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BRIEF TITLE: Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG

A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG


  • Org Study ID: CA209-7G8
  • Secondary ID:
  • NCT ID: NCT04149574
  • NCT Alias:
  • Sponsor: Bristol-Myers Squibb - Industry
  • Source: Bristol-Myers Squibb

Brief Summary

A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

Overal Status Start Date Phase Study Type
Recruiting December 9, 2019 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Event Free Survival (EFS)

Primary Outcome 1 - Time Frame: approximately 3 years

Condition:

  • Bladder Cancer

Eligibility

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

Inclusion:

- Predominant histologic component (> 50%) must be urothelial (transitional cell)
carcinoma

- Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as
BCG unresponsive

- Histologically confirmed persistent or recurrent high-risk non-muscle-invasive
urothelial carcinoma (UC)

- Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6
doses)

- Sufficient tissue for both biomarker analysis and central pathology review committee
(PRC) confirmation of diagnosis

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

- Women of child bearing potential (WOCBP) and men with WOCBP partners must agree to
follow contraceptive requirements

Exclusion Criteria

- Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic
UC

- UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters)
within 24 months of enrollment

- UC and/or CIS in the prostatic urethra within 12 months of enrollment

- Prior surgery (other than transurethral resection of the bladder tumor
(TURBT)/biopsies) for bladder cancer; prior radiation therapy, or systemic
chemotherapy or immunotherapy for bladder cancer or UC

Other inclusion/exclusion criteria 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: Clinical.Trials@bms.com

Link: BMS Clinical Trial Information

Locations

Facility Status Contact
Local Institution
Tucson, Arizona 85723
United States
Not yet recruiting Site 0112

Local Institution
Aurora, Colorado 80045
United States
Not yet recruiting Site 0070

Local Institution
New Haven, Connecticut 06520
United States
Not yet recruiting Site 0036

Local Institution
Newark, Delaware 19713
United States
Not yet recruiting Site 0085

Local Institution
Washington, District of Columbia 20422
United States
Not yet recruiting Site 0113

Local Institution
Boise, Idaho 83712
United States
Not yet recruiting Site 0109

Local Institution
Chicago, Illinois 60637
United States
Not yet recruiting Site 0007

Local Institution
Bronx, New York 10467
United States
Not yet recruiting Site 0084

Local Institution
Fort Worth, Texas 76104
United States
Not yet recruiting Site 0092

Local Institution
Temple, Texas 76508
United States
Not yet recruiting Site 0015

Local Institution
Sydney, New South Wales 2050
Australia
Not yet recruiting Site 0002

Local Institution
Woolloongabba, Queensland 4012
Australia
Not yet recruiting Site 0001

Local Institution
Linz, 4020
Austria
Not yet recruiting Site 0097

Local Institution
Salzburger, 5020
Austria
Not yet recruiting Site 0104

Local Institution
Wels, 4600
Austria
Not yet recruiting Site 0098

Local Institution
Wien, 1090
Austria
Not yet recruiting Site 0099

Local Institution
Uberlandia, Minas Gerais 38408-150
Brazil
Not yet recruiting Site 0050

Local Institution
Porto Alegre, RIO Grande DO SUL 90035-001
Brazil
Not yet recruiting Site 0048

Local Institution
Itajai, Santa Catarina 88301-220
Brazil
Not yet recruiting Site 0047

Local Institution
Rio de Janeiro, 22793-080
Brazil
Not yet recruiting Site 0049

Local Institution
Toronto, Ontario M5G 1X6
Canada
Not yet recruiting Site 0017

Local Institution
Montreal, Quebec H2X 0C2
Canada
Not yet recruiting Site 0038

Local Institution
Montreal, Quebec H3T 1E2
Canada
Not yet recruiting Site 0037

CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski
Rimouski, Quebec G5L 5T1
Canada
Recruiting Sophie Savary Belanger, Site 0012

Local Institution
Angers Cedex 10, 49933
France
Not yet recruiting Site 0042

Local Institution
DIJON Cedex, 21079
France
Not yet recruiting Site 0106

Local Institution
Lille, 59000
France
Not yet recruiting Site 0045

Local Institution
Lyon Cedex 08, 69373
France
Not yet recruiting Site 0043

Local Institution
Nice, 06189
France
Not yet recruiting Site 0076

Local Institution
Strasbourg Cedex, 67091
France
Not yet recruiting Site 0041

Local Institution
Toulouse Cedex 9, 31059
France
Not yet recruiting Site 0046

Local Institution
Villejuif, 94800
France
Not yet recruiting Site 0040

Local Institution
Aachen, 52074
Germany
Not yet recruiting Site 0110

Local Institution
Herne, 44625
Germany
Not yet recruiting Site 0094

Local Institution
Jena, 07747
Germany
Not yet recruiting Site 0093

Local Institution
Koeln, 50968
Germany
Not yet recruiting Site 0105

Local Institution
Trier, 54292
Germany
Not yet recruiting Site 0095

Local Institution
Wilton, Cork T12 DC4A
Ireland
Not yet recruiting Site 0082

Local Institution
Tallaght, Dublin
Ireland
Not yet recruiting Site 0086

Local Institution
Arnhem, 6815 AD
Netherlands
Not yet recruiting Site 0054

Local Institution
Leeuwarden, 8934 AD
Netherlands
Not yet recruiting Site 0027

Local Institution
Leiden, 2333 ZA
Netherlands
Not yet recruiting Site 0053

Local Institution
Niewegein, 3435 CM
Netherlands
Not yet recruiting Site 0030

Local Institution
Rotterdam, 3015 GD
Netherlands
Not yet recruiting Site 0028

Local Institution
Singapore, 119074
Singapore
Not yet recruiting Site 0035

Local Institution
Singapore, 169610
Singapore
Not yet recruiting Site 0034

Local Institution
Badajoz, 06006
Spain
Not yet recruiting Site 0061

Local Institution
Badalona-barcelona, 08916
Spain
Not yet recruiting Site 0060

Local Institution
Madrid, 28041
Spain
Not yet recruiting Site 0055

Local Institution
Malaga, 29010
Spain
Not yet recruiting Site 0056

Local Institution
Pamplona, 31008
Spain
Not yet recruiting Site 0096

Local Institution
Sabadell, 08208
Spain
Not yet recruiting Site 0059

Local Institution
Santander, 39008
Spain
Not yet recruiting Site 0057

Local Institution
Valencia, 46010
Spain
Not yet recruiting Site 0058

Local Institution
Norrkoping, 601 82
Sweden
Not yet recruiting Site 0087

Local Institution
Umea, 901 85
Sweden
Not yet recruiting Site 0083

Local Institution
Manchester, Greater Manchester M20 4BX
United Kingdom
Not yet recruiting Site 0029

Local Institution
Glasgow, Lanarkshire G12 0YN
United Kingdom
Not yet recruiting Site 0022

Local Institution
Bournemouth, BH7 7DW
United Kingdom
Not yet recruiting Site 0078

Local Institution
Coventry, CV2 2DX
United Kingdom
Not yet recruiting Site 0077

Local Institution
Sheffield, S10 2SJ
United Kingdom
Not yet recruiting Site 0068

Local Institution
Stoke-on-Trent, ST4 6QG
United Kingdom
Not yet recruiting Site 0069