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BRIEF TITLE: 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

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

Org Study ID: CA209-9UT
Secondary ID: 2017-003581-27
NCT ID: NCT03519256
NCT Alias:

Sponsor: Bristol-Myers Squibb - Industry
Source: 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

Overal Status	Start Date	Phase	Study Type
Recruiting	May 25, 2018	Phase 2	Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Proportion of carcinoma in situ (CIS) participants with complete response (CR), per Pathology Review Committee (PRC)

Primary Outcome 1 - Time Frame: Up to 5 years

Primary Outcome 2 - Measure: Duration of complete response (DOCR), per PRC, in CIS participants with CR

Primary Outcome 2 - Time Frame: Up to 5 years

Condition:

Bladder Cancer
Bladder Tumors
Neoplasms, Bladder

Eligibility

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

Inclusion Criteria:

- Pathologically demonstrated BCG-unresponsive, carcinoma in situ (CIS)-containing
high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without
papillary component

- 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:

- 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,

Phone: please email

Email: ClinicalTrials@bms.com

Link: BMS Clinical Trial Information

Locations

Facility	Status	Contact
Local Institution Phoenix, Arizona 85054 United States	Not yet recruiting	Site 0024
USC Norris Comprehensive Cancer Center Los Angeles, California 90033 United States	Active, not recruiting
Kaiser Permanente Medical Group - Southern California Riverside, California 92505 United States	Recruiting	Helen Moon, Site 0081 800-398-3996
Local Institution San Francisco, California 94158 United States	Not yet recruiting	Site 0087
Moffitt Cancer Center Tampa, Florida 33612 United States	Recruiting	Roger Li, Site 0125 888-663-3488
Emory University Atlanta, Georgia 30322 United States	Recruiting	Viraj Master, Site 0056 404-778-3840
The University Of Chicago Chicago, Illinois 60637 United States	Recruiting	Randy Sweis, Site 0023 773-834-1580
Local Institution Westwood, Kansas 66205 United States	Withdrawn
Wichita Urology Group Wichita, Kansas 67226 United States	Recruiting	Gregory Byrd, Site 0090 316-636-6141
Local Institution Shreveport, Louisiana 71106 United States	Withdrawn
Johns Hopkins University Baltimore, Maryland 21287 United States	Recruiting	Noah Hahn, Site 0001 410-955-9797
University Of Michigan Ann Arbor, Michigan 48109 United States	Recruiting	Samuel Kaffenberger, Site 0077 734-615-5180
University Of Minnesota Minneapolis, Minnesota 55455 United States	Recruiting	Joseph Zabell, Site 0032 612-626-6541
Adult & Pediatric Urology Omaha, Nebraska 68114 United States	Recruiting	Andrew Trainer, Site 0040 402-399-7892
Local Institution New Brunswick, New Jersey 08903 United States	Not yet recruiting	Site 0144
Deleware Valley Urology, LLC Voorhees, New Jersey 08043 United States	Recruiting	Gordon Brown, Site 0042 856-673-1613
Laura & Isaac Perlmutter Cancer Center New York, New York 10016 United States	Recruiting	Arjun Balar, Site 0051 212-731-5820
Local Institution New York, New York 10032 United States	Withdrawn
Local Institution New York, New York 10065 United States	Withdrawn
James Cancer Hospital Columbus, Ohio 43212 United States	Recruiting	Kamal Pohar, Site 0058 614-366-9086
Local Institution Springfield, Oregon 97477 United States	Withdrawn
MidLantic Urology Bala-Cynwyd, Pennsylvania 19026 United States	Recruiting	Laurence Belkoff, Site 0036 610-667-0458
Local Institution Hershey, Pennsylvania 17033 United States	Withdrawn
Medical University Of South Carolina Charleston, South Carolina 29425 United States	Recruiting	Theodore Gourdin, Site 0049 843-792-9321
Carolina Urologic Research Center Myrtle Beach, South Carolina 29572 United States	Recruiting	Neal Shore, Site 0002 843-449-1010
Erlanger Health System Chattanooga, Tennessee 37403 United States	Recruiting	Robert Graham, Site 0057 423-778-2982
Local Institution Nashville, Tennessee 37232 United States	Withdrawn
Urology Clinics Of North Texas, Pa Dallas, Texas 75231 United States	Recruiting	James Cochran, Site 0043 214-580-1391
Houston Methodist Hospital Houston, Texas 77030 United States	Recruiting	Raj Satkunasivam, Site 0140 346-238-6123
Local Institution Houston, Texas 77030 United States	Not yet recruiting	Site 0048
Texas Tech University Health Sciences Center Lubbock, Texas 79415 United States	Recruiting	Sanjay Awasthi, Site 0047 806-775-8597
Urology San Antonio Research, Pa San Antonio, Texas 78229 United States	Recruiting	Daniel Saltzstein, Site 0039 210-617-4116
Local Institution Virginia Beach, Virginia 23462 United States	Withdrawn
Local Institution Seattle, Washington 98195 United States	Not yet recruiting	Site 0141
Local Institution Capital Federal, Buenos Aires 1426 Argentina	Recruiting	Site 0068
Local Institution Ciudad Autonoma Buenos Aires, Buenos Aires 1118 Argentina	Recruiting	Site 0089
Local Institution Ciudad Autonoma de Buenos Aires, Buenos Aires 1280 Argentina	Recruiting	Site 0065
Local Institution Viedma, RIO Negro 8500 Argentina	Recruiting	Site 0066
Instituto Oncologico De Cordoba Cordoba, 5000 Argentina	Recruiting	Martin Richardet, Site 0067 +5435142842484
Local Institution Mendoza, 5500 Argentina	Recruiting	Site 0137
Local Institution Camperdown, New South Wales 2050 Australia	Recruiting	Site 0146
Local Institution Kogarah, New South Wales 2217 Australia	Not yet recruiting	Site 0152
Local Institution St Leonards, New South Wales 2065 Australia	Not yet recruiting	Site 0148
Local Institution Fortaleza, Ceara 60130-241 Brazil	Recruiting	Site 0072
Local Institution Curitiba, Parana 81480-580 Brazil	Not yet recruiting	Site 0151
Local Institution Porto Alegre, RIO Grande DO SUL 91350-200 Brazil	Recruiting	Site 0073
Local Institution Campinas, SAN Paulo 13075-460 Brazil	Withdrawn
Local Institution Itacorubi, Florianopolis, Santa Catarina 88034 Brazil	Recruiting	Site 0071
Local Institution Jau, SAO Paulo 17210-080 Brazil	Recruiting	Site 0078
Local Institution Rio De Janeiro, 20231-050 Brazil	Not yet recruiting	Site 0150
Local Institution Sao Paulo, 01246-000 Brazil	Recruiting	Site 0074
Local Institution Edmonton, Alberta T6R0N1 Canada	Withdrawn
Local Institution St. John's, Newfoundland and Labrador A1B 3V6 Canada	Withdrawn
North York General Hospital Toronto, Ontario M2J 1V1 Canada	Recruiting	Daniel Robson, Site 0143
Local Institution Toronto, Ontario M4N 3M5 Canada	Not yet recruiting	Site 0086
Local Institution Toronto, Ontario M5G 1X6 Canada	Recruiting	Site 0084
Local Institution Sherbrooke, Quebec J1H 5N4 Canada	Withdrawn
Local Institution Quebec, G1R 2J6 Canada	Recruiting	Site 0046
Local Institution Santiago, Metropolitana 8420383 Chile	Recruiting	Site 0154
Local Institution Santiago, Metropolitana Chile	Recruiting	Site 0069
Local Institution Beijing, Beijing 100034 China	Recruiting	Site 0131
Local Institution Beijing, Beijing 100142 China	Recruiting	Site 0116
Local Institution Beijing, Beijing 100191 China	Recruiting	Site 0099
Local Institution Beijing, Beijng 100021 China	Recruiting	Site 0128
Local Institution Chongqing, Chongqing 400030 China	Recruiting	Site 0129
Local Institution Fuzhou, Fujian 350001 China	Recruiting	Site 0108
Local Institution Guangzhou, Guangdong 510080 China	Recruiting	Site 0117
Local Institution Nanjing, Jiangsu 210008 China	Recruiting	Site 0102
Local Institution Nanchang, Jiangxi China	Recruiting	Site 0109
Local Institution Jinan, Shadong 250012 China	Recruiting	Site 0112
Local Institution Yantai, Shandong 264000 China	Recruiting	Site 0111
Local Institution Shanghai, Shanghai 200025 China	Not yet recruiting	Site 0098
Local Institution Shanghai, Shanghai 200032 China	Recruiting	Site 0094
Local Institution Shanghai, Shanghai 200040 China	Recruiting	Site 0097
Local Institution Shanghai, Shanghai 200433 China	Not yet recruiting	Site 0124
Local Institution Chengdu, Sichuan 610041 China	Recruiting	Site 0120
Local Institution Tianjin, Tianjin 300211 China	Recruiting	Site 0133
Local Institution Hang'zhou, Zhejiang 310000 China	Recruiting	Site 0126
Local Institution Shanghai, 200032 China	Withdrawn
Chu Angers Angers, 49100 France	Recruiting	Pierre Bigot, Site 0028 +33665807200
Hopital Pellegrin Bordeaux, 33000 France	Recruiting	Gregoire Robert, Site 0031 +33556795547
Hopital Claude Huriez LILLE Cedex, 59037 France	Recruiting	Arnauld Villers, Site 0088 +33320444235
Nouvel Hopital Civil Chru De Strasbourg Strasbourg Cedex, 67091 France	Recruiting	Philippe Barthelemy, Site 0091
Hopital Foch Suresnes, 92151 France	Recruiting	Thierry Lebret, Site 0027 +33146252487
Local Institution Hong Kong, Hong Kong	Recruiting	Site 0093
IRCCS Istituto Nazionale Tumori Milano Milano, 20133 Italy	Recruiting	Daniele Raggi, Site 0021 +390223901
Local Institution Modena, 41100 Italy	Withdrawn
Instituto Nazionale Tumori Fondazione G. Pascale Napoli, 80131 Italy	Recruiting	Rosa Tambaro, Site 0022 +390815903111
Azienda Ospedaliera Universitaria Pisana Pisa, 56126 Italy	Recruiting	Luca Galli, Site 0020 +390458124848
Centro De Estudios Y Prevencion Del Cancer A. C. Tuxtla Gutierrez, Chiapas 290838 Mexico	Active, not recruiting
Cryptex Investigacion Clinica Sa de Cv Ciudad de Mexico, Distrito Federal 06100 Mexico	Active, not recruiting
Local Institution Df, Distrito Federal 06720 Mexico	Withdrawn
Local Institution Amsterdam, 1066 CX Netherlands	Recruiting	Site 0004
Local Institution Nijmegen, 6525 GA Netherlands	Recruiting	Site 0003
Local Institution Utrecht, 3584CX Netherlands	Recruiting	Site 0005
Local Institution Omsk, 644013 Russian Federation	Active, not recruiting
Local Institution Saint-Petersburg, 194044 Russian Federation	Recruiting	Site 0054
Local Institution Saint-Petersburg, 197082 Russian Federation	Recruiting	Site 0153
Local Institution Barcelona, 08025 Spain	Withdrawn
Local Institution Madrid, 28041 Spain	Recruiting	Site 0035
Local Institution Malaga, 29010 Spain	Recruiting	Site 0033
Local Institution Santander, 39008 Spain	Recruiting	Site 0139
Local Institution Valencia, 46010 Spain	Recruiting	Site 0136
Local Institution Istanbul, 34000 Turkey	Not yet recruiting	Site 0079
Local Institution Istanbul, 34214 Turkey	Not yet recruiting	Site 0082
Local Institution Istanbul, 34300 Turkey	Not yet recruiting	Site 0080
Local Institution Plymouth, Devon PL6 8DH United Kingdom	Not yet recruiting	Site 0135
Local Institution Chelmsford, Essex CM1 7ET United Kingdom	Recruiting	Site 0011
Local Institution London, Greater London N18 1QX United Kingdom	Recruiting	Site 0012
Local Institution Southampton, Hampshire SO16 6YD United Kingdom	Recruiting	Site 0013
Local Institution Lancaster, LA1 4RP United Kingdom	Recruiting	Site 0015
Local Institution London, NW1 2BU United Kingdom	Withdrawn

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