Study on Nivolumab and Ipilimumab with or without Radiation for Treating Metastatic Merkel Cell Carcinoma

Inclusion Criteria

• Must be 18 years or older.
• Must have a performance status that allows for daily activities with some restrictions.
• Must have active cancer that can be measured by scans or physical exams.
• Previous chemotherapy or immunotherapy is allowed if there are new or ongoing cancer sites.
• Previous radiation therapy is allowed if there is active cancer that can be measured.
• Cancer must be recurrent, cannot be removed by surgery, or be at Stage IV, and must be confirmed as Merkel cell carcinoma with at least two separate cancer sites.
• Must have at least two separate cancer sites confirmed by physical exam or imaging within four weeks before starting the study. Imaging must include a CT scan of the cancer sites and a brain MRI or CT if MRI is not possible.
• Must provide a tumor sample for analysis.

Exclusion Criteria

• History of severe side effects or use of infliximab with previous immunotherapy.
• Active cancer spread to the brain.
• Active or suspected autoimmune diseases, except for type I diabetes, thyroid issues needing hormone replacement, or skin conditions like vitiligo or psoriasis that don't need systemic treatment.
• History of other cancers, except for certain skin cancers, chronic lymphocytic leukemia, or other slow-growing diseases not needing treatment, or cancers treated with the intent to cure and currently in remission, or breast cancer with no disease on hormone therapy, or prostate cancer on hormone therapy with undetectable PSA levels.
• Need for systemic treatment with steroids or other immune-suppressing drugs within 14 days before starting the study, except for inhaled or topical steroids if there is no active autoimmune disease.