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This trial is not actively recruiting.
This trial has completed recruitment on this platform, and is no longer accepting new referrals.
A clinical trial for patients with skin cancer.
An Efficacy Study of Adjuvant Treatment with a Personalized mRNA Cancer Vaccine and Pembrolizumab in Melanoma Patients at High Risk of Cancer Recurrence
Every patient’s cancer is unique. At Moderna, we believe mRNA personalized vaccines may bring us much closer to the goal of helping cure more patients of their cancers
— Tal Zaks, MD
Moderna is creating individualized, mRNA-based personalized cancer vaccines (PCVs) to deliver a custom-tailored medicine for one patient at a time.
This study is for people with high risk melanoma (skin cancer), who have had surgery for their skin cancer and are currently disease-free, but who have a high risk of it coming back.
The purpose of the study is to test whether the combination of the approved immunotherapy, pembrolizumab (also called Keytruda), and the mRNA-4157 personalized cancer vaccine works better than just pembrolizumab to prevent the skin cancer from coming back.
Be 18 years or older
Have had surgery to remove melanoma (skin cancer) within the past 13 weeks
Have a high risk of their skin cancer coming back (to be assessed during the screening process)
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)
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:
New Haven, Connecticut, United States
Hackensack, New Jersey, United States
(Awaiting confirmation) Santa Monica, California, United States
(Awaiting confirmation) Portland, Oregon, United States
(Awaiting confirmation) Nashville, Tennessee, United States
(Awaiting confirmation) Boston, Massachusetts, United States
(Awaiting confirmation) Subiaco, Western Australia, AU
(Awaiting confirmation) Westmead, New South Wales, AU
(Awaiting confirmation) West Palm Beach, Florida, United States
(Awaiting confirmation) Washington, District of Columbia, United States
(Awaiting confirmation) Dallas, Texas, United States
(Awaiting confirmation) Woolloongabba, Queensland, AU
(Awaiting confirmation) New York, New York, United States
(Awaiting confirmation) Saint Louis, Missouri, United States
(Awaiting confirmation) Aurora, Colorado, United States
(Awaiting confirmation) San Francisco, California, United States
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.