A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG

CA209-7G8

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.

2020-01-15

2023-10-31

2023-10-31

Terminated

Early phase I

13

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 13, 'type': 'ACTUAL'}}

2024-04-19