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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

Description

To learn more about this study, visit https://www.bmsstudyconnect.com/content/studyconnect/us/en/clinical-trials/NCT03519256.html?cid=v_597932

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
Not yet recruiting Site 0024

USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Active, not recruiting
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

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
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

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 Badrinath Konety, Site 0032
612-626-6541
Adult & Pediatric Urology
Omaha, Nebraska 68114
United States
Recruiting Andrew Trainer, Site 0040
402-399-7892
New Jersey Urology
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
Not yet recruiting Site 0037

MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004
United States
Recruiting Laurence Belkoff, 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
843-792-9321
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
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
Local Institution
Houston, Texas 77030
United States
Not yet recruiting Site 0140

MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Ashish Kamat, Site 0048
713-563-7458
Local Institution
Lubbock, Texas 79415
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
Instituto Medico Especializado Alexander Fleming
Capital Federal, Buenos Aires 1426
Argentina
Recruiting Juan Sade, Site 0068
+541132218900
Local Institution
Ciudad Autonoma Buenos Aires, Buenos Aires 1118
Argentina
Recruiting Site 0089

Hospital Britanico De Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires 1280
Argentina
Recruiting Ernesto Korbenfeld, Site 0065
+541143096897
Clinica Viedma S.A.
Viedma, RIO Negro 8500
Argentina
Recruiting Ruben Kowalyszyn, Site 0066
+542920424417
Local Institution
Cordoba, 5000
Argentina
Not yet recruiting Site 0067

Local Institution
Fortaleza, Ceara 60130-241
Brazil
Recruiting Site 0072

Local Institution
Porto Alegre, RIO Grande DO SUL 91350-200
Brazil
Recruiting Site 0073

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

Local Institution
Itacorubi, Florianopolis, Santa Catarina 88034
Brazil
Recruiting Site 0071

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

Local Institution
Sao Paulo, 01246-000
Brazil
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 1X6
Canada
Recruiting Site 0084

Local Institution
Sherbrooke, Quebec J1H 5N4
Canada
Withdrawn
Local Institution
Quebec, G1R 2J6
Canada
Recruiting Site 0046

Fundacion Arturo Lopez Perez
Santiago, Metropolitana
Chile
Recruiting Pamela Salman, Site 0069
+5624457254
Local Institution
Beijing, Beijing 100034
China
Not yet recruiting Site 0131

Local Institution
Beijing, Beijing 100142
China
Not yet recruiting Site 0116

Local Institution
Beijing, Beijing 100191
China
Not yet recruiting Site 0099

Local Institution
Beijing, Beijng 100021
China
Not yet recruiting Site 0128

Local Institution
Chongqing, Chongqing 400030
China
Not yet recruiting Site 0129

Local Institution
Fuzhou, Fujian 350001
China
Not yet recruiting Site 0108

Local Institution
Guangzhou, Guangdong 510080
China
Not yet recruiting Site 0117

Local Institution
Nanjing, Jiangsu 210008
China
Not yet recruiting Site 0102

Local Institution
Nanchang, Jiangxi
China
Not yet recruiting Site 0109

Local Institution
Jinan, Shadong 250012
China
Not yet recruiting Site 0112

Local Institution
Yantai, Shandong 264000
China
Not yet recruiting Site 0111

Local Institution
Shanghai, Shanghai 200025
China
Not yet recruiting Site 0098

Local Institution
Shanghai, Shanghai 200032
China
Not yet recruiting Site 0094

Local Institution
Shanghai, Shanghai 200040
China
Not yet recruiting Site 0097

Local Institution
Shanghai, Shanghai 200433
China
Not yet recruiting Site 0124

Local Institution
Chengdu, Sichuan 610041
China
Not yet recruiting Site 0120

Local Institution
Tianjin, Tianjin 300211
China
Not yet recruiting Site 0133

Local Institution
Hang'zhou, Zhejiang 310000
China
Not yet recruiting Site 0126

Local Institution
Shanghai, 200032
China
Not yet recruiting Site 0095

Chu Angers
Angers, 49100
France
Recruiting Pierre Bigot, Site 0028

Local Institution
Bordeaux, 33000
France
Recruiting Site 0031

Local Institution
LILLE Cedex, 59037
France
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
Recruiting Site 0093

IRCCS Istituto Nazionale Tumori Milano
Milano, 20133
Italy
Recruiting Andrea Necchi, 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
Comite Mexicano para la Prevenion de la Osteoporosis A.C.
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
Recruiting Site 0070

Local Institution
Saint-Petersburg, 194044
Russian Federation
Recruiting Site 0054

Local Institution
Barcelona, 08025
Spain
Recruiting Site 0034

Local Institution
Madrid, 28041
Spain
Recruiting Site 0035

Local Institution
Malaga, 29010
Spain
Recruiting Site 0033

Local Institution
Santander, 39008
Spain
Not yet recruiting Site 0139

Local Institution
Valencia, 46010
Spain
Not yet 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
Southampton, Hampshire SO16 6YD
United Kingdom
Recruiting Site 0013

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

Local Institution
London, N18 1QX
United Kingdom
Recruiting Site 0012

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