An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma

Inclusion Criteria:

Advanced or Metastatic renal cell carcinoma (RCC)

Predominant clear cell histology:

At least 1 but no more than 2 prior systemic anti vascular endothelial growth factor (anti-VEGF) treatments
No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting
Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are eligible
Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor
Brain metastases allowed if asymptomatic, without edema, and not receiving corticosteroids or radiation
Performance Status (PS): ≥ 70% Karnofsky Performance Scale (KPS)
All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed

Exclusion Criteria:

Subjects with any active autoimmune disease or a history of known autoimmune disease
History of severe hypersensitivity reaction to other monoclonal antibodies
Prior malignancy, active within the last 3 years, except for locally curable cancers which have been apparently cured
Known HIV or AIDS-related illness
Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic infection

Other protocol-defined inclusion/exclusion criteria apply