Treating Melanoma Through Clinical Trials

Clinical trials are often viewed as the best treatment option for Stage II, III and IV melanoma patients, so it is important that you learn about them as a treatment option to help you make an informed treatment decision. All treatment options, including clinical trials, should be thoroughly discussed with your melanoma team. 

What is a clinical trial?

A clinical trial is carefully designed to closely monitor people’s progress as they go through treatment with an investigational drug, product, device or method of treatment that has not been approved by the FDA. Clinical research studies help find new ways to treat, prevent and diagnose diseases. Today, all medications prescribed by a doctor must first be tested in clinical research studies. Study participants receive close medical supervision and provide valuable feedback on their experiences.

All clinical research studies in the United States are reviewed by the FDA and governing bodies called institutional review boards, whose job is to make sure participants’ rights are fully protected and that participants are not exposed to any unnecessary risks.

All treatments must go through three phases of clinical research before becoming available to the public:

  • Phase I focuses primarily on safety in a small number of human volunteers
  • Phase II tests the effectiveness of the new drug on a small number of human volunteers
  • Phase III usually tests the new drug in comparison with the standard therapy currently being used on a larger number of human volunteers

Participating in a clinical trial is voluntary. Participants may choose to discontinue participation at any time. Before you enroll in a trial, a doctor or nurse will clearly explain the study procedures and requirements. This is called informed consent. Doctors are not allowed to enroll patients in clinical trials without first ensuring they understand what their involvement in the trial means. Once you enroll, you may end your participation at any time.

When participating in a clinical trial, participants receive study-related medications and medical monitoring at no cost. However, insurance requirements vary by study. Some may require insurance reimbursement for procedures with FDA approval for the treatment of melanoma and are used in conjunction with the investigational treatment (e.g., imaging scans or standard-of-care medications). Other studies, such as those conducted at the National Cancer Institute (NCI), provide all treatment at no cost. Most studies reimburse for travel and logistical considerations. It is important to find out the insurance requirements of the study in which you are considering participating.

Find Melanoma Clinical Trials

Are you looking for more information on clinical trials? It is important to discuss all treatment options, including clinical trials, with your melanoma treatment team, especially if you have been diagnosed with Stage II, III or IV melanoma. There are two ways you can learn more about available clinical trials, which centers of excellence are participating in clinical trials, and how to enroll in clinical trials:

1. The Melanoma Research Foundation's Clinical Trial Finder, hosted through our partner, EmergingMed, can provide you with a free, confidential, personalized service that helps you understand which trials may be an option for you. For best results, we recommend that you register and complete the profile information. This process helps ensure you are matched to the best possible trials for you. 

MRF Clinical Trial Finder

2. The NIH hosts, a world-wide clinical trial database provided by the U.S. National Library of Medicine. Be specific in your search terms to find the most helpful results.

Reasons to Consider a Clinical Trial

There are a number of reasons you or your doctor may want to consider participation in a clinical trial, including:

  • Access to investigational treatments before they become widely available
  • Opportunity to play a role in the discovery of treatments, cures and preventions for certain diseases or medical conditions
  • Ability to play a more active role in your own healthcare
  • Access to free physical examinations and diagnostic tests related to the study
  • In a survey by the Center for Information & Study on Clinical Research Participation (CISCRP), 95% of study volunteers would consider participating in another clinical trial

Common Myths About Clinical Trials

  1. Myth: If I enter a clinical trial, I'll be treated like a guinea pig.
    Fact: Entering a trial is always voluntary. You will have a detailed informed consent process and you can ALWAYS choose to stop participating. Many people like being on a clinical trial because they feel they are being monitored even more closely than before.
  2. Myth: I'm going to get a sugar pill (placebo) while other patients are getting actual medication.
    Fact: Studies will only use placebos when absolutely necessary. In 99% of cancer clinical trials, if a placebo is used, it is given with standard treatment. You will receive either the best known melanoma treatment OR a new and possibly more effective treatment. Most clinical trials provide either the best treatment option OR a new, and possibly better, treatment option. Many trials even combine the standard therapy with a new treatment.
  3. Myth: Clinical trials are too risky for me.
    Fact: All procedures that address a life-threatening illness pose some risk. Your physician and melanoma treatment team should help you decide if a clinical trial is the best treatment option for you. In a late stage melanoma diagnosis, clinical trials are often viewed the best treatment option. Keep in mind that all medications were once only available in clinical trials - even aspirin.