Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016)

Exclusion Criteria

• •Active central nervous system (CNS) metastases
• •Active or history of autoimmune disease
• •Ongoing symptomatic cardiac dysrhythmias or uncontrolled atrial fibrillation
• •History of cerebrovascular accident including transient ischemic attack within the past 12 months
• •History of pulmonary embolism or deep vein thrombosis (DVT) within the past 6 months
• •Chronic systemic steroids (\>10 mg/day Prednisone equivalents) or any other immunosuppressive agents
• •White blood cell (WBC) \<2,000/mm3
• •Neutrophiles \<1,500/mm3
• •Platelets \<100,000/mm3
• •Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>3x upper limit of normal (ULN)
• •Total Bilirubin \>1.5x ULN (except subjects with Gilbert syndrome, total bilirubin \<3.0 mg/dL)
• •Cardiac ejection fraction \<LLN (lower limit of normal)
• •Serum creatinine \>1.5x ULN or creatinine clearance \<40 mL/min (Cockroft-Gault formula)
• •For dose escalation cohorts - subjects who received prior Sunitinib or Pazopanib and required permanent discontinuation due to toxicity or required dose reduction or delay during the first 12 weeks of therapy due to toxicity, or received both prior Sunitinib and Pazopanib
• •Poorly controlled hypertension
• •Active bleeding or bleeding susceptibility