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

• Status: Active, not recruiting
• Trial end date: 2024-09-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Linrodostat; Nivolumab

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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 could apply