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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 (CheckMate 9UT)

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ClinicalTrials.gov Identifier: NCT03519256
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
A study to evaluate Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer

Condition or disease Intervention/treatment Phase
Bladder Cancer Bladder Tumors Neoplasms, Bladder Biological: Nivolumab Biological: BCG Drug: BMS-986205 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : January 23, 2022
Estimated Study Completion Date : June 3, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Nivolumab monotherapy Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558

Experimental: Nivolumab + BCG Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558

Biological: BCG
Specified dose on specified day
Other Name: Bacillus Calumette-Guerin

Experimental: Nivolumab + BMS-986205 Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558

Drug: BMS-986205
Specified dose on specified day

Experimental: Nivolumab + BMS-986205 + BCG Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558

Biological: BCG
Specified dose on specified day
Other Name: Bacillus Calumette-Guerin

Drug: BMS-986205
Specified dose on specified day




Primary Outcome Measures :
  1. Proportion of carcinoma in situ (CIS) participants with complete response (CR), per Pathology Review Committee (PRC) [ Time Frame: Up to 5 years ]
  2. Duration of complete response (DOCR), per PRC, in CIS participants with CR [ Time Frame: Up to 5 years ]
  3. Event Free Survival (EFS), per PRC, for all non-CIS participants [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]
  2. Incidence of Adverse Events (AEs) [ Time Frame: Up to 15 months ]
  3. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 15 months ]
  4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 15 months ]
  5. Incidence of deaths [ Time Frame: Up to 5 years ]
  6. Incidence of laboratory abnormalities [ Time Frame: Up to 15 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Pathologically demonstrated BCG-unresponsive, high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without papillary component, any T1, or Ta high-grade lesions
  • Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

  • Sign of locally advanced disease or metastatic bladder cancer
  • Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
  • Prior immuno-oncology therapy

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519256


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email ClinicalTrials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Hide Study Locations
Locations
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United States, Arizona
Local Institution Not yet recruiting
Phoenix, Arizona, United States, 85054
Contact: Site 0024         
United States, California
USC Norris Comprehensive Cancer Center Active, not recruiting
Los Angeles, California, United States, 90033
Local Institution Not yet recruiting
Riverside, California, United States, 92505
Contact: Site 0081         
Local Institution Not yet recruiting
San Francisco, California, United States, 94158
Contact: Site 0087         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Roger Li, Site 0125    888-663-3488      
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Viraj Master, Site 0056    404-778-3840      
United States, Illinois
The University Of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Randy Sweis, Site 0023    773-834-1580      
United States, Kansas
Local Institution Not yet recruiting
Westwood, Kansas, United States, 66205
Contact: Site 0119         
Wichita Urology Group Recruiting
Wichita, Kansas, United States, 67226
Contact: Gregory Byrd, Site 0090         
United States, Louisiana
Local Institution Withdrawn
Shreveport, Louisiana, United States, 71106
United States, Maryland
Local Institution Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Site 0001         
United States, Michigan
University Of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Samuel Kaffenberger, Site 0077    734-615-5180      
United States, Minnesota
University Of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Badrinath Konety, Site 0032    612-626-6541      
United States, Nebraska
Adult & Pediatric Urology Recruiting
Omaha, Nebraska, United States, 68114
Contact: Andrew Trainer, Site 0040    402-399-7892      
United States, New Jersey
Deleware Valley Urology, LLC Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Gordon Brown, Site 0042    856-673-1613      
United States, New York
Laura & Isaac Perlmutter Cancer Center Recruiting
New York, New York, United States, 10016
Contact: Arjun Balar, Site 0051    212-731-5820      
Local Institution Withdrawn
New York, New York, United States, 10032
Local Institution Withdrawn
New York, New York, United States, 10065
United States, Ohio
James Cancer Hospital Recruiting
Columbus, Ohio, United States, 43212
Contact: Kamal Pohar, Site 0058    614-366-9086      
United States, Oregon
Local Institution Not yet recruiting
Springfield, Oregon, United States, 97477
Contact: Site 0037         
United States, Pennsylvania
MidLantic Urology Recruiting
Bala-Cynwyd, Pennsylvania, United States, 19004
Contact: Laurence Belkoff, Site 0036         
Local Institution Withdrawn
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Medical University Of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Theodore Gourdin, Site 0049    843-792-9321      
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Neal Shore, Site 0002         
United States, Tennessee
Erlanger Health System Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Robert Graham, Site 0057    423-778-2982      
Local Institution Withdrawn
Nashville, Tennessee, United States, 37232
United States, Texas
Urology Clinics Of North Texas, Pa Recruiting
Dallas, Texas, United States, 75231
Contact: James Cochran, Site 0043    214-580-1391      
Local Institution Not yet recruiting
Houston, Texas, United States, 77030
Contact: Site 0048         
Local Institution Not yet recruiting
Houston, Texas, United States, 77030
Contact: Site 0140         
Local Institution Not yet recruiting
Lubbock, Texas, United States, 79415
Contact: Site 0047         
Urology San Antonio Research, Pa Recruiting
San Antonio, Texas, United States, 78229
Contact: Daniel Saltzstein, Site 0039         
United States, Virginia
Local Institution Withdrawn
Virginia Beach, Virginia, United States, 23462
United States, Washington
Local Institution Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Site 0141         
Argentina
Instituto Medico Especializado Alexander Fleming Recruiting
Capital Federal, Buenos Aires, Argentina, 1426
Contact: Juan Sade, Site 0068    +541132218900      
Local Institution Recruiting
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1118
Contact: Site 0089         
Hospital Britanico De Buenos Aires Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1280
Contact: Ernesto Korbenfeld, Site 0065    +541143096897      
Clinica Viedma S.A. Recruiting
Viedma, RIO Negro, Argentina, 8500
Contact: Ruben Kowalyszyn, Site 0066    +542920424417      
Local Institution Not yet recruiting
Cordoba, Argentina, 5000
Contact: Site 0067         
Brazil
Local Institution Recruiting
Fortaleza, Ceara, Brazil, 60130-241
Contact: Site 0072         
Local Institution Recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 91350-200
Contact: Site 0073         
Local Institution Not yet recruiting
Campinas, SAN Paulo, Brazil, 13075-460
Contact: Site 0075         
Local Institution Recruiting
Itacorubi, Florianopolis, Santa Catarina, Brazil, 88034
Contact: Site 0071         
Local Institution Recruiting
Jau, SAO Paulo, Brazil, 17210-080
Contact: Site 0078         
Local Institution Recruiting
Sao Paulo, Brazil, 01246-000
Contact: Site 0074         
Canada, Newfoundland and Labrador
Local Institution Withdrawn
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Local Institution Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Site 0086         
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 1X6
Contact: Site 0084         
Canada, Quebec
Local Institution Withdrawn
Sherbrooke, Quebec, Canada, J1H 5N4
Canada
Local Institution Recruiting
Quebec, Canada, G1R 2J6
Contact: Site 0046         
Chile
Fundacion Arturo Lopez Perez Recruiting
Santiago, Metropolitana, Chile
Contact: Pamela Salman, Site 0069    +5624457254      
China, Beijing
Local Institution Not yet recruiting
Beijing, Beijing, China, 100034
Contact: Site 0131         
Local Institution Not yet recruiting
Beijing, Beijing, China, 100142
Contact: Site 0116         
Local Institution Not yet recruiting
Beijing, Beijing, China, 100191
Contact: Site 0099         
China, Beijng
Local Institution Not yet recruiting
Beijing, Beijng, China, 100021
Contact: Site 0128         
China, Chongqing
Local Institution Not yet recruiting
Chongqing, Chongqing, China, 400030
Contact: Site 0129         
China, Fujian
Local Institution Not yet recruiting
Fuzhou, Fujian, China, 350001
Contact: Site 0108         
China, Guangdong
Local Institution Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Site 0117         
China, Jiangsu
Local Institution Not yet recruiting
Nanjing, Jiangsu, China, 210008
Contact: Site 0102         
China, Jiangxi
Local Institution Not yet recruiting
Nanchang, Jiangxi, China
Contact: Site 0109         
China, Shadong
Local Institution Not yet recruiting
Jinan, Shadong, China, 250012
Contact: Site 0112         
China, Shandong
Local Institution Not yet recruiting
Yantai, Shandong, China, 264000
Contact: Site 0111         
China, Shanghai
Local Institution Not yet recruiting
Shanghai, Shanghai, China, 200025
Contact: Site 0098         
Local Institution Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Site 0094         
Local Institution Not yet recruiting
Shanghai, Shanghai, China, 200040
Contact: Site 0097         
Local Institution Not yet recruiting
Shanghai, Shanghai, China, 200433
Contact: Site 0124         
China, Sichuan
Local Institution Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: Site 0120         
China, Tianjin
Local Institution Not yet recruiting
Tianjin, Tianjin, China, 300211
Contact: Site 0133         
China, Zhejiang
Local Institution Not yet recruiting
Hang'zhou, Zhejiang, China, 310000
Contact: Site 0126         
China
Local Institution Not yet recruiting
Shanghai, China, 200032
Contact: Site 0095         
France
Chu Angers Recruiting
Angers, France, 49100
Contact: Pierre Bigot, Site 0028         
Local Institution Recruiting
Bordeaux, France, 33000
Contact: Site 0031         
Local Institution Recruiting
LILLE Cedex, France, 59037
Contact: Site 0088         
Local Institution Not yet recruiting
Strasbourg Cedex, France, 67091
Contact: Site 0091         
Local Institution Recruiting
Suresnes, France, 92151
Contact: Site 0027         
Hong Kong
Local Institution Recruiting
Hong Kong, Hong Kong
Contact: Site 0093         
Italy
IRCCS Istituto Nazionale Tumori Milano Recruiting
Milano, Italy, 20133
Contact: Andrea Necchi, Site 0021    +390223901      
Local Institution Withdrawn
Modena, Italy, 41100
Instituto Nazionale Tumori Fondazione G. Pascale Recruiting
Napoli, Italy, 80131
Contact: Rosa Tambaro, Site 0022    +390815903111      
Azienda Ospedaliera Universitaria Pisana Recruiting
Pisa, Italy, 56126
Contact: Luca Galli, Site 0020    +390458124848      
Mexico
Centro De Estudios Y Prevencion Del Cancer A. C. Active, not recruiting
Tuxtla Gutierrez, Chiapas, Mexico, 290838
Cryptex Investigacion Clinica Sa de Cv Active, not recruiting
Ciudad de Mexico, Distrito Federal, Mexico, 06100
Local Institution Withdrawn
Df, Distrito Federal, Mexico, 06720
Netherlands
Local Institution Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Site 0004         
Local Institution Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Site 0003         
Local Institution Recruiting
Utrecht, Netherlands, 3584CX
Contact: Site 0005         
Russian Federation
Local Institution Recruiting
Omsk, Russian Federation, 644013
Contact: Site 0070         
Local Institution Recruiting
Saint-Petersburg, Russian Federation, 194044
Contact: Site 0054         
Spain
Local Institution Recruiting
Barcelona, Spain, 08025
Contact: Site 0034         
Local Institution Recruiting
Madrid, Spain, 28041
Contact: Site 0035         
Local Institution Recruiting
Malaga, Spain, 29010
Contact: Site 0033         
Local Institution Not yet recruiting
Santander, Spain, 39008
Contact: Site 0139         
Local Institution Not yet recruiting
Valencia, Spain, 46010
Contact: Site 0136         
Turkey
Local Institution Not yet recruiting
Istanbul, Turkey, 34000
Contact: Site 0079         
Local Institution Not yet recruiting
Istanbul, Turkey, 34214
Contact: Site 0082         
Local Institution Not yet recruiting
Istanbul, Turkey, 34300
Contact: Site 0080         
United Kingdom
Local Institution Not yet recruiting
Plymouth, Devon, United Kingdom, PL6 8DH
Contact: Site 0135         
Local Institution Recruiting
Chelmsford, Essex, United Kingdom, CM1 7ET
Contact: Site 0011         
Local Institution Recruiting
London, Greater London, United Kingdom, N18 1QX
Contact: Site 0012         
Local Institution Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Site 0013         
Local Institution Recruiting
Lancaster, United Kingdom, LA1 4RP
Contact: Site 0015         
Local Institution Not yet recruiting
London, United Kingdom, NW1 2BU
Contact: Site 0016         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03519256     History of Changes
Other Study ID Numbers: CA209-9UT
2017-003581-27 ( EudraCT Number )
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents