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Brief Title: Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

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

INTRODUCTION

  • Org Study ID: CA209-7G8
  • Secondary ID: N/A
  • NTC ID: NCT04149574
  • Sponsor: Bristol-Myers Squibb
BMS Clinical Trial Information, BMS Clinical Trial Patient Recruiting, FDA Safety Alerts and Recalls

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.

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

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: approximately 3 years

CONDITION

  • Bladder Cancer

ELIGIBILITY

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.

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: Bristol-Myers Squibb

Phone: please email:

Email: Clinical.Trials@bms.com

LOCATION

Facility Status Contact
Facility: Instituto Alexander Fleming
Caba, Buenos Aires 1426
Argentina
Status: Recruiting Contact: Contact
Carlos Rojas, Site 0010
+33695210535
Facility: Hospital Sirio Libanes
Capital Federal, Buenos Aires 1419
Argentina
Status: Recruiting Contact: Contact
Alejandro Acevedo Gaete, Site 0072
+33158412764
Facility: Cemic
Ciudad Autonoma Beunos Aires, Buenos Aires 1431
Argentina
Status: Recruiting Contact: Contact
Site 0121
+33140257103
Facility: Local Institution
Mar Del Plata, Buenos Aires 7600
Argentina
Status: Recruiting Contact: Contact
Site 0125
+33388115141
Facility: Clinica Viedma S.A.
Viedma, RIO Negro 8500
Argentina
Status: Recruiting Contact: Contact
Site 0133
+33142114211
Facility: Local Institution
Buenos Aires, New South Wales 1120
Argentina
Status: Recruiting Contact: Contact
Site 0122
+4923234991575
Facility: Instituto Oncologico De Cordoba
Cordoba, New South Wales 5000
Argentina
Status: Recruiting Contact: Contact
Site 0124
+4922147888466
Facility: Krankenhaus der Elisabethinen Linz GmbH
Linz, Quebec 4010
Austria
Status: Recruiting Contact: Contact
Site 0134

Facility: Universitatsklinikun Salzburg-Salzburger Landeskliniken
Salzburger, Quebec 5020
Austria
Status: Recruiting Contact: Contact
Site 0127

Facility: Klinikum Wels-Grieskirchen Gmbh
Wels, Quebec 4600
Austria
Status: Recruiting Contact: Contact
Site 0118

Facility: Medizinische Universitaet Wien
Wien, Quebec 1090
Austria
Status: Recruiting Contact: Contact
Site 0142

Facility: IC La Serena Research
La Serena, Fujian 1720430
Chile
Status: Recruiting Contact: Contact
Romain Boissier, Site 0108

Facility: Bradfordhill
Recoleta, Guangdong 2520598
Chile
Status: Recruiting Contact: Contact
Nicolas Barry Delongchamps, Site 0103

Facility: Oncocentro Apys
Vina del Mar, Guangdong 100034
Chile
Status: Recruiting Contact: Contact
Evanguelos Xylinas, Site 0111

Facility: Chu Angers
Angers Cedex 10, Kanagawa 69373
France
Status: Recruiting Contact: Contact
Site 0155

Facility: Local Institution
DIJON Cedex, Nagasaki 13385
France
Status: Recruiting Contact: Contact
Site 0149

Facility: Hopital Claude Huriez
Lille, Nara 06189
France
Status: Recruiting Contact: Contact
Site 0146

Facility: Hopital De La Conception
Marseille Cedex 05, Okayama 75018
France
Status: Recruiting Contact: Contact
Site 0164

Facility: Hopital Cochin
Paris Cedex 14, Osaka 31059
France
Status: Recruiting Contact: Contact
Site 0165

Facility: Hopital Bichat Claude Bernard
Paris Cedex 18, Osaka 94800
France
Status: Recruiting Contact: Contact
Site 0156

Facility: ICANS-Institut de cancerologie Strasbourg Europe
Strasbourg, Shizuoka 52074
France
Status: Recruiting Contact: Contact
Site 0157

Facility: Institut Gustave Roussy
Villejuif, Tokyo 07747
France
Status: Recruiting Contact: Contact
Site 0160

Facility: Marien Hospital Herne
Herne, Greater Manchester 54292
Germany
Status: Recruiting Contact: Contact
Site 0162

Facility: Universitaetsklinikum Jena
Jena, Warwickshire 12462
Germany
Status: Recruiting Contact: Contact
Site 0150

Facility: Urologie Bayenthal
Koeln, 57001
Germany
Status: Recruiting Contact: Contact
Site 0145

Facility: Krankenhaus der Barmherzigen Brueder
Trier, T12 DC4A
Germany
Status: Recruiting Contact: Contact
Site 0054

Facility: University General Hospital of Athens Attikon
Haidari, 34362
Greece
Status: Recruiting Contact: Contact
Site 0028

Facility: Interbalkan European Medical Center
Thessaloniki, 9103102
Greece
Status: Recruiting Contact: Contact
Site 0039

Facility: Local Institution
Jerusalem, 20133
Israel
Status: Recruiting Contact: Contact
Site 0087

Facility: Local Institution
Ramat-gan, 41124
Israel
Status: Recruiting Contact: Contact
Site 0083

Facility: Local Institution
Tel Aviv, 80131
Israel
Status: Recruiting Contact: N/A
Facility: Local Institution
Milano, 00168
Italy
Status: Recruiting Contact: N/A
Facility: Local Institution
Roma, 6500047
Italy
Status: Recruiting Contact: N/A
Facility: Local Institution
Arnhem, 3543 AZ
Netherlands
Status: Recruiting Contact: N/A
Facility: Local Institution
Saint-Petersburg, 08916
Russian Federation
Status: Recruiting Contact: N/A
Facility: Local Institution
Norrkoping, CV2 2DX
Sweden
Status: Recruiting Contact: N/A
Facility: Local Institution
Umea, CH63 4JY
Sweden
Status: Recruiting Contact: N/A