An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)

Eligibility Criteria

• * Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence
• * Complete resection within 13 weeks prior to the first dose of pembrolizumab
• * Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases
• * Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing
• * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• * Normal organ and marrow function reported at screening
• * Prior malignancy, unless no evidence of that disease for at least 5 years prior to study entry
• * Prior systemic anti-cancer treatment (except surgery and interferon for thick primary melanomas. Radiotherapy after lymph node dissection is permitted)
• * Live vaccine within 30 days prior to the first dose of pembrolizumab
• * Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample
• * Active autoimmune disease
• * 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 human immunodeficiency virus (HIV)
• * Known active hepatitis B or C
• * Active infection requiring treatment