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)

NCT ID: NCT04149574

Last Updated: 2025-09-16

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2023-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Urinary Bladder Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)

Group Type EXPERIMENTAL

nivolumab

Intervention Type DRUG

Specified Dose on Specified Days

Bacillus Calmette-Guérin (BCG)

Intervention Type BIOLOGICAL

Specified Dose on Specified Days

Arm B: placebo +BCG

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Specified Dose on Specified Days

Bacillus Calmette-Guérin (BCG)

Intervention Type BIOLOGICAL

Specified Dose on Specified Days

Interventions

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nivolumab

Specified Dose on Specified Days

Intervention Type DRUG

Placebo

Specified Dose on Specified Days

Intervention Type OTHER

Bacillus Calmette-Guérin (BCG)

Specified Dose on Specified Days

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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The University Of Chicago

Chicago, Illinois, United States

Site Status

Local Institution - 0084

The Bronx, New York, United States

Site Status

Local Institution - 0009

Caba, Buenos Aires, Argentina

Site Status

Local Institution - 0088

Capital Federal, Buenos Aires, Argentina

Site Status

Local Institution - 0016

Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina

Site Status

Local Institution - 0081

Mar del Plata, Buenos Aires, Argentina

Site Status

Local Institution - 0008

Viedma, Río Negro Province, Argentina

Site Status

Local Institution - 0080

Buenos Aires, , Argentina

Site Status

Local Institution - 0107

Córdoba, , Argentina

Site Status

Local Institution - 0002

Sydney, New South Wales, Australia

Site Status

Local Institution - 0001

Woolloongabba, Queensland, Australia

Site Status

Local Institution - 0114

Bowral, , Australia

Site Status

Local Institution - 0097

Linz, , Austria

Site Status

Local Institution - 0104

Salzburger, , Austria

Site Status

Local Institution - 0099

Vienna, , Austria

Site Status

Local Institution - 0098

Wels, , Austria

Site Status

Local Institution - 0050

Uberlândia, Minas Gerais, Brazil

Site Status

Local Institution - 0048

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Local Institution - 0047

Itajaí, Santa Catarina, Brazil

Site Status

Local Institution - 0049

Rio de Janeiro, , Brazil

Site Status

Local Institution - 0017

Toronto, Ontario, Canada

Site Status

Local Institution - 0038

Montreal, Quebec, Canada

Site Status

Local Institution - 0037

Montreal, Quebec, Canada

Site Status

Local Institution - 0012

Rimouski, Quebec, Canada

Site Status

Local Institution - 0011

La Serena, Coquimbo Region, Chile

Site Status

Local Institution - 0072

Viña del Mar, Región de Valparaíso, Chile

Site Status

Local Institution - 0010

Recoleta, Santiago Metropolitan, Chile

Site Status

Local Institution - 0042

Angers, , France

Site Status

Local Institution - 0106

Dijon, , France

Site Status

Local Institution - 0045

Lille, , France

Site Status

Local Institution - 0108

Marseille, , France

Site Status

Local Institution - 0111

Paris, , France

Site Status

Local Institution - 0103

Paris, , France

Site Status

Local Institution - 0041

Strasbourg, , France

Site Status

Local Institution - 0040

Villejuif, , France

Site Status

Local Institution - 0105

Cologne, , Germany

Site Status

Local Institution - 0094

Herne, , Germany

Site Status

Local Institution - 0093

Jena, , Germany

Site Status

Local Institution - 0095

Trier, , Germany

Site Status

Local Institution - 0031

Haidari, , Greece

Site Status

Local Institution - 0032

Thessaloniki, , Greece

Site Status

Local Institution - 0075

Tel Aviv, Tel Aviv, Israel

Site Status

Local Institution - 0073

Jerusalem, , Israel

Site Status

Local Institution - 0074

Ramat Gan, , Israel

Site Status

Local Institution - 0067

Torino, TO, Italy

Site Status

Local Institution - 0062

Milan, , Italy

Site Status

Local Institution - 0063

Modena, , Italy

Site Status

Local Institution - 0064

Napoli, , Italy

Site Status

Local Institution - 0065

Reggio Emilia, , Italy

Site Status

Local Institution - 0066

Roma, , Italy

Site Status

Local Institution - 0054

Arnhem, , Netherlands

Site Status

Local Institution

Rotterdam, , Netherlands

Site Status

Local Institution - 0051

Moscow, , Russia

Site Status

Local Institution - 0052

Saint Petersburg, , Russia

Site Status

Local Institution - 0096

Pamplona, Navarre, Spain

Site Status

Local Institution - 0061

Badajoz, , Spain

Site Status

Local Institution - 0060

Badalona-barcelona, , Spain

Site Status

Local Institution - 0055

Madrid, , Spain

Site Status

Local Institution - 0059

Sabadell, , Spain

Site Status

Local Institution - 0057

Santander, , Spain

Site Status

Local Institution - 0058

Valencia, , Spain

Site Status

Local Institution - 0087

Norrköping, , Sweden

Site Status

Local Institution - 0083

Umeå, , Sweden

Site Status

Countries

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United States Argentina Australia Austria Brazil Canada Chile France Germany Greece Israel Italy Netherlands Russia Spain Sweden

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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CA209-7G8

Identifier Type: -

Identifier Source: org_study_id

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