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) (CheckMate 7G8)

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 3

Conditions: Urinary Bladder Neoplasms

Treatments: Other: Placebo; Biological: Bacillus Calmette-Guérin (BCG); Drug: nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04149574

CA209-7G8

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups, including a placebo group

Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)

Experimental group

Treatment:

Drug: nivolumab

Biological: Bacillus Calmette-Guérin (BCG)

Arm B: placebo +BCG

Placebo Comparator group

Treatment:

Biological: Bacillus Calmette-Guérin (BCG)

Other: Placebo