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

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