Summary

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

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 BMS-936558 (Anti-PD-1)

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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
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