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Active, Not Recruiting

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025) - CA209-025

Updated: 7 August, 2020   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm 1: Nivolumab
Biological: Nivolumab
Active Comparator: Arm 2: Everolimus
Drug: Everolimus

Key Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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