Medically Reviewed by: Dr. Zoe Owrutsky, PhD | January 23rd, 2026
Clinical trials play a critical role in advancing cancer care by testing new therapies, medications, and emerging treatments before they become widely available. For patients diagnosed with mesothelioma, participating in a clinical trial may provide access to innovative cancer care approaches, such as immunotherapy. Many active trials are currently recruiting patients nationwide and helping researchers improve outcomes and quality of life for future patients.
Clinical trials are experimental studies that test new cancer treatments, medications, and therapies using patient volunteers before they become widely available. Clinical trials use groups of patient volunteers to test the safety and efficacy of new medications, treatments, prevention methods, and more. A clinical trial may take place in hospitals, doctors’ offices, community clinics, or universities. Some trials are conducted at multiple locations across the country or around the world.
The primary goal of clinical trials is to improve patients’ quality of life and, ultimately, to find more effective treatments and potential cures. In the United States (U.S.), clinical trials are overseen by the Food and Drug Administration (FDA) and are conducted in four main phases. Each is designed to answer specific questions about a treatment’s safety, dosage, and effectiveness.
A principal investigator (usually a medical doctor) leads a team of physicians, nurses, and other healthcare professionals throughout each phase of a trial.
Clinical trials for mesothelioma have led to advances in surgical techniques, improved radiation methods, and the development of new chemotherapy drugs. As of 2026, more than 100 active mesothelioma clinical trials are recruiting patients. This includes studies evaluating new immunotherapy combinations, targeted therapies, and newer approaches, such as photodynamic therapy. These trials may offer potential benefits to patients who have not responded to standard treatment options, while also helping extend survival and quality of life. For example, phase 3 clinical trial data supported FDA approval of the immunotherapy combination nivolumab plus ipilimumab as a first-line treatment for unresectable malignant pleural mesothelioma, providing a new standard option for patients.
Understanding the purpose of each phase of a clinical trial can help patients know what to expect when considering participating in a study. For new treatments to receive approval, a drug or procedure typically moves through three or four primary phases. The fourth phase may continue for years after approval to monitor long-term safety and effectiveness under the oversight of the FDA.
Many studies also include preclinical (laboratory) research, where drugs are tested on cells or animals before being introduced to humans. In some cases, a phase 0 study may occur prior to phase 1 clinical trials. These early studies often involve fewer than a dozen participants and very small drug doses. Phase 0 studies are not required in clinical trials.
Phases |
Goal |
Description |
|
I (1) |
Confirm treatment is safe to treat the condition. |
Typically includes 15 to 30 patients and focuses on determining safe dosage levels and how the body processes treatment. In mesothelioma trials, this phase may evaluate the safety of new immunotherapy approaches, such as CAR T-cell therapy. |
|
II (2) |
Determine how well treatment works (or doesn’t work). |
These trials involve a larger group of participants to assess how effectively a treatment produces the desired outcome, such as tumor shrinkage or symptom relief, while continuing to monitor side effects. |
|
III (3) |
Compare efficacy to currently available treatments. |
Phase 3 clinical trials often enroll several hundred patients and compare the new treatment to the standard of care. For mesothelioma, this may include testing a new drug combination or surgical approach against established chemotherapy regimens. |
|
IV (4) |
Study long-term uses, side effects, and reactions. |
After FDA approval, this phase monitors the treatment’s effects in thousands of patients over several years to uncover long-term side effects, outcomes, and overall quality-of-life impacts. |
Each phase has specific eligibility requirements. This means that a patient’s diagnosis, prior treatments, and overall health can determine which mesothelioma clinical trials may be appropriate to pursue.
Clinical trials are carefully regulated to protect patient safety and ensure ethical treatment. Before a study can begin, it must be reviewed and approved by an institutional review board (IRB). This is an independent committee that includes medical experts and community representatives. The role of the IRB is to make sure that the trial is designed fairly, risks are minimized, and participants’ rights and well-being are protected and prioritized.
In addition to IRB oversight, many clinical trials are monitored by data safety boards that review results as the study progresses. Government agencies, including the FDA and Office for Human Research Protections (OHRP), also have the authority to oversee how trials are conducted. Mesothelioma clinical trials are closely monitored due to the seriousness of the disease and the advanced treatments often being tested.
Before enrolling, a member of the research team will explain the purpose of the study to you, including potential risks and benefits, and available alternative treatments. You will be asked to sign an informed consent form to confirm that you understand the trial and your rights. An informed consent form isn’t a contract, as you can still choose to drop out of the study at any time, for any reason.
Before enrolling in a mesothelioma clinical trial, it’s important to fully understand what participation involves. Patients are encouraged to ask questions at any point, before, during, or after a study, to make informed decisions about their care. Below is a list of questions to ask to help you learn more about participating in a mesothelioma clinical trial:
Despite the potential risks, clinical trials can greatly improve the quality of life, particularly for mesothelioma patients who have not responded to standard treatments. Clinical trials can also lead to major breakthroughs in diagnostic procedures and emerging treatments for mesothelioma patients in the future (such as immunotherapy drugs).
Patients who wish to enroll in clinical trials can start by speaking with their mesothelioma specialist or connecting with a patient advocate, who can help identify appropriate studies based on diagnosis, treatment history, and overall health. Your patient advocate can help determine which trials match your diagnosis and treatment history. ClinicalTrials.gov is also a reliable resource for finding active mesothelioma clinical trials that are currently recruiting patients.
Many trials cover some or all treatment-related costs, and some may also provide reimbursement for travel, lodging, or other expenses. In addition, certain studies now offer decentralized or hybrid participation options, allowing patients to complete some visits remotely or at local healthcare facilities. Many cancer centers also have clinical trial coordinators who assist with eligibility screening, enrollment, and next steps in the process.
In some cases, a patient may not meet the clinical trial eligibility requirements but could still benefit from advanced treatment options. While experimental drugs are typically only available through clinical trials, certain patients may qualify for compassionate use, also known as expanded access. This option allows seriously ill patients to receive unapproved medications when no other treatments are available, including those who live far from trial locations or do not meet enrollment criteria.
In addition, some emerging treatments may be available off-trial through specialized cancer centers. Talk with your mesothelioma specialist or contact a patient advocate to determine whether compassionate use or other options may be available to you.
If you’ve been diagnosed with mesothelioma, you may be eligible for compensation to help cover treatment and care costs. Learn more about your legal options.
Medical research is constantly evolving, and oncologists (cancer doctors) continue to explore new ways to treat, manage, and improve outcomes for patients with mesothelioma. Advances in targeted therapy, immunotherapy, and multimodal treatment approaches have expanded options for patients with both early- and late-stage disease.
Below are examples of active mesothelioma clinical trials as of 2026.
| Clinical Trial Name | Phase | Cancer Type |
| Chemotherapy with or without Immunotherapy for Peritoneal Mesothelioma | II | Malignant peritoneal mesothelioma |
| Nivolumab and Ipilimumab in Treating Patients With Rare Tumors | II | Epithelial cell tumors, squamous cell carcinomas, and adenocarcinomas of the respiratory tract |
| Sacituzumab Govitecan for the Treatment of Patients with Diffuse Pleural Mesothelioma | II | Diffuse pleural mesothelioma |
| MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma | III | Pleural mesothelioma |
| A Study of NX-1607 in Adults With Advanced Malignancies | I | Primary peritoneal and fallopian tube carcinoma, gastric cancer, recurrent and metastatic or unresectable melanoma, non-small cell lung cancer, metastatic prostate cancer, malignant peritoneal mesothelioma, triple-negative breast cancer, advanced or metastatic urothelial cancer; cervical cancer, colorectal cancer, diffuse large B-cell lymphoma |
| Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors | I/II | Metastatic or unresectable malignant mesothelioma (pleural and non-pleural) |
These are representative examples as of 2026. Visit ClinicalTrials.gov for complete and up-to-date listings.
More than 100 active mesothelioma clinical trials are currently recruiting patients across various disease stages, treatment histories, and mesothelioma subtypes.
Zoe earned her Bachelor of Science from the University of Pittsburgh in 2014 and her Ph.D. in neuroscience from the University of Colorado Anschutz Medical Campus in 2023. As a neuroscience researcher, she studied the pathophysiology of depression and schizophrenia and worked toward developing translational biomarkers for spatial hearing ability. She is passionate about mental health advocacy and science communication.