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Summary

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

Description

Summary

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).

Details

Intervention Model: Parallel Dose Comparison

Keywords

Renal Cell Carcinoma Carcinoma Carcinoma, Renal Cell Nivolumab Antibodies, Monoclonal

Eligibility

For people ages 18 years and up

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

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.

Locations

  • Ucsf Helen Diller Family Comprehensive Cancer Center
    San Francisco, California, 94115, United States
  • 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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
ID
NCT01358721
Phase
Phase 1
Lead Scientist
Lawrence Fong
Study Type
Interventional
Last Updated
November 29, 2017