Phase 3 Study of Pembrolizumab plus Enzalutamide in mCRPC

Prior treatment

• Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
• Known active human immunodeficiency virus (HIV), concurrent active hepatitis B virus (HBV) or known active hepatitis C virus (HCV) infection
• Received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer

Other illness

• Known additional malignancy that is progressing or has required active treatment in the last 3 years
• Active autoimmune disease that has required systemic treatment in past 2 years
• Gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
• History of seizure or any condition that may predispose to seizure

• Histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
• Prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization
• Current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
• Ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)