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Mesothelioma Clinical Trials

Mesothelioma clinical trials give patients access to innovative therapies and new approaches not yet approved by the U.S. Food and Drug Administration (FDA). For example, some studies test combination strategies pairing surgery with other mesothelioma treatment options — options that are not currently FDA-approved but may improve outcomes.

Medically reviewed for accuracy by

Dr. Stephen Williams

Precision Oncology Scientist

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What Is a Clinical Trial?

A clinical trial is a carefully designed study to test a new therapy or treatment approach for diseases such as cancer. Trials are the foundation of medical advancements, serving as the testing ground for different therapies that eventually could become the standard of care for patients.

Clinical trials are typically offered through leading cancer centers and top hospitals. When a patient is diagnosed, their doctor may discuss enrolling in a clinical trial, either at their hospital or another specialized center, as one of the available options for treatment.

One of the most important aspects of clinical trials is accessibility and affordability. In many cases, patients do not have to pay for the experimental treatment being tested. This not only opens the door to potentially lifesaving care but can also save patients and their families tens of thousands of dollars in medical costs.

Clinical trials for mesothelioma focus on:

Cancer treatment – Exploring new drugs, surgery techniques, or combination therapies.
Prevention – Studying ways to reduce the risk of developing mesothelioma.
Screening – Testing improved methods for early detection of the disease.
Diagnosis – Developing more accurate diagnostic tools.
Supportive care – Identifying strategies to improve quality of life during treatment.

KEY TERMS IN CLINICAL TRIALS

Placebo-Controlled – Some participants receive the experimental treatment, while the others receive a placebo (a pill or treatment that looks the same but contains no active medication).
Randomized – Participants are assigned to groups by chance, ensuring the results are unbiased.
Double-Blind – Neither the participants nor the researchers know who is receiving the experimental treatment or drug, preventing bias in the results.

Who Benefits From Clinical Trials for Cancer?

Clinical trials can benefit patients at different stages of cancer, though they are often most valuable for those with advanced disease. Patients with stage 3 or stage 4 cancer are frequently offered a spot in a clinical trial, especially when surgery is no longer an option and standard FDA-approved therapies provide only limited survival benefits.

However, clinical trials are not just for late-stage patients. Many phase 1 and phase 2 studies specifically enroll patients with early-stage cancers (stages 1 and 2). Researchers often seek patients with better overall health and stronger survival chances to evaluate how new therapies perform under optimal conditions and help the therapy perform well to progress it to larger studies.

Basic Information About Clinical Trials for Mesothelioma

Mesothelioma clinical trials are medical studies used to test new treatment approaches for this disease. Clinical trials give hope, especially to people diagnosed with mesothelioma. Doctors and researchers use mesothelioma clinical trials to investigate, and hopefully prove, the effectiveness and safety of new advanced treatment methods.

FDA APPROVAL FOR CLINICAL TRIALS

The end goal of these studies is to receive approval from the FDA to make a specific treatment a standard of care for this cancer. These treatment investigations can include:

New drugs or combinations of drugs (testing safety and efficacy)
Combinations of different therapies (like combining chemotherapy and immunotherapy)
Quality-of-life and mental health evaluations (to improve coping skills to manage stress, anxiety, and depression)
Supportives methods (to help patients manage symptoms and improve quality of life)
New or improved diagnostic testing (to identify and diagnose mesothelioma earlier)

One of the benefits of mesothelioma specialists and cancer centers is their ability to connect patients with clinical trials. Mesothelioma treatments and diagnostic procedures in use today have gone through clinical testing to ensure quality and safety.

The testing process, from concept to FDA approval, is lengthy. Medical breakthroughs for mesothelioma may exist, but they are not yet formally approved.

Benefits of Mesothelioma Clinical Trials

If you have been diagnosed with mesothelioma, enrolling in a clinical trial may provide you an opportunity to receive new treatments still being studied. Most participants of mesothelioma clinical trials have already been used to approve standard mesothelioma treatment options and are seeking additional therapeutic options. Strict regulations and procedures control these trials to ensure patient safety.

New treatments may come in the form of radiation, chemotherapy, immunotherapy, new drug combinations, virotherapy, or multimodal therapy that includes surgery. Clinical trials may someday help patients achieve long term remission and even cure mesothelioma.

You can learn more about clinical trials in our free Mesothelioma Guide.

Clinical Trial Process for Mesothelioma

Before a medication or treatment for mesothelioma can be approved by the FDA, it must go through a series of clinical trial phases to ensure it is both safe and effective. Most pass through at least three phases, with some continuing into a fourth phase for long-term monitoring.

Phase 1

Safety and Dosage

Phase 1 clinical trials for mesothelioma test a new treatment in a small group of participants. The goals are to determine:

Whether the treatment is safe to use
Maximum tolerated dose
Potential side effects
The most effective dosage
The best method of administration (pill, liquid, IV, or suppository)

According to the FDA, phase 1 trials typically last several months and enroll fewer participants than later phases. This stage provides the foundation for developing future studies.

Phase 2

Effectiveness

Phase 2 clinical trials for mesothelioma focus on the effectiveness of the treatment. Researchers focus on:

How the treatment affects mesothelioma at the tumor site
The tumor response (whether the cancer shrinks, stabilizes, or continues to grow)
The overall response within the patient population

According to the FDA, phase 2 trials can take up to two years to complete.

Phase 3

Comparison to Standard Treatment

Phase 3 clinical trials for mesothelioma are often the final step before FDA approval. In this phase, researchers compare the new treatment to current standard therapies, evaluating:

Whether the new treatment provides greater benefits
Disease response and long-term safety

Participants are usually randomized into two groups: one receives the new therapy, and the other receives standard treatment (the control group). This allows researchers to directly compare outcomes. Phase 3 trials may take up to four years to complete.

Phase 4

Post-Approval Monitoring

Phase 4 clinical trials for mesothelioma are defined as post-approval studies, meaning the FDA has already approved the treatment for general patient use. These studies are designed to monitor the new treatment for long-term safety, effectiveness, and optimal use.

Researchers will evaluate how the treatment performs in larger, more diverse populations over time. There is no set timeline for completion of this phase, as ongoing observation is often required.

Kendra Ferreira

Peritoneal Mesothelioma Survivor

KENDRA FERREIRA: MESOTHELIOMA SURVIVOR

Kendra Ferreira was first diagnosed with peritoneal mesothelioma in 2001. She quickly realized that treatment options for her rare cancer were very limited. Finding a mesothelioma specialist was a crucial step in accessing the most effective care. The expert guided her toward an aggressive clinical trial that included surgery followed by chemotherapy. Thanks to that groundbreaking surgery and subsequent treatment – nearly 20 years later, Kendra remains a mesothelioma survivor.

“I was fortunate to be accepted into a clinical trial and I believe it saved my life,” she said.

You could be the next mesothelioma survivor providing hope to other mesothelioma patients. Read more stories of survival in our free Mesothelioma Survivors Guide book.

How to Enroll in a Clinical Trial for Mesothelioma

Participation in a clinical trial is voluntary and requires informed consent. Before enrollment, patients receive comprehensive information about the study’s purpose, procedures, risks, and potential benefits from their doctor. Those who agree to participate will sign a consent form. Patients may choose to leave the trial at any time if they no longer wish to continue.

Patient Considerations

Clinical trials have specific enrollment criteria. Patients must meet these criteria to participate and are individually evaluated using test-related specifications:

Age

Certain trials may test a treatment on a specific age group (example: 45-55). This disqualifies anyone older or younger than the specified age range.

Gender

Certain studies may only apply to women (example: dual treatments targeting ovarian cancer and peritoneal mesothelioma). Other trials may use male hormones that would exclude women.

Current health

The current or past health of a patient may determine whether certain trials accept them. Some trials will exclude patients with particular medical conditions or histories.

Mesothelioma type and/or stage

Certain trials focus on a specific mesothelioma type or stage (example: stage 2 pleural mesothelioma).

Past treatment

Some studies exclude patients — or look to enroll patients — who have already undergone a specific treatment (example: surgery, chemotherapy, or radiation). Studies may exclude patients who have already participated in a similar study (example: a previous immunotherapy study).

Candidacy for future surgery

Many studies may exclude or enroll patients based on whether they are candidates for surgery.

Patients are accepted or denied based on these qualifications. There are many ongoing clinical trials for mesothelioma. If a patient is rejected from one trial, they should still apply to others.

Placebo-Controlled Mesothelioma Clinical Trials

Some people hesitate to enroll in clinical trials due to use of control groups and placebo-controlled trials.

In placebo-controlled trials, half the participants receive the drug being tested, while the other half receive a “placebo.” The placebo is a pill that looks identical to the actual drug but doesn’t contain any medicine. Those who get the placebo are chosen randomly, making the study “randomized.” A “double-blind” trial means neither the doctors nor the participants know who got a placebo.

Understanding your options and how these studies help may alleviate concerns.

Why Are Placebos Used?

Placebos allow researchers to compare outcomes directly. This helps them quickly determine whether the experimental drug is truly effective. Without a placebo group, it would be difficult to measure if improvements are due to the drug itself or other factors.

Why Randomization and Double-Blind Methods Matter

Prevents bias in how results are recorded and interpreted
Ensures fairness — Every participant has the same chance of receiving the experimental treatment
Produces more reliable results that the FDA and medical community can trust

Patient Safety Comes First

Participants in placebo-controlled trials are closely monitored by top specialists. If a patient’s condition worsens, their doctor will intervene, discuss options, and ensure the patient’s well-being comes first. Patients always retain the right to leave a trial at any time.

Deciding Whether to Join

Choosing to participate in a placebo-controlled trial is a personal decision. For many patients — especially those who have already tried standard therapies — clinical trials may represent the best opportunity to access new treatments and extend survival. Speaking with a patient advocate or mesothelioma specialist can help you weigh your options and find the trial that’s right for you.

Sources & Author

What Are the Phases of Clinical Trials? American Cancer Society. Retrieved from:
https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html. Accessed: 09/30/2025.
Step 3: Clinical Research. U.S. Food and Drug Administration. Retrieved from: https://www.fda.gov/patients/drug-development-process/step-3-clinical-research. Accessed: 10/02/2025.

About the Writer, Devin Golden

Devin Golden is the senior content writer for Mesothelioma Guide. He produces mesothelioma-related content on various mediums, including the Mesothelioma Guide website and social media channels. Devin's objective is to translate complex information regarding mesothelioma into informative, easily absorbable content to help patients and their loved ones.