A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

Study Status

Open to Enrollment

Study Description

This clinical trial is evaluating the effectiveness of an experimental drug called BMS-936558 in treating advanced or metastatic renal cell carcinoma (cancer that begins in the kidneys), compared to the approved drug Everolimus.

BMS-936558 is an antibody (a type of human protein) against PD-1, a protein involved in repressing the immune system. Blocking PD-1 with an antibody activates the immune system and enables it to fight tumors. BMS-936558 is administered via infusion.

Everolimus is an oral pill. It is FDA-approved to treat advanced kidney cancer.

Study participants will be randomly assigned to receive either:

  • Arm A: BMS-936558 via infusion every 2 weeks
  • Arm B: Everolimus pill taken by mouth daily

Participants may continue with study treatment as long as they are responding to therapy and not experiencing intolerable side effects. 

Disease Status and/or Stage

Advanced or Metastatic Kidney Cancer


Bristol-Myers Squibb

Key Eligibility

  • Men and women age 18 and older
  • Advanced or metastatic renal cell carcinoma
  • Must have received one or two prior anti-angiogenic therapy regimens (including but but not limited to sunitinib, sorafenib, pazopanib, axitinib, tivozanib, and bevacizumab) for treating advanced or metastatic disease
  • No more than 3 total prior systemic treatment regimens for advanced or metastatic disease, and must have progressed after the last treatment regimen and within 6 months of enrolling in the study
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Himisha Beltran, M.D.


Protocol ID

BMS CA209-025-041

Healthy Volunteers


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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