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

Purpose

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

Eligibility


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

Intervention(s):

drug: Everolimus

biological: Nivolumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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