A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy

Inclusion Criteria: * Histologically confirmed squamous cell carcinoma of the penis * Measurable disease per Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) * Unresectable/metastatic disease that is unfit for platinum-based chemotherapy OR disease that has progressed on or after treatment with platinum-based chemotherapy * ≥18 years of age * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 Exclusion Criteria: * Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways * Major surgery ≤4 weeks or major radiation therapy ≤2 weeks prior to enrollment * Known symptomatic central nervous system (CNS) metastases requiring steroids * Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent * Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy