A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

• Status: Recruiting
• Trial end date: 2030-08-16
• Target enrollment: 0
• Participant gender: All

Summary

A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: BCG Vaccine; Nivolumab

Criteria

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

Inclusion:

• Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma

• Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as BCG unresponsive

• Histologically confirmed persistent or recurrent high-risk non-muscle-invasive urothelial carcinoma (UC)

• Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses)

• Sufficient tissue for both biomarker analysis and central pathology review committee (PRC) confirmation of diagnosis

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

• Women of child bearing potential (WOCBP) and men with WOCBP partners must agree to follow contraceptive requirements

Exclusion Criteria

• Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic UC

• UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment

• UC and/or CIS in the prostatic urethra within 12 months of enrollment

• Prior surgery (other than transurethral resection of the bladder tumor (TURBT)/biopsies) for bladder cancer; prior radiation therapy, or systemic chemotherapy or immunotherapy for bladder cancer or UC

Other inclusion/exclusion criteria apply.