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Participants must be 18 years or older and have a histological confirmation of RCC with a clear cell component.
Patients must also have the following: Advanced or metastatic RCC;
measurable disease as defined by RECIST 1.1 criteria;
must have received one or two prior anti-angiogenic therapy regimens (including, but not limited to, sunitinib, sorafenib, pazopanib, axitinib, tivozanib, and bevacizumab) in the advanced or metastatic setting (prior cytokine therapy (eg, IL-2, IFN-a), vaccine therapy, or treatment with cytotoxics is also allowed);
must have received no more than three total prior systemic treatment regimens in the advanced or metastatic setting, and must have evidence of progression on or after the last treatment regimen received and within six months prior to study enrollment;
Karnofsky Performance Score (KPS) = 70%;
tumor tissue (FFPE archival or recent acquisition) must be received by the central vendor (block or unstained slides) for correlative studies in order to randomize a subject to study treatment.
The purpose of this study is to compare the effectiveness (how well the drug works), safety and tolerability of an investigational drug, BMS-936558 against the approved drug, Everolimus, in subjects with advanced or metastatic renal cell carcinoma. BMS-936558 is an antibody (a type of human protein) that is being tested to see if it will allow the bodys immune system to work against tumor cells. An investigational drug is one that is not approved by the FDA or any other agency and is being studied and developed.