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)

Brief Summary

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.

Brief Title

Categories

Kidney & Urinary Tract

Prostate Cancer

Cancer

Endocrine System Cancers

Gastrointestinal (GI) Cancers

Gynecologic Cancers

Lung & Chest Cancers

Completion Date

2023-10-31

Completion Date Type

Actual

Conditions

Urinary Bladder Neoplasms

Eligibility Criteria

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

Inclusion Criteria

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

inclusion/

Gender

All

Gender Based

false

Healthy Volunteers

No

Last Update Post Date

Tue, 09/16/2025 - 12:00

Last Update Post Date Type

Estimated

Last Update Submit Date

Mon, 08/25/2025 - 12:00

Minimum Age

18 Years

NCT Id

NCT04149574

Org Class

Industry

Org Full Name

Bristol-Myers Squibb

Org Study Id

CA209-7G8

Overall Status

Terminated

Phases

Phase 3

Primary Completion Date

Tue, 10/31/2023 - 12:00

Primary Completion Date Type

Actual

Official Title

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

Primary Outcomes

Outcome Description

The time between the date of randomization and the date of first documented event or death due to any cause, whichever occurs first. Events include recurrence of disease (TaHG, T1, or CIS) and progression of disease.

Data Not Collected (DNC)

Outcome Measure

Part 2: Event Free Survival

Outcome Time Frame

Approximately 44 Months and 1 Week

Secondary Outcomes

Outcome Description

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)

Outcome Time Frame

Approximately 44 months and 1 week

Outcome Measure

Part 2: Worsening-Free Survival

Outcome Description

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)

Outcome Time Frame

Approximately 44 months and 1 week

Outcome Measure

Part 2: Overall Survival

Outcome Description

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)

Outcome Time Frame

13 Weeks

Outcome Measure

Part 2: Complete Response Rate at 13 Weeks

Outcome Description

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)

Outcome Time Frame

Approximately 44 months and 1 week

Outcome Measure

Part 2: Duration of Response

Outcome Description

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.

Outcome Time Frame

24.6 months

Outcome Measure

All-causality Adverse Events Leading to Discontinuation

Outcome Description

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.

Outcome Time Frame

24.6 months

Outcome Measure

All-causality Adverse Events

Outcome Description

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.

Outcome Time Frame

24.6 months

Outcome Measure

Drug-related Adverse Events