Melanoma
Clinical Trials
Every advance in melanoma treatment is the result of a clinical trial. Known as treatment trials, these research studies evaluate how well an intervention, such as a drug or combination of drugs, device, procedure, delivery system or strategy, works compared to the current standard of care. Along with having access to a treatment that otherwise may not be available, participants who volunteer for clinical trials are doing a great service. They are contributing to the future of cancer care.
As with any cancer treatment, those used in clinical trials present potential risks. Before you consider clinical trials as a treatment option, it is essential to learn about them so you can feel well-informed.
Safety
Clinical trials are designed with strict safety measures in place that were established and are enforced by the U.S. Food and Drug Administration. Although many trials are focused on the development of new treatments, the majority of cancer clinical trials include treatments that are already approved, sometimes alone and sometimes in combination with new therapies. Additionally, multiple guidelines and regulations are followed to ensure that all clinical trial participants are protected throughout the process. This is done through several levels of safeguards and a set of rules called a protocol. All participating clinics, hospitals, universities, cancer centers and medical offices, regardless of their size or location, must follow the same protocol.
From early-stage to metastatic melanoma, hundreds of melanoma trials are currently underway. Areas of research include identifying drug therapies to treat genomic mutations; evaluating the benefits of certain drug therapies used alone, in combination with other therapies or in a different order; treatment benefits and side effects of certain types of radiation therapy; treating metastatic melanoma; and vaccinations, among others.
Timing
Clinical trials are often thought of as a last-ditch effort, something that is tried only after all other treatments have failed. That is not true. Depending on the diagnosis, a clinical trial may be considered as a first-line treatment. If your doctor has not talked with you about clinical trials yet, bring it up. You deserve to know about all of your treatment options.
Searching for a Trial
Many clinical trials take place at the same time, making it difficult for your doctor to know about all of them. While your health care team is exploring potential trials, you can look for them online. Before you begin, have your exact diagnosis, pathology report and details of your current or prior cancer treatments on hand to help determine whether you meet the basic eligibility criteria. Then, start by using the list of clinical trial sites below. Your doctor may recommend additional sites. If you find a trial that interests you, discuss it with your health care team.
Location
You do not have to live near a major cancer center to be involved in a clinical trial. Actually, trials take place all around the country — in nationally known cancer centers in major cities, university medical centers, regional hospitals and even oncologists’ offices. And, thanks to advances in technology, many trials today use telehealth so you do not always have to travel for appointments or sign the Informed Consent form in person.
Informed Consent
If you find a trial, you will be given a document called Informed Consent. Informed Consent explains the protocol for that clinical trial in detail, including the trial’s eligibility criteria, the tests and procedures, the medications and dosages, possible side effects, the schedule to accommodate the tests and appointments that are required for the trial, and the length of the study. You will be asked to read and sign the Informed Consent form before moving forward with the trial. It is important to note that even after you sign and begin the trial, you can withdraw at any time, for any reason.
Great strides in treating melanoma continue to be made through these studies, and ongoing research is essential to learning more about prevention and a cure. Melanoma-focused clinical trials researching targeted therapies, immunotherapies, CAR T-cell therapy, vaccines and more are currently underway. Ask your doctor if you should consider a clinical trial at any time during your treatment.
Myths vs. Facts
Myths about clinical trials can easily influence a person’s decision when exploring this potential treatment option. See some myths debunked below.
MYTH: Participants may receive a placebo (“sugar pill”).
FACT: Placebos are rarely used in cancer clinical trials. Participants will never receive a placebo instead of treatment.
MYTH: Participants are treated like “guinea pigs.”
FACT: Most clinical trial participants report they had a good experience with clinical trials and felt they were treated with respect and dignity.
MYTH: Clinical trials are a last resort.
FACT: It is common for many people to feel this way, but trials today are open to patients at every stage of disease. Depending on the diagnosis, a clinical trial may be considered as a first-line treatment.
MYTH: The treatment cost of a clinical trial is not covered by health insurance.
FACT: Many insurers cover the normal costs of treatment in cancer clinical trials, and some states have mandatory coverage. And, Medicare covers most of the costs of care in a clinical trial.
