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

A Phase 3b/4 Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Renal Cell Carcinoma (CheckMate 374: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 374)

This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab.

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

Other protocol-defined inclusion/exclusion criteria apply