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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Subjects with histological confirmation of RCC
Advanced or metastatic disease
Measurable disease as defined by RECIST 1.1 criteria
Karnofsky Performance Status (KPS) ≥80%
Available tumor tissue (archival or recent acquisition)

Subjects enrolled in the I-1, I-3 expansion arms and IN-3 addition arms must not have received any prior systemic therapy for RCC with the following exceptions:

One prior adjuvant or neoadjuvant therapy for localized or locally advanced RCC is allowed provided recurrence occurred ≥ 6 months after the last dose of the adjuvant or neoadjuvant therapy
Only prior cytokine based treatment for metastatic RCC [eg, interferon-alpha (IFN-alpha) or interleukin 2 (IL-2)] as prior therapy is allowed

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 Serum creatinine >1.5x ULN or creatinine clearance <40 mL/min (Cockroft-Gault formula)

Exclusion Criteria for Arm S and Arm P only:

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