Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)

Not Recruiting

Trial ID: NCT01668784


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

Official Title

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

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


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

   - Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic

   - 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


drug: Everolimus

biological: Nivolumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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