KEYNOTE-942: This study is assessing whether receiving a personalised cancer vaccine plus immunotherapy after surgery is more effective compared to receiving immunotherapy alone in people who have had their melanoma completely removed and are at a high risk of recurrenceA Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma

Exclusion

• 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