Brief Title: Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Urinary Bladder Neoplasms

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION