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BRIEF 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

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

Primary Outcome 3 - Measure: Event Free Survival (EFS), per PRC, for all non-CIS participants

Primary Outcome 3 - 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, 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
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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
Withdrawn
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Recruiting Sia Daneshmand, Site 0044

Local Institution
Riverside, California 92505
United States
Not yet recruiting Site 0081

Local Institution
San Francisco, California 94158
United States
Not yet recruiting Site 0087

Local Institution
Tampa, Florida 33612
United States
Not yet recruiting Site 0125

Emory University
Atlanta, Georgia 30322
United States
Recruiting Viraj Master, Site 0056

The University Of Chicago
Chicago, Illinois 60637
United States
Recruiting Randy Sweis, Site 0023
773-834-1580
Local Institution
Westwood, Kansas 66205
United States
Not yet recruiting Site 0119

Wichita Urology Group
Wichita, Kansas 67226
United States
Recruiting Gregory Byrd, Site 0090

Local Institution
Shreveport, Louisiana 71106
United States
Withdrawn
Local Institution
Baltimore, Maryland 21287
United States
Not yet recruiting Site 0001

Local Institution
Ann Arbor, Michigan 48109
United States
Not yet recruiting Site 0077

Local Institution
Minneapolis, Minnesota 55455
United States
Not yet recruiting Site 0032

Adult & Pediatric Urology
Omaha, Nebraska 68124
United States
Recruiting Andrew Trainer, Site 0040
402-399-7892
Local Institution
Voorhees, New Jersey 08043
United States
Not yet recruiting Site 0042

Local Institution
New York, New York 10016
United States
Not yet recruiting Site 0051

Local Institution
New York, New York 10032
United States
Withdrawn
Local Institution
New York, New York 10065
United States
Withdrawn
Local Institution
Columbus, Ohio 43210
United States
Not yet recruiting Site 0058

Local Institution
Springfield, Oregon 97477
United States
Not yet recruiting Site 0037

Local Institution
Bala-Cynwyd, Pennsylvania 19004
United States
Not yet recruiting Site 0036

Local Institution
Hershey, Pennsylvania 17033
United States
Withdrawn
Medical University Of South Carolina
Charleston, South Carolina 29425
United States
Recruiting Theodore Gourdin, Site 0049

Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Recruiting Neal Shore, Site 0002

Erlanger Health System
Chattanooga, Tennessee 37403
United States
Recruiting Robert Graham, Site 0057

Local Institution
Nashville, Tennessee 37232
United States
Withdrawn
Urology Clinics Of North Texas, Pa
Dallas, Texas 75231
United States
Recruiting James Cochran, Site 0043

Local Institution
Houston, Texas 77030
United States
Not yet recruiting Site 0048

Local Institution
Lubbock, Texas 79430-0002
United States
Not yet recruiting Site 0047

Urology San Antonio Research, Pa
San Antonio, Texas 78229
United States
Recruiting Daniel Saltzstein, Site 0039

Local Institution
Virginia Beach, Virginia 23462
United States
Withdrawn
Local Institution
Capital Federal, Buenos Aires 1426
Argentina
Not yet recruiting Site 0068

Local Institution
Ciudad Autonoma Buenos Aires, Buenos Aires 1118
Argentina
Not yet recruiting Site 0089

Local Institution
Ciudad Autonoma de Buenos Aires, Buenos Aires 1280
Argentina
Not yet recruiting Site 0065

Local Institution
Viedma, RIO Negro 8500
Argentina
Not yet recruiting Site 0066

Local Institution
Cordoba, 5000
Argentina
Not yet recruiting Site 0067

Local Institution
Fortaleza, Ceara 60130-241
Brazil
Not yet recruiting Site 0072

Local Institution
Porto Alegre, RIO Grande DO SUL 91350-200
Brazil
Not yet recruiting Site 0073

Local Institution
Campinas, SAN Paulo 13075-460
Brazil
Not yet recruiting Site 0075

Local Institution
Itacorubi, Florianopolis, Santa Catarina 88034
Brazil
Not yet recruiting Site 0071

Local Institution
Jau, SAO Paulo 17210-080
Brazil
Not yet recruiting Site 0078

Local Institution
Sao Paulo, 01246-000
Brazil
Not yet recruiting Site 0074

Local Institution
St. John's, Newfoundland and Labrador A1B 3V6
Canada
Withdrawn
Local Institution
Toronto, Ontario M4N 3M5
Canada
Not yet recruiting Site 0086

Local Institution
Toronto, Ontario M5G 1Z5
Canada
Not yet recruiting Site 0084

Local Institution
Sherbrooke, Quebec J1H 5N4
Canada
Withdrawn
Local Institution
Quebec, G1R 2J6
Canada
Not yet recruiting Site 0046

Local Institution
Santiago, Metropolitana
Chile
Not yet recruiting Site 0069

Local Institution
Angers, 49100
France
Recruiting Site 0028

Local Institution
Bordeaux, 33000
France
Recruiting Site 0031

Local Institution
LILLE Cedex, 59037
France
Not yet recruiting Site 0088

Local Institution
Strasbourg Cedex, 67091
France
Not yet recruiting Site 0091

Local Institution
Suresnes, 92151
France
Recruiting Site 0027

Local Institution
Hong Kong,
Hong Kong
Not yet recruiting Site 0093

IRCCS Istituto Nazionale Tumori Milano
Milano, 20133
Italy
Recruiting Andrea Necchi, Site 0021
+390223901
Local Institution
Modena, 41100
Italy
Withdrawn
Local Institution
Napoli, 80131
Italy
Not yet recruiting Site 0022

Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
Italy
Recruiting Luca Galli, Site 0020
+390458124848
Local Institution
Tuxtla Gutierrez, Chiapas 290838
Mexico
Not yet recruiting Site 0062

Local Institution
Ciudad de Mexico, Distrito Federal 06100
Mexico
Not yet recruiting Site 0055

Local Institution
Df, Distrito Federal 06720
Mexico
Withdrawn
Local Institution
Amsterdam, 1066 CX
Netherlands
Recruiting Site 0004

Local Institution
Nijmegen, 6525 GA
Netherlands
Not yet recruiting Site 0003

Local Institution
Utrecht, 3584CX
Netherlands
Recruiting Site 0005

Local Institution
Omsk, 644013
Russian Federation
Not yet recruiting Site 0070

Local Institution
Saint-Petersburg, 194044
Russian Federation
Not yet recruiting Site 0054

Local Institution
Barcelona, 08025
Spain
Not yet recruiting Site 0034

Hosp Univer 12 De Octubre
Madrid, 28041
Spain
Recruiting Felix Guerrero-Ramos, Site 0035
+34913908000
Hospital Universitario Virgen De La Victoria
Malaga, 29010
Spain
Recruiting Bernardo Herrera Imbroda, Site 0033
+34951032338
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
Chelmsford, Essex CM1 7ET
United Kingdom
Not yet recruiting Site 0011

Local Institution
Lancaster, LA1 4RP
United Kingdom
Recruiting Site 0015

Local Institution
London, N18 1QX
United Kingdom
Not yet recruiting Site 0012

Local Institution
London, NW1 2BU
United Kingdom
Not yet recruiting Site 0016

Local Institution
Southampton, SO16 6YD
United Kingdom
Not yet recruiting Site 0013