Metastatic Melanoma Clinical Trials: What You Need to Know
When you look at the numbers, it’s hard to believe: Five-year survival rates for metastatic melanoma have soared from 5% to 10% a decade ago to nearly 50% now. Such changes don’t happen naturally. One of the main drivers of increased survival rates? “Clinical trials,” says Pallavi P. Kumar, M.D., a medical oncologist and director of immuno-oncology at the MedStar Health Cancer Network in Baltimore. “Without the dedication of amazing scientists, doctors, medical staff, and patients, [melanoma] treatments like checkpoint inhibitors and targeted therapies would not be possible.” Learn more about clinical trials, including why you should consider taking part in one.
First Off, What Are Clinical Trials?
A clinical trial is medical research conducted in a study to evaluate something, be it new drugs, devices, surgery, or other therapeutic interventions. They’re often done to determine if these treatment options are effective—and have any side effects. They’re a key part of the U.S. Food and Drug Administration’s (FDA) approval process to get new treatments from research to the market, where you can access them. Important to note: In metastatic melanoma clinical trials, every participant receives real treatment; there are no placebo groups. These trials don’t focus on a cure; instead, they aim to help patients live longer or improve symptoms.
What Are the Phases of a Clinical Trial?
Clinical trials typically have at least three phrases to reach FDA approval, says Germame H. Ajebo, M.D., a clinical assistant professor of medicine, hematology/medical oncology, Georgia Cancer Center-Downtown at University Hospital in Augusta, GA, including: Phase I: Research examines the safety of a new treatment. Often conducted in small (20 to 80 people) groups. Phase II: Research focuses on the effectiveness of treatment and short-term side effects in a larger group (100-300). Phase III: Research expands, with more participants (several hundred to 3,000) yielding broader results. The FDA typically grants approval at this point. Phase IV: Research continues following approval.
Why Would I Take Part in a Clinical Trial for Metastatic Melanoma?
Ultimately, the best, and biggest reason, to take part in research for metastatic melanoma is to help push treatment advances forward, and raise the survival rate even higher, says Vadim Gushchin, M.D., a surgical oncologist, and director of The Melanoma and Skin Cancer Center, at Mercy Medical Center in Baltimore. It’s an act of generosity, helping provide better options to others who will one day walk the same path you are now. “Ten years ago, we didn't have this many drugs, and we have access to them only because of patients who did participate in clinical trials. It’s not the thing people think about when they are sick and scared, but the big picture is that, nonetheless.”
But Will I Get Access to Advanced Treatment?
People sometimes assume the major benefit of clinical trials is that the doctors involved use cutting-edge therapy, a way of accessing the best, most advanced treatment. But this isn’t usually correct, says Dr. Gushchin. “The majority of clinical trials fail to produce better treatment,” he says. Of oncology therapies in phase 1 trials, the probability of gaining later approval is 5%. A better benefit? You might get support from additional experts beyond your usual oncology team, he says, and perks including possible transportation to treatments, if needed. Still, because there are just a few drugs approved to treat metastatic melanoma, joining a clinical trial may offer more treatment options.
What Risks Should I Know About with Clinical Trials?
Even as clinical trials provide benefits for you as a patient, there are risks, too. The treatment might not work for you, it might not work better than (or even as good as) current treatment, it might have unexpected side effects. Clinical trials are reviewed by the FDA and governing bodies called institutional review boards (IRBs) to ensure your rights are protected and you’re safe. “Experts check all trials—before and during them—to make sure that they are safe for people to be in,” Dr. Ajebo says, but some risks remain.
How Do I Find a Clinical Trial?
Finding a clinical trial can be overwhelming, especially with everything else you’re likely dealing with as part of your metastatic melanoma diagnosis and treatment. One of your first resources can be your physicians, says Dr. Kumar. They can help you determine what treatment options currently in research might be the best options for you, given where you are in your diagnosis and treatment experience. For instance, someone who is recently diagnosed might qualify for different trials than someone having a recurrence. Your doctors can also let you know if their team, or the hospital they’re affiliated with, is taking part in any relevant research.
What Are Some Additional Resources for Clinical Trials?
If you’ve talked to your doctor about taking part in a clinical trial for metastatic melanoma and you’d like more info, take a look at what’s available online: ClinicalTrials.gov provides a search function to find studies listed by cancer type, so you can see the research happening right now for metastatic melanoma. Melanoma Research Foundation asks you to fill out a short questionnaire to identify clinical trials that fit your unique needs. You can also request a contact, or reach out by phone for more information. The National Cancer Institute offers helpful info about clinical trials.
Who Can Join Clinical Trials for Metastatic Melanoma?
When you do find a clinical trial for metastatic melanoma you want to take part in, it doesn’t mean you necessarily can. Each trial has a protocol, or a study plan. It includes eligibility criteria as well as what will happen during the trial. “In a metastatic melanoma clinical trial, the patient needs to have a biopsy-proven metastatic melanoma. Other rules might have to do with the patient’s age and whether they have any other medical conditions. To see if you can be in a trial, you might need to answer questions or have an exam or tests,” Dr. Ajebo explains.
What Should You Expect in a Clinical Trial?
First, the study staff will walk you through the trial’s requirements. “They will tell you about the trial, the benefits and downsides, and the tests and treatments,” Dr. Ajebo explains. If you want to take part, you’ll sign a consent form. If you meet study criteria, you’ll have a “baseline” first visit, then regularly see trial staff based on the study’s schedule, as well as your own doctor as needed. You usually don’t pay, but your insurance might be billed. You’ll need to follow the instructions of the trial, as well as tell your doctor about any side effects you experience. And don’t forget to give yourself kudos: You’re helping advance modern medicine.
Metastatic Melanoma Survival Rates: The ASCO Post. (2019). Long-Term Survival Outcomes with New Treatments for Advanced Melanoma: Questions Still in Need of Answers. ascopost.com/issues/october-25-2019/long-term-survival-outcomes-with-new-treatments-for-advanced-melanoma/
About Clinical Trials: National Institute on Aging. (2020). What Are Clinical Trials and Studies? nia.nih.gov/health/what-are-clinical-trials-and-studies
Why Take Part: BMC Cancer. (2020). “Are Cancer Patients Better Off If They Participate in Clinical Trials? A Mixed Methods Study,” ncbi.nlm.nih.gov/pmc/articles/PMC7206768/
Potential Risks of Clinical Trials: National Cancer Institute. (2020). Deciding to Take Part in a Clinical Trial. cancer.gov/about-cancer/treatment/clinical-trials/taking-part
Safety Checks for Clinical Trials: Melanoma Research Foundation. (2020). Treating Melanoma Through Clinical Trials. melanoma.org/patients-caregivers/clinical-trials/
How to Find a Clinical Trial: The American Cancer Society. (2020). Finding a Clinical Trial. cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/picking-a-clinical-trial.html
What to Expect in a Clinical Trial: Trials. (2019). “Patients’ Reasoning Regarding the Decision to Participate in Clinical Cancer Trials: An Interview Study,” ncbi.nlm.nih.gov/pmc/articles/PMC6162882/