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

Key Inclusion 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

Key Exclusion Criteria:

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