A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder
NCT ID: NCT03519256
Last Updated: 2023-06-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
142 participants
INTERVENTIONAL
2018-08-02
2022-08-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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)
NCT04149574
Bladder PREserVation by RadioTherapy and Immunotherapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer
NCT03950362
Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer
NCT03892642
Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)]
NCT03504163
A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
NCT03661320
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nivolumab monotherapy
Nivolumab
Specified dose on specified days
Nivolumab + BCG
Nivolumab
Specified dose on specified days
BCG
Specified dose on specified days
Nivolumab + BMS-986205
Nivolumab
Specified dose on specified days
BMS-986205
Specified dose on specified days
Nivolumab + BMS-986205 + BCG
Nivolumab
Specified dose on specified days
BCG
Specified dose on specified days
BMS-986205
Specified dose on specified days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nivolumab
Specified dose on specified days
BCG
Specified dose on specified days
BMS-986205
Specified dose on specified days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants must have CIS to be eligible.
* Predominant histologic component (\> 50%) must be urothelial (transitional cell) carcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria
* Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
* Prior immuno-oncology therapy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution - 0044
Los Angeles, California, United States
Local Institution - 0081
Riverside, California, United States
Local Institution - 0087
San Francisco, California, United States
Local Institution - 0125
Tampa, Florida, United States
Local Institution - 0056
Hapeville, Georgia, United States
Local Institution - 0023
New Lenox, Illinois, United States
Wichita Urology Group
Wichita, Kansas, United States
Local Institution - 0001
Baltimore, Maryland, United States
Local Institution - 0077
Ann Arbor, Michigan, United States
Local Institution - 0032
Minneapolis, Minnesota, United States
Local Institution - 0040
Omaha, Nebraska, United States
Local Institution - 0144
New Brunswick, New Jersey, United States
Deleware Valley Urology, LLC
Voorhees Township, New Jersey, United States
Local Institution - 0051
New York, New York, United States
Local Institution - 0058
Columbus, Ohio, United States
Local Institution - 0036
Bala-Cynwyd, Pennsylvania, United States
Local Institution - 0049
Charleston, South Carolina, United States
Local Institution - 0002
Myrtle Beach, South Carolina, United States
Local Institution - 0057
Chattanooga, Tennessee, United States
Urology Clinics Of North Texas, Pa
Dallas, Texas, United States
Local Institution - 0048
Houston, Texas, United States
Local Institution - 0140
Houston, Texas, United States
Local Institution - 0047
Lubbock, Texas, United States
Urology San Antonio Research, Pa
San Antonio, Texas, United States
Local Institution - 0141
Seattle, Washington, United States
Local Institution - 0068
Capital Federal, Buenos Aires, Argentina
Local Institution - 0065
Capital Federal, Distrito Federal, Argentina
Local Institution - 0089
Ciudad Autonoma Buenos Aires, Distrito Federal, Argentina
Local Institution
Viedma, Río Negro Province, Argentina
Instituto Oncologico De Cordoba
Córdoba, , Argentina
Local Institution - 0137
Mendoza, , Argentina
Local Institution - 0146
Camperdown, New South Wales, Australia
Local Institution - 0148
St Leonards, New South Wales, Australia
Local Institution - 0072
Fortaleza, Ceará, Brazil
Local Institution - 0151
Curitiba, Paraná, Brazil
Local Institution - 0073
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Itacorubi, Florianopolis, Santa Catarina, Brazil
Local Institution - 0078
Jaú, São Paulo, Brazil
Local Institution - 0150
Rio de Janeiro, , Brazil
Local Institution - 0074
São Paulo, , Brazil
Local Institution - 0143
North York, Ontario, Canada
Local Institution - 0086
Toronto, Ontario, Canada
Local Institution - 0084
Toronto, Ontario, Canada
Local Institution - 0046
Québec, Quebec, Canada
Local Institution - 0154
Santiago, Santiago Metropolitan, Chile
Local Institution - 0069
Santiago, Santiago Metropolitan, Chile
Local Institution - 0128
Beijing, Beijing Municipality, China
Local Institution - 0131
Beijing, Beijing Municipality, China
Local Institution - 0116
Beijing, Beijing Municipality, China
Local Institution - 0099
Beijing, Beijing Municipality, China
Local Institution - 0129
Chongqing, Chongqing Municipality, China
Local Institution - 0108
Fuzhou, Fujian, China
Local Institution - 0117
Guangzhou, Guangdong, China
Local Institution - 0102
Nanjing, Jiangsu, China
Local Institution - 0109
Nanchang, Jiangxi, China
Local Institution - 0112
Jinan, Shandong, China
Local Institution - 0111
Yantai, Shandong, China
Local Institution - 0098
Shanghai, Shanghai Municipality, China
Local Institution - 0094
Shanghai, Shanghai Municipality, China
Local Institution - 0097
Shanghai, Shanghai Municipality, China
Local Institution - 0120
Chengdu, Sichuan, China
Local Institution - 0133
Tianjin, Tianjin Municipality, China
Local Institution - 0126
Hangzhou, Zhejiang, China
Local Institution - 0027
Suresnes, Hauts-de-Seine, France
Local Institution - 0028
Angers, Maine-et-Loire, France
Local Institution - 0031
Bordeaux, , France
Local Institution - 0088
Lille, , France
Local Institution - 0091
Strasbourg, , France
Local Institution - 0093
Hong Kong, , Hong Kong
IRCCS Istituto Nazionale Tumori Milano
Milan, , Italy
Instituto Nazionale Tumori Fondazione G. Pascale
Napoli, , Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Local Institution - 0062
Tuxtla Gutiérrez, Chiapas, Mexico
Local Institution - 0055
Mexico City, Mexico City, Mexico
Local Institution - 0004
Amsterdam, , Netherlands
Local Institution - 0003
Nijmegen, , Netherlands
Local Institution - 0005
Utrecht, , Netherlands
Local Institution - 0070
Omsk, , Russia
Local Institution - 0054
Saint Petersburg, , Russia
Local Institution - 0153
Saint Petersburg, , Russia
Local Institution
Madrid, , Spain
Local Institution - 0033
Málaga, , Spain
Local Institution - 0139
Santander, , Spain
Local Institution - 0136
Valencia, , Spain
Local Institution
Chelmsford, Essex, United Kingdom
Local Institution
London, Greater London, United Kingdom
Local Institution - 0013
Southampton, Hampshire, United Kingdom
Local Institution - 0015
Lancaster, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-003581-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-9UT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.