Moderna Clinical Melanoma Trial – The Fresh Toast

Participants must not have:

• Any other cancer in the past 5 years
• Any medical treatments for melanoma (skin cancer) other than surgery or radiotherapy (interferon therapy may be acceptable and can be reviewed during screening)
• HIV, active Hepatitis B or C, organ or bone marrow transplant
• Active autoimmune disease (except diabetes and/or vitiligo)

Key Criteria List

Inclusion Criteria:

• Melanoma (skin cancer) that has spread to another area(s) (e.g. lymph node) and is at high risk of coming back
• Surgery to remove the skin cancer within 13 weeks before study enrollment
• Cancer free at study entry (after surgery)
• Willing to provide a sample of the skin cancer tumor to create the vaccine
• Normal organ and bone marrow function

Exclusion Criteria:

• Prior cancer, unless no evidence of that cancer for at least 5 years prior to study entry
• Prior medical treatment for your skin cancer (except surgery and interferon for thick primary melamonas. Radiotherapy after lymph node dissection is permitted)
• Active autoimmune disease (except diabetes and/or vitiligo)
• Immunodeficiency, systemic steroid therapy or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
• Solid organ or allogeneic bone marrow transplant
• Pneumonitis or a history of (noninfectious) pneumonitis that required steroids
• Prior interstitial lung disease
• Clinically significant heart failure
• Known history of HIV
• Known active hepatitis B or C
• Active infection requiring treatment

What to Expect

If you agree to participate in the study, you will have a screening visit at the study site. At this visit, the study doctor will review your medical history, conduct a physical examination, draw blood and collect a urine sample to confirm if you are eligible to participate. The study doctor will also use a sample of your tumor that was removed in your surgery to see if it can be utilized to make your personalized vaccine.

During participation, you will need to regularly travel to the study site for up to 3 years. You will have site visits every 3 weeks (21 days) for up to 1 year (approximately 18 visits) to receive study treatment and check your health. After you complete study treatment, you will be asked to complete safety follow-up visits. If your disease has not come back, you will be asked to come in for scans (every 3 to 6 months) for up to 2 years.

You will need to travel to one of the 17 sites taking part in this clinical trial. Sites are located in:

Why Participate

All patients in this study will receive pembrolizumab (also called Ketruda) and have regular health check-ups with the study doctor at no cost to you.

Pembrolizumab helps your immune system to fight cancer. Pembrolizumab is approved by the FDA for the treatment of patients with certain types of cancer including the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Some patients on this study will take just pembrolizumab, and some patients will take the combination of both pembrolizumab and mRNA-4157. Giving pembrolizumab and mRNA-4157 together may help the immune system to kill more cancer cells, but it is not known if the combination of pembrolizumab and mRNA-4157 will work any better.

It is possible that you may not personally benefit from your participation in this study. However, by taking part, you will provide new information that may benefit other patients in the future.

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