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

Completed · Phase 3

Conditions studied: Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma

In brief

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

Key facts

Study ID

NCT01668784

Run by

Bristol-Myers Squibb

People needed

821

Starts

2012-10-09

Expected to finish

2021-07-19

Last updated by the study team

2022-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• UCSD Moores Cancer Center — La Jolla, California, United States
• Local Institution - 0024 — Los Angeles, California, United States
• University Of Southern California — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Ucsf Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Stanford Cancer Institute — Stanford, California, United States
• University Of Colorado — Aurora, Colorado, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Local Institution - 0027 — Washington D.C., District of Columbia, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Winship Cancer Institute. — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Loyola University Chicago — Maywood, Illinois, United States
• Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
• University Of Iowa Hospitals And Clinics — Iowa City, Iowa, United States
• Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University Of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Memorial Sloan Kettering Nassau — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Local Institution - 0182 — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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