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
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View full resultsBasic Information
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TERMINATED
PHASE3
13 participants
INTERVENTIONAL
2020-01-15
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)
nivolumab
Specified Dose on Specified Days
Bacillus Calmette-Guérin (BCG)
Specified Dose on Specified Days
Arm B: placebo +BCG
Placebo
Specified Dose on Specified Days
Bacillus Calmette-Guérin (BCG)
Specified Dose on Specified Days
Interventions
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nivolumab
Specified Dose on Specified Days
Placebo
Specified Dose on Specified Days
Bacillus Calmette-Guérin (BCG)
Specified Dose on Specified Days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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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
Local Institution - 0084
The Bronx, New York, United States
Local Institution - 0009
Caba, Buenos Aires, Argentina
Local Institution - 0088
Capital Federal, Buenos Aires, Argentina
Local Institution - 0016
Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
Local Institution - 0081
Mar del Plata, Buenos Aires, Argentina
Local Institution - 0008
Viedma, Río Negro Province, Argentina
Local Institution - 0080
Buenos Aires, , Argentina
Local Institution - 0107
Córdoba, , Argentina
Local Institution - 0002
Sydney, New South Wales, Australia
Local Institution - 0001
Woolloongabba, Queensland, Australia
Local Institution - 0114
Bowral, , Australia
Local Institution - 0097
Linz, , Austria
Local Institution - 0104
Salzburger, , Austria
Local Institution - 0099
Vienna, , Austria
Local Institution - 0098
Wels, , Austria
Local Institution - 0050
Uberlândia, Minas Gerais, Brazil
Local Institution - 0048
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0047
Itajaí, Santa Catarina, Brazil
Local Institution - 0049
Rio de Janeiro, , Brazil
Local Institution - 0017
Toronto, Ontario, Canada
Local Institution - 0038
Montreal, Quebec, Canada
Local Institution - 0037
Montreal, Quebec, Canada
Local Institution - 0012
Rimouski, Quebec, Canada
Local Institution - 0011
La Serena, Coquimbo Region, Chile
Local Institution - 0072
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0010
Recoleta, Santiago Metropolitan, Chile
Local Institution - 0042
Angers, , France
Local Institution - 0106
Dijon, , France
Local Institution - 0045
Lille, , France
Local Institution - 0108
Marseille, , France
Local Institution - 0111
Paris, , France
Local Institution - 0103
Paris, , France
Local Institution - 0041
Strasbourg, , France
Local Institution - 0040
Villejuif, , France
Local Institution - 0105
Cologne, , Germany
Local Institution - 0094
Herne, , Germany
Local Institution - 0093
Jena, , Germany
Local Institution - 0095
Trier, , Germany
Local Institution - 0031
Haidari, , Greece
Local Institution - 0032
Thessaloniki, , Greece
Local Institution - 0075
Tel Aviv, Tel Aviv, Israel
Local Institution - 0073
Jerusalem, , Israel
Local Institution - 0074
Ramat Gan, , Israel
Local Institution - 0067
Torino, TO, Italy
Local Institution - 0062
Milan, , Italy
Local Institution - 0063
Modena, , Italy
Local Institution - 0064
Napoli, , Italy
Local Institution - 0065
Reggio Emilia, , Italy
Local Institution - 0066
Roma, , Italy
Local Institution - 0054
Arnhem, , Netherlands
Local Institution
Rotterdam, , Netherlands
Local Institution - 0051
Moscow, , Russia
Local Institution - 0052
Saint Petersburg, , Russia
Local Institution - 0096
Pamplona, Navarre, Spain
Local Institution - 0061
Badajoz, , Spain
Local Institution - 0060
Badalona-barcelona, , Spain
Local Institution - 0055
Madrid, , Spain
Local Institution - 0059
Sabadell, , Spain
Local Institution - 0057
Santander, , Spain
Local Institution - 0058
Valencia, , Spain
Local Institution - 0087
Norrköping, , Sweden
Local Institution - 0083
Umeå, , Sweden
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
Other Identifiers
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CA209-7G8
Identifier Type: -
Identifier Source: org_study_id
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