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for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:



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


Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma Carcinoma Carcinoma, Renal Cell Nivolumab Everolimus Sirolimus Antibodies, Monoclonal


For people ages 18 years and up

For more information regarding BMS clinical trial participation, please visit

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


  • Ucsf Helen Diller Family Comprehensive Cancer Center
    San Francisco, California, 94115, United States
  • Stanford Cancer Institute
    Stanford, California, 94305, United States
  • Cedars Sinai Medical Center
    Los Angeles, California, 90048, United States
  • University Of Southern California
    Los Angeles, California, 90033, United States


in progress, not accepting new patients
Start Date
Completion Date
Bristol-Myers Squibb
BMS Clinical Trial Information
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Phase 3
Study Type
Last Updated
January 18, 2018