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

Trial ID or NCT#

NCT01668784

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
    1. Other protocol-defined inclusion/exclusion criteria apply
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Investigator(s)

Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

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Contact

CCTO
650-498-7061

View on ClinicalTrials.gov