check whether a trial is recruiting, active but not recruiting or completed. Patients can then ask their doctor whether they may be eligible for a recruiting trial.

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What Happens When You Participate in a Clinical Trial?

Once a patient decides to pursue a clinical trial, the process typically includes the following steps:

1. Checking eligibility: The study team first checks whether the patient appears to meet the trial’s requirements, including whether any exclusion criteria apply. Common eligibility requirements include a specific stage of mesothelioma and activity level (performance status).
2. Providing informed consent: All clinical trial patients must understand the details and risks of the trial. This information will be provided in writing. Study organizers will get a signed confirmation that the patient has received and understands the study information. This confirmation will also include consent by the patient to be treated according to the study protocol. If the patient is uncomfortable with any details from the informed consent, they can decline to participate in the trial.
3. Undergoing preliminary tests and providing a medical history: Many clinical trials start with doctors running blood or imaging tests on mesothelioma patients. These tests help confirm whether the patient meets all eligibility criteria and provide baseline information that helps researchers understand the study results. Patients will also provide a medical history and may undergo a physical examination. These steps help protect patient safety.
4. Receiving treatment according to the study protocol: The patient will undergo the treatment prescribed by the study. In some clinical trials, patients are randomly assigned to different treatment groups. They may receive a new treatment or the current standard treatment. During or after treatment, the patient may have more blood tests or imaging studies done. These help researchers monitor the patient’s progress and potential side effects. Patients should report all side effects to their physician or study coordinators. Researchers may be able to treat or minimize these side effects.
5. Following patient progress after treatment: Researchers will continue monitoring patients for the duration of the study, even after treatment has stopped. This may involve office visits or telephone interviews.

Every patient's experience with a clinical trial is different, and participation does not guarantee that a treatment will be effective. Patients should remember that study participation is voluntary at all times. Even after signing the informed consent or receiving treatment, patients can drop out of the study for any reason.

Mesothelioma Clinical Trial Phases and Costs

Clinical trials follow different phases to evaluate new treatments before and after FDA approval. Understanding these phases and the potential costs of participating can help mesothelioma patients make informed decisions about joining a trial.

Phases of a Mesothelioma Clinical Trial

Most new cancer drugs go through phase I, phase II and phase III trials before the U.S. Food and Drug Administration (FDA) decides whether to approve them. Phase IV trials take place after approval.

Each phase of a clinical trial answers a different question:

• Phase I: Doctors conduct phase I trials with a small group of patients to evaluate the safety of a new treatment. Doctors usually study dosage levels, side effects and how the body metabolizes the drug.
• Phase II: Doctors study the treatment with a larger group of people to evaluate its efficacy. Phase II trials are sometimes used to compare treatments with existing treatments or rarely placebos. Promising efficacy can then lead to phase III trials.
• Phase III: Phase III trials typically compare a new treatment with an existing treatment in a large group of patients. The results help researchers evaluate its effectiveness and safety and may support FDA approval.
• Phase IV: In some cases, treatments are approved but continue to be studied. Doctors study details of long-term use in this phase. The treatment may also be studied in populations not included in earlier phases.

Mesothelioma Clinical Trial Funding and Costs

Clinical trials are often funded by the government or drug companies. Trial sponsors may pay for the treatment being studied and for tests done only for research. Most private health plans are required to cover routine patient care costs during qualifying clinical trials. Medicare and Medicaid also provide coverage, although coverage rules and out-of-pocket costs vary.

Insurance often covers routine patient care costs during a trial, including:

• Doctor visits
• Hospitalizations
• Imaging (X-rays or MRI scans)
• Laboratory tests
• Standard cancer treatments
• Treatments to improve side effects

Out-of-pocket costs can include copays or deductibles. Additional fees may also arise with out-of-network care.

In addition to some coverage limitations, patients should keep other potential fees in mind. Deciding to pursue a clinical trial could require travel and housing expenses. For some patients, travel may require paying for a caretaker to watch loved ones during treatment.

Some trials will provide travel and housing stipends for patients who need to travel significant distances to participate. Patients may also find grant programs or other options to help cover additional costs of participating in a clinical trial.

Before enrolling, patients should ask the study coordinator and their insurance provider which costs are covered.

Did You Know? Some effective treatments are available for mesothelioma that insurance does not cover. Financial assistance is available to mesothelioma patients. Learn More About Financial Assistance Available

Questions to Ask Your Doctor About Clinical Trials

Before enrolling in a mesothelioma clinical trial, patients should discuss the potential benefits, risks and practical considerations with their doctor. Asking questions about the treatment, eligibility requirements, costs and follow-up care can help patients decide whether a trial is right for them.

Below are some questions to ask your doctor:

• What is the purpose of the clinical study?
• Why do you think this trial may be a good fit for me?
• How are study results and safety being monitored?
• How long will the study last?
• What kinds of tests and treatments does the study involve, and how does that compare to standard treatment?
• What are the potential benefits, risks and side effects if I participate?
• What other options do I have?
• Will I be able to take my regular medications during the study?
• Does this treatment require travel to a cancer center?
• What are the associated costs, and will insurance cover them?
• Will I have to be hospitalized? If so, how often and for how long?
• Will I receive long-term follow-up care as part of the study?
• Is this trial randomized, and could I receive standard treatment instead of the new one?
• If I am harmed as a result of the research, what treatment would I be entitled to?
• If the treatment helps me, can I keep receiving it after the trial ends?

Taking notes during the appointment or bringing a family member along can help patients remember the answers and weigh their options.

Mesothelioma Treatments and Clinical Trial Results

Researchers are continually working to improve mesothelioma treatment through clinical trials. Various studies have demonstrated the value of this mesothelioma cancer research. Some studies have led to new standard treatments that help patients live longer. Other studies have compared palliative care options to see which work best.

More details on these and other finished studies are on our Clinical Trials – Completed page.

Types of Treatments Tested in Mesothelioma Clinical Trials

Clinical trials test a variety of treatments for both pleural mesothelioma and peritoneal mesothelioma. Some trials focus on combining treatments such as surgery and radiation therapy. Other studies have investigated specific chemotherapy combinations for patients with inoperable (unresectable) mesothelioma.

One such trial tested the chemotherapy drugs Alimta® (pemetrexed) and cisplatin for first-line treatment of pleural mesothelioma. The combination of drugs extended survival by about three months versus cisplatin alone.

Since 2020, immunotherapy has become a standard first treatment for pleural mesothelioma that cannot be removed with surgery. Phase III trials led to this change. Current trials are testing newer approaches. These include CAR T-cell therapy, antibody-drug conjugates and drugs that target certain gene changes. Many of these newer treatments are still being tested in early-phase (phase I or phase II) trials.

Some peritoneal mesothelioma trials study chemotherapy or immunotherapy given before or after cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC).

CheckMate 743 and KEYNOTE-483 | Immunotherapy as a First Treatment

Two phase III trials changed how doctors treat pleural mesothelioma that cannot be removed with surgery. Both compared an immunotherapy-based treatment with chemotherapy alone in patients who had not been treated before.

In CheckMate 743, patients who received Opdivo® (nivolumab) plus Yervoy® (ipilimumab) lived a median of 18.1 months. Patients who received chemotherapy lived a median of 14.1 months. The FDA approved this combination in October 2020. Five-year results published in 2026 showed that 14% of patients who received Opdivo plus Yervoy were alive after five years, compared with 6% of patients who received chemotherapy.

In KEYNOTE-483, patients who received Keytruda® (pembrolizumab) with Alimta and platinum chemotherapy lived a median of 17.3 months. Patients who received chemotherapy alone lived a median of 16.1 months. The FDA approved this combination in September 2024.

These results come from large groups of patients. Some patients live much longer than the median. Others do not respond to immunotherapy.

Understanding Antibodies and Immunotherapy

Antibodies are a part of the immune system. An antibody is a protein that helps immune cells recognize and attack foreign material. Keytruda (pembrolizumab), Opdivo (nivolumab) and Yervoy (ipilimumab) are antibody-based immunotherapy drugs. These drugs help the immune system attack and kill mesothelioma cells.

STELLAR Trial | Electric Fields to Fight Mesothelioma

This study investigated a novel device in patients with inoperable pleural mesothelioma. The device, the Optune Lua™, creates Tumor Treating Fields (TTFields). TTFields are mild, wave-like electric fields capable of interfering with tumor cell growth. TTFields may even kill cancer cells.

In the STELLAR trial, pleural mesothelioma patients received chemotherapy and TTFields treatment. Median overall survival in the trial was 18.2 months, which researchers described as “encouraging.” STELLAR was a single-arm trial of 80 patients. It did not directly compare TTFields with chemotherapy alone. The FDA approved the device for this use in 2019 through a humanitarian device exemption.

MesoVATS | Comparing Treatments for Pleural Effusion

This study evaluated two treatment options for pleural effusion caused by pleural mesothelioma. Pleural effusion is a condition in which fluid collects in between the two layers of the pleura (lining around the lung).

Some patients received talc pleurodesis, a procedure that seals the two layers of the pleura together. Other patients underwent video-assisted thoracoscopic partial pleurectomy (VAT-PP). VAT-PP is a minimally invasive surgery that removes part of the pleura. The goal of both procedures is to keep pleural effusion from coming back.

Survival at one year was similar with both procedures. Talc pleurodesis led to fewer complications and shorter hospital stays, so researchers concluded it may be the preferable option. VAT-PP did improve quality of life at some points during follow-up.