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Karen Selby:
Is a Mesothelioma Clinical Trial Right for You?
A mesothelioma clinical trial might be the best first-line treatment option depending on your mesothelioma case. Your care team may suggest a trial because your cell type fits a high-volume program, because you need a second-line option after standard treatment stops working or because an early-phase trial is testing a new drug.
Before you commit to a mesothelioma clinical trial, you need to know why your team recommends it and how it compares to your standard-of-care options. Asking detailed, specific questions when you sit down with the trial team can prepare you for important conversations and help you decide whether a trial is right for you.
Why is this trial being recommended to me right now?
A mesothelioma clinical trial can be offered as first-line care in earlier stages of a mesothelioma diagnosis or as an alternative to standard treatment. Ask your doctor why a clinical trial is suggested for your treatment plan. Factors in your mesothelioma diagnosis like your cell type, staging and treatment history may influence your eligibility for clinical trials.
Has my case been presented to a mesothelioma tumor board, and what did they recommend?
A mesothelioma tumor board brings oncologists, radiologists, pathologists and mesothelioma specialists together to review your case. For a rare cancer like mesothelioma, this multi-specialty input can clarify the details of your diagnosis and develop a treatment plan based on recommendations from multiple specialists.
If your case was presented to a tumor board, clarify with your doctor when the board met, who was in the room and what they recommended. If your case hasn’t been presented to a board, you can request your case be reviewed with your doctor or seek a second opinion at a National Cancer Institute-designated cancer center.
“Mesothelioma, I think it’s really important to be presented in a tumor board. What does that mean? Not just your regular tumor board. Every hospital pretty much has a tumor board where you have different sets of doctors that just weigh in on your cancer diagnosis about what to do. Your tumor board only means something if it’s from specialists in radiology, radiation oncology, medical oncology, thoracic surgery, pulmonology, that have expertise in mesothelioma.”
Dr. Jeffrey Velotta
If I don’t join this trial, what is my standard-of-care plan and what are its expected outcomes?
Your standard-of-care options depend on your staging and progression of mesothelioma. Typically, patients diagnosed with stages 1 or 2 have more treatment options than patients diagnosed at stages 3 or 4. In some instances, your doctor may suggest a trial in addition to standard care.
Ask your doctor to describe each of your treatment options with response rates, expected timelines and side effect profiles. Your doctor can explain the expected outcomes of each option, and you can review with your family and loved ones to decide which treatment plan to pursue.
Am I Eligible for This Mesothelioma Clinical Trial?
Mesothelioma trial eligibility depends on your cell type (epithelioid, sarcomatoid or biphasic), your treatment history and your current organ function. Getting clarity on your eligibility early saves time and helps your care team match you with the trial that best fits you.
Do my mesothelioma cell type and location affect whether I qualify?
Eligibility for each clinical trial is different. Many mesothelioma clinical trials enroll only patients with epithelioid cell type, which tends to respond better to chemotherapy. Patients with sarcomatoid or biphasic mesothelioma often have fewer mesothelioma treatment options available.
The location of the mesothelioma also matters. Patients with peritoneal mesothelioma could have access to hyperthermic intraperitoneal chemotherapy, Pressurized Intraperitoneal Aerosol Chemotherapy and immunotherapy trials. Patients with pleural mesothelioma tend to see more surgical, immunotherapy and tumor treating fields. Your trial team can name the specific cell type and mesothelioma type the trial accepts and confirm your eligibility through recent pathology reports and recent imaging.
Other medical diseases may be considered when looking into eligibility for a clinical trial for mesothelioma. Any heart, kidney, liver function and autoimmune diseases may change your eligibility for a trial.
Will prior surgery or treatments exclude me from participating in a clinical trial?
Treatment history is one of the most common eligibility filters in mesothelioma clinical trials. Second-line trials often require prior platinum-based chemotherapy. Most first-line trials require patients who haven’t yet had chemotherapy. Surgical history is also a factor in trial eligibility.
Velotta notes, “The MARS 2 trial was patients either had chemotherapy alone, and then were followed to see if whether or not they died or had recurrence, versus chemotherapy first and then you got surgery. When they compare those two groups, it turns out that the chemotherapy-alone group lived longer by several months versus the chemotherapy group followed by surgery. But just to know that there are some inconsistencies with it, we shouldn’t just go based on that trial.”
What is the screening process, what records should I bring and how long until I know if I’m eligible?
Screening typically includes consent, labs or imaging and, in some cases, a tissue re-biopsy. Bring your pathology report, operative records, full treatment history, recent CT or PET imaging and a current medication list to the first screening.
Most trial teams take 2 to 4 weeks to determine your trial eligibility. Your team can provide specific dates and locations for each screening step, a list of which records in your existing chart can and cannot be used and a named contact for logistics questions.
How Does a Mesothelioma Clinical Trial Work and Who Runs It?
A mesothelioma clinical trial has a structure and a team. The structure includes a phase, a goal, randomization rules and a visit schedule. The team includes a Principal Investigator, a trial coordinator, a sponsor and an institutional review board.
Principal Investigator vs. Trial Coordinator
Principal Investigator: A credentialed physician, typically a medical or surgical oncologist, who designs or runs the trial at the site. The PI sees you at screening and milestone visits and signs off on dose changes and serious side effect decisions. Ask how many mesothelioma patients they’ve personally enrolled in trials.
Trial Coordinator: A nurse or clinical research coordinator who is your day-to-day point of contact. The coordinator schedules visits and labs, fields questions and communicates with insurance and the sponsor. Ask for a named coordinator with a direct line at your first screening visit, plus a backup contact.
What is the specific goal of this trial? What phase is it in? Could I receive a placebo?
Some clinical trials measure overall survival, while others measure progression-free survival, response rate or quality of life. The trial phase tells you where the research stands. Phase 1 tests safety and dosing, Phase 2 tests effectiveness at the chosen dose and Phase 3 compares the treatment to standard care. Pure-placebo trials are rare in mesothelioma. Ask your doctor about the primary endpoint and goal of your trial, the phase number and the specific treatment groups in the trial.
“Although there’s no cure, what happens is that we treat it either with surgery or chemotherapy or immunotherapy, and that cancer goes into remission. If the cancer comes back, then we have the next type of treatment we can offer. But by then, one of our clinical trials, one of our experimental trials, has been shown to be very beneficial. And now it’s FDA-approved, and we can use it. We knock it on the head again. And that’s how the weeks become months to become years of good quality of life, not being cured of the mesothelioma, but living with mesothelioma.”
Dr. Jacques Fontaine
Who is the principal investigator and trial coordinator, and how do I reach them after hours?
The principal investigator is the credentialed physician who oversees the clinical trial. Your PI may be an oncologist, but they may not specialize in mesothelioma. If you are apprehensive about participating in the clinical trial with your PI, you can get a second opinion from a doctor or a mesothelioma specialist.
The trial coordinator is your real day-to-day contact for the trial. You can get their name, direct number and email at the first screening visit, plus a backup contact for when they’re out. To reach your PI or get other trial information, your coordinator can gather this information for you.
What will my schedule look like during the trial, and how long will active treatment last?
Ask your trial team how many visits to expect per cycle, how long each visit runs, how often scans happen and whether port placement is part of the protocol. You can then align your clinical trial visits with your current treatment plan.
Active treatment timelines vary. A Phase 1 trial might last a few months while a Phase 3 trial can run 2 years or more. After active treatment ends, follow-up scans can continue for another 2 to 5 years, even if the disease is stable. When discussing active treatment or follow-ups, ask whether your visits can happen close to home or require travel.
Connect with top-rated doctors specializing in mesothelioma treatment, who will personalize treatment options based on your diagnosis.
Find Your DoctorSafety, Informed Consent and Your Right to Withdraw From a Trial
Voluntary participation is the foundation of every mesothelioma clinical trial. You can withdraw at any time, for any reason, and the trial team should help with the transition back to standard care. You have the right to understand everything before you sign a consent form.
Can I take the consent form home, and what should I ask if there’s something I don’t understand?
You can almost always take your consent form home, and you can ask questions about anything you don’t understand. Regulators require informed voluntary consent for trial participation. Ask for 24 to 72 hours to review the form with your primary oncologist, a family member or a Patient Advocate. You can contact your PI or trial coordinator if you have follow-up questions.
What are the known risks and side effects of this trial’s treatment?
Immunotherapy trials have risks that may include inflammation of the lungs, bowel or liver complications and hormone gland problems. Ask your trial team about the most likely side effects associated with your trial, including their frequency and severity.
You should also ask about the team’s plan for catching problems early. This can indicate how often labs are run, how symptom check-ins work and what the decision process looks like if side effects become serious.
If I want to stop, can I withdraw? What happens to my care, my tissue samples and my insurance coverage if I leave the trial?
Participation in clinical trials is always voluntary. You can withdraw at any time for any reason with no penalty. In the event that you stop participating in the trial, confirm the trial team will send a transition note to your original oncologist and share your most recent records and imaging. Ask which trial-covered procedures will revert to your insurance after you leave. Confirm what will happen to your tissue and blood samples after you have exited the trial. Also, ask whether you’ll continue to receive new safety findings and whether re-enrollment in the same or a future trial may be possible.
Costs, Coverage and Logistics of a Mesothelioma Clinical Trial
A mesothelioma clinical trial involves financial, logistical and medical commitments. Knowing the cost of mesothelioma treatment before you sign on helps you and your family plan.
What does the sponsor cover, what does my insurance cover and what will I pay out of pocket?
Under the Affordable Care Act, most insurance plans must cover routine patient care costs in approved clinical trials. Medicare covers routine costs of qualifying clinical trials. The trial sponsor typically covers the experimental drug, study-specific labs, scans and procedures.
The gray area is where surprise bills come from. Some items fall between what the sponsor covers and what insurance considers routine. Request an item-by-item cost breakdown, with a coordinator’s commitment to flag any potential uncovered costs before they happen. Ask for the trial’s identification number from ClinicalTrials.gov to give your insurer when you call and budget for deductible resets if the trial lasts longer than your insurance coverage year.
Be sure to ask whether the sponsor reimburses travel, lodging and meals. Also, look into whether leave protected under the Family and Medical Leave Act applies to your situation.
If I’m a veteran or eligible for asbestos trust fund compensation, can those cover trial-related costs like travel and lost wages?
The U.S. Department of Veterans Affairs runs trials at several major medical centers across the country. If a veteran is enrolled in VA health care and was exposed to asbestos during service, they may qualify for VA-covered trials. Asbestos trust fund payouts are unrestricted compensation. The amount you receive may cover travel, lodging, lost caregiver wages and out-of-network care that insurance won’t touch. The claims process can take 6 to 18 months, so it’s worth starting early. A good trial team knows these pathways exist and can work with your VA benefits counselor or claims attorney.
Where is the trial conducted, how much travel will I do and what happens if I miss a visit?
Some mesothelioma clinical trials run at a single site, where all visits, labs and scans take place. Others are multi-site, meaning visits may occur at one location and labs and follow-up scans occur at another. One of those sites may even be your home oncologist’s office.
Add travel time into your schedule. Each trial has a different policy on missed visits. Ask your trial team about its missed-visit policy and plan ahead with a family member or Patient Advocate.
Speak with a dedicated Patient Advocate for answers about treatment, doctors, and financial help.
Talk to an AdvocateOther Common Questions About Mesothelioma Clinical Trials
- Does insurance cover mesothelioma clinical trial participation?
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Most insurance plans must cover routine patient care costs in approved clinical trials under the Affordable Care Act. Medicare covers routine care portions of Phase 2 and 3 trials. Self-insured and grandfathered plans may not. Ask for the trial’s identification number from ClinicalTrials.gov to give your insurer.
- Will I get a placebo in a mesothelioma clinical trial?
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Pure-placebo trials are rare in mesothelioma. Most Phase 3 trials compare an experimental treatment to standard care, not to a placebo. Some trials are blinded, meaning neither you nor your care team knows which treatment you’re receiving during the study. Others are open-label, meaning everyone knows. The trial consent form explains the comparison treatment in detail.
- Can I withdraw from a clinical trial after I start?
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Yes. Clinical trial participation is always voluntary. You can withdraw at any time, for any reason, and the trial team can send a transition note back to your original oncologist. Before you leave, ask what happens to your tissue and blood samples and which procedures will revert to your insurance coverage. Ask whether you’ll continue to receive new safety findings after you withdraw.
- Are veterans eligible for VA-covered mesothelioma clinical trials?
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Veterans exposed to asbestos during service may qualify for VA-covered trials at major VA medical centers.
- Where are mesothelioma clinical trials located?
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A clinical trial’s location depends on where the trial is being studied. Mesothelioma is a rare cancer and it can be difficult to find enough patients for a trial at each individual hospital. A Patient Advocate can help find clinical trials in your area and verify your eligibility.
