Clinical trial of MK-7648A in adults and children with skin cancer

Prior treatment

• Has known concurrent active Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) and Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infection
• Has had an allogenic tissue/solid organ transplant
• Has 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 medication
• Has not adequately recovered from major surgical procedure or has ongoing surgical complications
• Has received prior radiotherapy within 2 weeks of start of study intervention or has had a history of radiation pneumonitis
• Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
• Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration

Other illness

• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has an active infection requiring systemic therapy
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has a history of central nervous system (CNS) metastases and/or carcinomatous meningitis

Other

• Has ocular, mucosal, or conjunctival melanoma

• 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 guidelines
• Has not received any prior systemic therapy for melanoma beyond surgical resection
• Has had no more than 12 weeks between final surgical resection and randomization
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)