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: Event Free Survival (EFS)

Primary Outcome 1 - Timeframe: approximately 3 years

CONDITION

• Bladder Cancer

ELIGIBILITY

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.

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: Bristol-Myers Squibb

Phone: please email:

Email: Clinical.Trials@bms.com

LOCATION