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

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

Inclusion Criteria:

- Advanced or Metastatic renal cell carcinoma (RCC)

- Predominant clear cell histology:

1. At least 1 but no more than 2 prior systemic anti vascular endothelial growth
factor (anti-VEGF) treatments

2. No more than 3 total prior systemic treatment regimens in the advanced or
metastatic setting

3. 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