What Are Mesothelioma Clinical Trials?

Clinical research trials offer the latest therapies before they become widely available. Researchers use clinical trials to investigate more effective treatments. They also improve screening and diagnosis methods and uncover new ways of preventing disease. As of April 2022, more than 124 clinical research trials are actively recruiting mesothelioma patients.

There are different types of clinical trials available, including:

  • Prevention Trials: Cancer prevention trials study ways to reduce cancer risk. Researchers work to discover if lifestyle changes or certain medications can prevent the onset of specific cancers.
  • Screening Trials: These studies look for better methods of finding cancer earlier in patients. By improving the way physicians find cancer, patients have more treatment options at the time of diagnosis.
  • Treatment Trials: Most studies test new mesothelioma treatments or novel combinations of existing therapies for better results. Cancer treatment clinical trials examine the safety and effectiveness of new drugs, procedures and multimodal approaches.

Cancer research trials often last several years. They go through many phases. Once recruitment starts, enrollment may be paused. These checkpoints are for researchers to analyze the data. If results are inadequate, the study sponsor may suspend or terminate the study early.

Mesothelioma Clinical Trials Actively Recruiting Patients

Dozens of clinical trials are recruiting mesothelioma patients. The U.S. National Institutes of Health maintains a database of past and present clinical trials for mesothelioma malignancy.

mesothelioma doctor at a cancer center can also help you access new treatments. Talk to your doctor about whether a clinical trial is right for you.

Active Mesothelioma Clinical Trials

Clinical Trial
Phase I Study of Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma

This study tests LMB-100’s safety and effectiveness as a direct tumor injection combined with ipilimumab as a new combination immunotherapy.

  • Condition: Malignant Mesothelioma
  • Intervention: Immunotherapy
  • Locations: Bethesda, Maryland
  • Recruiting: April 2021 – Present
Clinical Trial
Mesothelin-Targeted CAR T-Cell Therapy in Patients with Mesothelioma

This study tests the safety of MSLN-targeted CAR T-cells to find the safest dose to give to people with malignant pleural mesothelioma. It is the first study of its kind in people.

  • Condition: Pleural Mesothelioma
  • Intervention: CAR T-Cell Therapy
  • Locations: New York, New York
  • Recruiting: October 2020 – Present
Clinical Trial
Poly-ICLC (Hiltonol) Vaccine in Malignant Pleural Mesothelioma

This study examines the safety and effectiveness of poly-ICLC directly injected into malignant pleural mesothelioma during biopsy before the surgical removal.

  • Condition: Pleural Mesothelioma
  • Intervention: Poly-ICLC (Hiltonol) Vaccine
  • Locations: New York, New York
  • Recruiting: August 2020 – Present
Clinical Trial
Durvalumab with Chemotherapy as First-Line Treatment in Advanced Pleural Mesothelioma (DREAM3R)

Patients in this study receive first-line treatment with standard chemotherapy of pemetrexed and cisplatin. Two-thirds of participants will also receive durvalumab immunotherapy.

  • Condition: Pleural Mesothelioma
  • Intervention: Chemotherapy
  • Locations: Baltimore, Maryland; Ann Arbor, Michigan; St. Louis Park, Minnesota; Cleveland, Ohio
  • Recruiting: April 2020 – Present
Clinical Trial
A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

This study will test giving nivolumab with pemetrexed and either cisplatin or carboplatin before surgery and whether it is a safe and effective approach without delaying surgery.

  • Condition: Malignant Mesothelioma
  • Intervention: Chemotherapy
  • Locations: New Jersey; New York
  • Recruiting: November 2019 – Present
Clinical Trial
Neoadjuvant Immune Checkpoint Blockade in Resectable Malignant Pleural Mesothelioma

This study will evaluate the safety and feasibility of neoadjuvant and maintenance nivolumab with and without ipilimumab in pleural mesothelioma patients eligible for surgery.

  • Condition: Pleural Mesothelioma
  • Intervention: Nivolumab With and Without Ipilimumab
  • Locations: Baltimore, Maryland; Houston, Texas
  • Recruiting: April 2019 – Present
Clinical Trial
A Pilot Window-Of-Opportunity Study of the Anti-PD-1 Antibody Pembrolizumab in Patients with Resectable Malignant Pleural Mesothelioma

This study is a pilot trial of pembrolizumab before and after surgery in patients with resectable malignant pleural mesothelioma.

  • Condition: Pleural Mesothelioma
  • Intervention: Pembrolizumab
  • Locations: Chicago, Illinois
  • Recruiting: March 2016 – Present
Clinical Trial
SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma

This first-in-human trial is designed to assess the safety, feasibility and potential activity of a single IV dose of SynKIR-110 administered to subjects with mesothelin-expressing advanced ovarian cancer, mesothelioma and cholangiocarcinoma.

  • Condition: Malignant Mesothelioma
  • Intervention: Immunotherapy
  • Locations: Philadelphia, Pennsylvania
  • Recruiting: April 2023 – Present
Clinical Trial
A Phase I Study of IAG933 in Patients With Advanced Mesothelioma and Other Solid Tumors

The purpose of this study is to characterize the safety and tolerability of IAG933 in patients with mesothelioma, NF2/LATS1/LATS2 mutated tumors and tumors with functional YAP/TAZ fusions and to identify the maximum tolerated dose and/or recommended dose.

  • Condition: Malignant Mesothelioma
  • Intervention: Immunotherapy
  • Locations: Boston, Massachusetts
  • Recruiting: March 2023 – Present
Clinical Trial
Stereotactic Body Radiation Therapy With Immunotherapy for the Treatment of Mesothelioma

This phase I trial studies the effect of stereotactic body radiation therapy and immunotherapy in treating patients with mesothelioma.

  • Condition: Malignant Mesothelioma
  • Intervention: Radiation, Immunotherapy
  • Locations: Rochester, Minnesota
  • Recruiting: February 2023 – Present

How Clinical Trials Can Help Mesothelioma Patients

Clinical trials can be a valuable resource for mesothelioma patients. They offer access to promising new treatments. These therapies may not be available through standard treatment options. 

These trials are testing new treatments. Examples include experimental drugs that target specific proteins or pathways in cancer cells. Immunotherapy trials harness the power of the patient’s immune system to fight cancer.

By participating in a clinical trial, mesothelioma patients can benefit from these new treatments. They may help to improve their prognosis and quality of life. Experimental drugs, for example, can provide a targeted approach to treating cancer. Targeted drugs attack specific molecular pathways. These pathways are involved in the growth and spread of the tumor.

In some cases, clinical trials may offer the chance for patients to receive a combination of experimental therapies. These combinations have been shown to be effective in early studies. This approach can be particularly beneficial for mesothelioma patients. The disease often requires a multimodal therapeutic approach to achieve the best outcomes.

I want to be as helpful as I can. Being in a clinical trial has allowed me to do that, providing information to researchers about therapies that could help patients in the future. Sure, I was hoping it could help me, but it’s also rewarding when you know you’re helping others, which is what a clinical trial does.
Mesothelioma survivor

Are Clinical Trials for Mesothelioma Safe?

Clinical trials always come with certain risks. The experimental treatment may not be as effective as anticipated. You could experience unexpected side effects that harm your health.

A mesothelioma clinical trial can last weeks, months or years. The time depends on the trial’s goal, the number of patients involved and the results. Most drugs have to pass through multiple phases of trials. It can take years before getting U.S. Food and Drug Administration approval.

  • Phase I: A phase I trial involves the smallest number of people, perhaps only a few dozen participants. It focuses on making sure the experimental therapy is safe. The goals are to analyze side effects, examine how the drug or procedure is processed by the body, and determine safe dosage levels.
  • Phase II: A phase II trial takes a closer look at the effectiveness of the new treatment for specific types of cancer while determining the safest dosage or technique of the therapy. The trial population may include up to a few hundred patients.
  • Phase III: Phase III trials measure the effectiveness of the new treatment using randomization and blinded groups versus the conventional treatment approach. Randomized trials with blinded components involve the physician and patient not knowing whether the trial drug or a placebo is given.
  • Phase IV: After a drug clears the first three phases, a drug developer can file an application to market the new drug. Even after the FDA has approved a new therapy, a phase IV trial may be required. This phase ensures effectiveness after approval for commercial use for specific indications.
Participation of patients with mesothelioma in clinical trials is essential if we are going to make progress and develop novel therapies.
Senior investigator at the NCI

How Successful Are Clinical Trials for Mesothelioma?

Not all patients will find success during a mesothelioma clinical trial. However, every patient in a clinical trial receives, at minimum, the current standard of care. Experimental therapy doesn’t always work. In that case, physicians discuss other options with their patients. 

If a trial is unsuccessful for most patients, the investigators will discontinue the study. Many factors determine effectiveness. These include treatment type, medical history and adverse effects. Successful mesothelioma clinical trials lead to more extensive studies and approved treatments. 

For example, a 2019 study published in The Lancet Oncology tested a combination of nivolumab and ipilimumab immunotherapy. The study found that 52% of pleural mesothelioma patients who received the combination had disease control for 12 weeks. For comparison, less than 30% of pleural mesothelioma patients achieved disease control in previous studies of second-line drugs. 

The success of this trial led to the FDA approval of Opdivo and Yervoy immunotherapy for pleural mesothelioma patients in October 2020. Studies like these help researchers determine which treatments have the potential as safe and effective new therapies. 

In 2023, researchers confirmed a new phase II study is underway investigating the synergistic effect of gavocabtagene autoleucel (gavo-cel). The researchers are testing gavo-cel with Opdivo and Yervoy. In early phase I results, 93% of patients experienced tumor regression. 

What Are the Risks Associated With Mesothelioma Clinical Trials?

There are risks involved when trying a new therapy. Researchers understand these risks and set protocols to avoid them, such as closely monitoring patients for signs of toxicity and side effects. Mesothelioma clinical trials are designed to prioritize patient safety. 

Potential participants should consider the possible inconvenience. There is a traveling and time commitment in addition to potential side effects of treatment. The new treatments are still being tested. It is uncertain if they will be effective at treating mesothelioma.

Participating in a clinical trial can be emotionally challenging. It may involve uncertainty and the possibility of negative outcomes. Discuss the risks and benefits of joining a clinical trial with your doctor and your family.

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Mesothelioma Clinical Trials Lead to New Treatments and Better Survival Rates

There is no cure for mesothelioma. Doctors are researching new therapies to improve survival rates and quality of life.

Sometimes a clinical trial results in a breakthrough. It can change the way doctors approach cancer treatment. For example, research studies led to FDA approval of the first mesothelioma chemotherapy option. They also led to the more recent Tumor Treating Fields.

Chemotherapy Trial of Cisplatin and Alimta

In 2003, one of the most important mesothelioma clinical trials announced its success. They study treated patients with a combination of the chemotherapy drugs Alimta (pemetrexed) and cisplatin. In 2004, the combination therapy was approved by the FDA to treat pleural mesothelioma.

Tumor Treating Fields (TTFields) Clinical Trial

Clinical trials led to the May 2019 FDA approval of Tumor Treating Fields. Together, chemotherapy and TTFields control the growth of pleural mesothelioma. The results of the trial that led to FDA approval showed an improved overall survival of more than six months.

This emphasizes the importance of patient participation. Many mesothelioma trials struggle to get enough participants to truly test a new drug or therapy. Joining a trial helps researchers get closer to developing a cure for mesothelioma.

Survivor Stories from Mesothelioma Trial Participants

The stories of mesothelioma trial participants attest to the life-changing potential of clinical trials.

Mesothelioma Survivor

Kathy A. joined a clinical trial in 2013 that halted the growth of her tumors for six months. In 2014, she underwent chemotherapy but had to stop after a year because of side effects. Now she’s looking for another clinical trial to join.

“I’m not sure what I’m going to do if or when the doctor tells me the cancer is growing again,” Kathy said. “That’s why I wanted to find another clinical trial. Chemotherapy alone isn’t the answer.”

Richard M.
Mesothelioma Survivor

Richard M. joined an immunotherapy clinical trial in 2012 after his surgery for pleural mesothelioma. He believes the immunotherapy trial helped extend his survival, although now he copes with reduced stamina.

“I want to be as helpful as I can,” Richard said. “Being in a clinical trial has allowed me to do that, providing information to researchers about therapies that could help patients in the future. Sure, I was hoping it could help me, but it’s also rewarding when you know you’re helping others, which is what a clinical trial does.”

How Do I Enroll in a Clinical Trial for Mesothelioma?

Most patients enroll in trials at the recommendation of their doctor. They generally know which clinical trials their patient may be eligible to join.

Cancer centers and clinics participating in research trials will typically have staff dedicated to running clinical trials. A research coordinator may reach out if you meet eligibility requirements.

Every mesothelioma clinical trial has specific criteria for who is eligible to participate. Some trials are only for patients who have not been treated before. Other trials are exclusively for patients who did not respond well to standard treatments.

Steps to Enroll in a Clinical Trial

Step 1: Talk to Your Doctor

Your oncologist can recommend clinical trials tailored to your diagnosis and medical history.

Step 2: Get a Second Opinion

Seek a second opinion from a mesothelioma specialist. It may open the door to other clinical trials.

Step 3: Which Trials Interest You?

Take the time to completely understand the trials that most appeal to you. Review and discuss the research trial information with your family. Together, you can determine if the trial expectations and stress may be too much to bear.

Step 4: Ask Questions and Finalize Your Decision

Ask your doctor as many questions as necessary to understand the risks and benefits of the trial. Once you’ve finalized your decision, your medical team will walk you through the necessary paperwork to begin the screening process.

Common Eligibility Factors of Clinical Trials

After you enroll in a clinical trial, research personnel will conduct a series of blood and imaging tests. These extra precautions ensure that you are eligible for the study. They also ensure that the experimental treatment won’t cause extra harm. Some requirements include patients who have metastatic cancer. Others may specify no prior therapy.

Examples of clinical research eligibility criteria include:
  • Ability to comply with instructions and treatment protocol
  • Absence of cardiac issues or chronic illnesses
  • Additional eligibility for cancer surgery
  • Adequate overall health and performance status
  • Adequate white and red blood cell counts
  • No major recent treatments
  • No recent participation in other clinical trials
  • Presence of specific tumor biomarkers
  • Previous treatment with a particular type of therapy
  • Tumor cell types confirmed via biopsy

Questions to Ask Your Doctor Before Participating

Prior to enrolling, it is important for a mesothelioma patient to fully understand the details and purpose of the trial.

Questions for Your Doctor and Trial Sponsors
  • What is the specific goal of this trial?
  • Are there other treatment options I should consider first?
  • What are the costs?
  • What are the possible side effects?
  • Will I have to change my daily activities?
  • Am I allowed to take my usual medications and supplements in this trial?

View & Print These FAQs About Clinical Trials

We’ve created a list of additional questions you can print and take with you to your doctor visit or hospital offering the clinical trial.

Getting answers to these concerns will help you and your loved ones. Together, you can decide if participating in a clinical trial is best for you. If you think of any other questions, be sure to ask them. Request clarification if you feel the doctor or researcher did not sufficiently answer your questions.

Dr. Jacques Fontaine and Dr. Virginia Wolf
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Other Common Questions About Mesothelioma Clinical Trials

How do I find out about mesothelioma clinical trials?

Talk to your doctor about which trials are available in your area. You may search online databases, such as ClinicalTrials.gov, and a Patient Advocate can help you understand how to find mesothelioma trials that you qualify for.

Will I have to pay to participate in a mesothelioma clinical trial?

Many clinical trials cover all or part of the therapies used in clinical trials, but each trial varies. Certain therapies, such as traditional chemotherapy, are often covered by health insurance.

Where do I find a mesothelioma clinical trial?

You can learn more about mesothelioma clinical trials from your doctor, in addition to researching them online at ClinicalTrials.gov. You can also speak with a Patient Advocate to find a clinical trial that might be right for you.

Can mesothelioma be cured through clinical trials?

Unfortunately, there is no cure for any stage or type of mesothelioma, and no clinical trial has led to a cure for a patient with mesothelioma. However, many patients have lived years longer than their original prognosis thanks to joining a clinical trial. Some patients respond abnormally well to certain therapies and end up benefitting more than most patients. This isn’t the norm, but there is hope that joining a clinical trial could add years to your life.

Are placebos used in cancer clinical trials?

Placebos are not common, but they are sometimes used in cancer trials in combination with conventional treatment, experimental treatments or when no conventional treatment exists. Researchers are never allowed to intentionally withhold necessary medical care. You will not miss out on high-quality medical care by participating in a clinical trial.

Can I withdraw from a mesothelioma clinical trial?

Yes, participants in clinical trials have the right to withdraw from the study at any time. You should notify your doctor if you decide to withdraw from the trial.