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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 this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.

Official Title

An Exploratory Study to Investigate the Immunomodulatory Activity of Various Dose Levels of Anti Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Subjects With Metastatic Clear Cell Renal Cell Carcinoma (RCC).


Intervention Model: Parallel Dose Comparison


Renal Cell Carcinoma Nivolumab Antibodies, Monoclonal


For people ages 18 years and up

For more information regarding BMS clinical trial participation, please visit

Inclusion Criteria:

  • Women and men ≥ 18 years of age.
  • Histologic confirmation of renal cell carcinoma with a clear cell component.
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors(RECIST).
  • Tumor sites that can be accessed for repeat biopsies at acceptable clinical risk.
  • Previously treated subjects must have failed at least 1 prior anti-angiogenic agent and can have a maximum of 3 prior systemic treatments for renal cell cancer.
  • Subjects in the treatment naive arm cannot have received prior systemic therapy for their renal cell carcinoma.

Exclusion Criteria:

  • Active or progressing brain metastases.
  • Active concomitant.
  • Active or history of autoimmune disease.
  • Active use of systemic corticosteroids.
  • Prior therapy with Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4), anti Programmed death-1 (anti-PD1), anti Programmed death ligand 1 (anti-PD-L1), anti Programmed death ligand 2 (anti-PD-L2), anti-CD137, anti-CD40, anti-OX40 antibodies.


  • Providence Portland Med Ctr
    Portland, Oregon, 97213, United States
  • University Of Wisconsin Carbone Cancer Center
    Madison, Wisconsin, 53705, United States
  • University Of Chicago Medical Center
    Chicago, Illinois, 60637, United States
  • Upmc Cancer Pavilion
    Pittsburgh, Pennsylvania, 15232, United States
  • H. Lee Moffitt Cancer Center
    Tampa, Florida, 33612, United States
  • Duke University Medical Center
    Durham, North Carolina, 27710, United States
  • The Bunting-Blaustein Cancer Research Building
    Baltimore, Maryland, 21231, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania, 19111, United States
  • Yale University School Of Medicine
    New Haven, Connecticut, 06520, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts, 02215, United States
  • Dana Farber Cancer Inst
    Boston, Massachusetts, 02215, United States
  • Local Institution
    Villejuif Cedex, 94805, France
  • Local Institution
    Pamplona, 31192, Spain


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 1
Lead Scientist
Lawrence Fong
Study Type
Last Updated
August 1, 2017