Study on Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab for High-Risk Melanoma

Inclusion Criteria

• Have melanoma that has spread to a lymph node and can be surgically removed, with a high risk of coming back.
• Have had surgery to completely remove the melanoma within 13 weeks before starting pembrolizumab treatment.
• Be free of cancer at the start of the study, with no signs of cancer returning or spreading to other parts of the body, including the brain.
• Have a tumor sample available for genetic testing.
• Be in good overall health, with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have normal organ and bone marrow function as shown by blood tests at screening.

Exclusion Criteria

• Have had another type of cancer in the past, unless it has been gone for at least 5 years before joining the study.
• Have received any previous anti-cancer treatments, except for surgery and interferon for thick melanomas. Radiation after lymph node surgery is allowed.
• Have received a live vaccine within 30 days before starting pembrolizumab.
• Have had a blood transfusion or received medications to boost blood cell production within 2 weeks before the screening blood test.
• Have an active autoimmune disease.
• Have an immune deficiency or are taking steroids or other medications that suppress the immune system within 7 days before starting pembrolizumab.
• Have had a solid organ or bone marrow transplant.
• Have or have had lung inflammation (pneumonitis) that required steroid treatment.
• Have had interstitial lung disease.
• Have significant heart failure.
• Have a known history of HIV.
• Have active hepatitis B or C.
• Have an active infection that requires treatment.