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A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder

Trial Status: Active

A study to evaluate Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer

Inclusion Criteria

  • Pathologically demonstrated BCG-unresponsive, carcinoma in situ (CIS)-containing high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without papillary component
  • Participants must have CIS to be eligible.
  • Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria

  • Sign of locally advanced disease or metastatic bladder cancer
  • Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
  • Prior immuno-oncology therapy

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Roberto Tejada
Phone: 323-865-0461
San Francisco
UCSF Medical Center-Mount Zion
Status: APPROVED
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: APPROVED

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

South Carolina

Charleston
Medical University of South Carolina
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Texas

Houston
M D Anderson Cancer Center
Status: COMPLETED

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: IN_REVIEW

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

  • Primary ID CA209-9UT
  • Secondary IDs NCI-2018-01177, 2017-003581-27
  • Clinicaltrials.gov ID NCT03519256