Study Comparing Pembrolizumab and Placebo for Preventing Recurrence in High-Risk Head and Neck Cancer

Inclusion Criteria

• Must have confirmed head and neck cancer, including specific types like squamous cell carcinoma and HPV+ or EBV+ tumors, at certain stages.
• Completed treatment aimed at curing the cancer within the last 20 weeks.
• Have a high risk (40-50% or more) of cancer returning, fitting into specific categories based on cancer type, treatment history, and other factors.
• Must provide a tumor sample for testing.
• Be 18 years or older and able to give consent.
• Have a good performance status, with some allowances for those recovering from treatment.
• Show reasonable organ function based on lab tests.
• Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for 120 days after the last dose.
• Men must agree to use contraception during the study and for 120 days after the last dose.

Exclusion Criteria

• Currently participating in another study or have recently used an investigational drug or device.
• Have an immune deficiency or are on immunosuppressive therapy.
• Have a history of active tuberculosis.
• Allergic to pembrolizumab or its ingredients.
• Have had recent treatment with certain cancer therapies and not fully recovered from side effects.
• Have another progressing cancer that requires treatment, with some exceptions.
• Have active brain metastases or certain autoimmune diseases.
• Have a history of non-infectious lung inflammation.
• Have conditions or treatments that could interfere with the study.
• Have psychiatric or substance abuse issues that could affect participation.
• Are pregnant, breastfeeding, or planning to conceive during the study period.
• Have previously received certain immune therapies.
• Have HIV, active hepatitis B or C, or have received a live vaccine recently.