A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)

The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.

Inclusion Criteria:Has surgically resected and histologically or pathologically confirmed diagnosis of Stage IIB and IIC (pathological or clinical), III, or IV cutaneous melanoma per the American Joint Committee on Cancer (AJCC) eighth edition guidelinesHas not received any prior systemic therapy for melanoma beyond surgical resectionHas had no more than 12 weeks between final surgical resection and randomizationHuman immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomizationParticipants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screeningExclusion Criteria:Has ocular, mucosal, or conjunctival melanomaHas a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medicationHas not adequately recovered from major surgical procedure or has ongoing surgical complicationsHas received prior radiotherapy within 2 weeks of start of study intervention or has had a history of radiation pneumonitisReceived a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowedHas received an investigational agent or has used an investigational device within 4 weeks before study intervention administrationHas a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung diseaseHas a known additional malignancy that is progressing or has required active treatment within the past 3 yearsHas known active central nervous system (CNS) metastases and/or carcinomatous meningitisHas an active autoimmune disease that has required systemic treatment in past 2 yearsHas an active infection requiring systemic therapyHas had an allogenic tissue/solid organ transplant