Summary

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

Description

Summary

The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response relationship exists.

Official Title

A Randomized, Blinded, Phase 2 Dose-Ranging Study Of BMS-936558 (MDX-1106) In Subjects With Progressive, Advanced/Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

Keywords

Renal Cell Carcinoma Advanced/Metastatic clear cell component 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:

  • Histologic confirmation of Renal cell carcinoma (RCC) with a clear cell component
  • Previous treatment with at least one anti-angiogenic agent
  • Progressed within 6 months of study enrollment
  • Subjects should not have had more than 3 prior treatments for locally advanced or metastatic disease
  • Must have available tumor tissue for submission
  • Subjects must also meet various laboratory parameters for inclusion

Exclusion Criteria:

  • Subjects with any active autoimmune disease or a history of known autoimmune disease

Locations

  • UCSD Moores Cancer Center
    La Jolla California 92093 United States
  • Samuel Oschin Comprehensive Cancer Inst.
    Los Angeles California 90048 United States
  • Ucla
    Los Angeles California 90024 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
NCT01354431
Phase
Phase 2
Study Type
Interventional
Last Updated
January 24, 2018