Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)
Trial ID or NCT#
The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy
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
- - 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%
- - 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
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