A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer


Condition: Bladder Cancer, Bladder Tumors, Neoplasms, Bladder

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03519256

Sponsor: Bristol-Myers Squibb

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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 Other protocol defined inclusion/

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 Other protocol defined inclusion/exclusion criteria could apply

View trial on ClinicalTrials.gov