A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

Study start date: October 9, 2012

Inclusion Criteria: Men & women ≥18 years of age Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component Advanced/metastatic RCC Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment Karnofsky Performance Score ≥70% Exclusion Criteria: Any Central Nervous System (CNS) metastases or history of CNS metastases Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor Any active known or suspected autoimmune disease Uncontrolled adrenal insufficiency Active chronic liver disease Prior malignancy active within past 3 years, except for locally curable cancers Other protocol-defined inclusion/exclusion criteria apply