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)

Part 2: Worsening-Free Survival

The time from randomization to progression to muscle-invasive disease (ie, T2), cystectomy, systemic chemotherapy, radiotherapy, or death from any cause. Data Not Collected (DNC)

Time frame: Approximately 44 months and 1 week

Part 2: Overall Survival

The time between the date of randomization and the date of death due to any cause. For participants still alive, OS is censored at the last date the participant is known to be alive. Data Not Collected (DNC)

Time frame: Approximately 44 months and 1 week

Part 2: Complete Response Rate at 13 Weeks

CRR is defined as the proportion of participants with CIS (+/- TaHG/T1) per PRC at randomization who are disease free at the first disease assessment (Week 13) Data Not Collected (DNC)

Time frame: 13 Weeks

Part 2: Duration of Response

the time between the date of the first CR to the date of first documented recurrence, progression, or death due to any cause. Data Not Collected (DNC)

Time frame: Approximately 44 months and 1 week

All-causality Adverse Events Leading to Discontinuation

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be based on NCI CTCAE version 5.0 criteria.