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


Condition: Bladder Cancer, Bladder Tumors, Neoplasms, Bladder

Intervention:

  • Biological: Nivolumab
  • Biological: BCG
  • Drug: BMS-986205

Purpose: A study to evaluate Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03519256

Sponsor: Bristol-Myers Squibb

Primary Outcome Measures:

  • Measure: Proportion of carcinoma in situ (CIS) participants with complete response (CR), per Pathology Review Committee (PRC)
  • Time Frame: Up to 5 years
  • Safety Issue:
  • Measure: Duration of complete response (DOCR), per PRC, in CIS participants with CR
  • Time Frame: Up to 5 years
  • Safety Issue:
  • Measure: Event Free Survival (EFS), per PRC, for all non-CIS participants
  • Time Frame: Up to 5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression-free Survival (PFS)
  • Time Frame: Up to 5 years
  • Safety Issue:
  • Measure: Incidence of Adverse Events (AEs)
  • Time Frame: Up to 15 months
  • Safety Issue:
  • Measure: Incidence of Serious Adverse Events (SAEs)
  • Time Frame: Up to 15 months
  • Safety Issue:
  • Measure: Incidence of AEs leading to discontinuation
  • Time Frame: Up to 15 months
  • Safety Issue:
  • Measure: Incidence of deaths
  • Time Frame: Up to 5 years
  • Safety Issue:
  • Measure: Incidence of laboratory abnormalities
  • Time Frame: Up to 15 months
  • Safety Issue:

Estimated Enrollment: 436

Study Start Date: May 25, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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:

  • 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

Contact:

  • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
  • please email

Locations:

  • Local Institution
  • Phoenix Arizona 85054 United States
  • USC Norris Comprehensive Cancer Center
  • Los Angeles California 90033 United States
  • Local Institution
  • Riverside California 92505 United States
  • Local Institution
  • San Francisco California 94158 United States
  • Local Institution
  • Tampa Florida 33612 United States
  • Emory University
  • Atlanta Georgia 30322 United States
  • The University Of Chicago
  • Chicago Illinois 60637 United States
  • Local Institution
  • Westwood Kansas 66205 United States
  • Wichita Urology Group
  • Wichita Kansas 67226 United States
  • Local Institution
  • Shreveport Louisiana 71106 United States
  • Local Institution
  • Baltimore Maryland 21287 United States
  • Local Institution
  • Ann Arbor Michigan 48109 United States
  • Local Institution
  • Minneapolis Minnesota 55455 United States
  • Adult & Pediatric Urology
  • Omaha Nebraska 68124 United States
  • Deleware Valley Urology, LLC
  • Voorhees New Jersey 08043 United States
  • Local Institution
  • New York New York 10016 United States
  • Local Institution
  • New York New York 10032 United States
  • Local Institution
  • New York New York 10065 United States
  • Local Institution
  • Columbus Ohio 43210 United States
  • Local Institution
  • Springfield Oregon 97477 United States
  • MidLantic Urology
  • Bala-Cynwyd Pennsylvania 19004 United States
  • Local Institution
  • Hershey Pennsylvania 17033 United States
  • Medical University Of South Carolina
  • Charleston South Carolina 29425 United States
  • Carolina Urologic Research Center
  • Myrtle Beach South Carolina 29572 United States
  • Erlanger Health System
  • Chattanooga Tennessee 37403 United States
  • Local Institution
  • Nashville Tennessee 37232 United States
  • Urology Clinics Of North Texas, Pa
  • Dallas Texas 75231 United States
  • MD Anderson Cancer Center
  • Houston Texas 77030 United States
  • Local Institution
  • Lubbock Texas 79430-0002 United States
  • Urology San Antonio Research, Pa
  • San Antonio Texas 78229 United States
  • Local Institution
  • Virginia Beach Virginia 23462 United States
  • Instituto Medico Especializado Alexander Fleming
  • Capital Federal Buenos Aires 1426 Argentina
  • Local Institution
  • Ciudad Autonoma Buenos Aires Buenos Aires 1118 Argentina
  • Hospital Britanico De Buenos Aires
  • Ciudad Autonoma de Buenos Aires Buenos Aires 1280 Argentina
  • Clinica Viedma S.A.
  • Viedma RIO Negro 8500 Argentina
  • Local Institution
  • Cordoba 5000 Argentina
  • Local Institution
  • Fortaleza Ceara 60130-241 Brazil
  • Local Institution
  • Porto Alegre RIO Grande DO SUL 91350-200 Brazil
  • Local Institution
  • Campinas SAN Paulo 13075-460 Brazil
  • Local Institution
  • Itacorubi, Florianopolis Santa Catarina 88034 Brazil
  • Local Institution
  • Jau SAO Paulo 17210-080 Brazil
  • Local Institution
  • Sao Paulo 01246-000 Brazil
  • Local Institution
  • St. John's Newfoundland and Labrador A1B 3V6 Canada
  • Local Institution
  • Toronto Ontario M4N 3M5 Canada
  • Local Institution
  • Toronto Ontario M5G 1X6 Canada
  • Local Institution
  • Sherbrooke Quebec J1H 5N4 Canada
  • Local Institution
  • Quebec G1R 2J6 Canada
  • Local Institution
  • Santiago Metropolitana Chile
  • Local Institution
  • Beijing Beijng 100021 China
  • Local Institution
  • Guangzhou Guangdong 510080 China
  • Local Institution
  • Nanjing Jiangsu 210008 China
  • Local Institution
  • Nanchang Jiangxi China
  • Local Institution
  • Shanghai Shanghai 200025 China
  • Local Institution
  • Shanghai Shanghai 200032 China
  • Local Institution
  • Shanghai Shanghai 200040 China
  • Local Institution
  • Shanghai Shanghai 200433 China
  • Local Institution
  • Hangzhou Zhejiang 310003 China
  • Local Institution
  • Beijing 100083 China
  • Local Institution
  • Beijing 100142 China
  • Local Institution
  • Angers 49100 France
  • Local Institution
  • Bordeaux 33000 France
  • Local Institution
  • LILLE Cedex 59037 France
  • Local Institution
  • Strasbourg Cedex 67091 France
  • Local Institution
  • Suresnes 92151 France
  • Local Institution
  • Hong Kong Hong Kong
  • IRCCS Istituto Nazionale Tumori Milano
  • Milano 20133 Italy
  • Local Institution
  • Modena 41100 Italy
  • Local Institution
  • Napoli 80131 Italy
  • Azienda Ospedaliera Universitaria Pisana
  • Pisa 56126 Italy
  • Local Institution
  • Tuxtla Gutierrez Chiapas 290838 Mexico
  • Local Institution
  • Ciudad de Mexico Distrito Federal 06100 Mexico
  • Local Institution
  • Df Distrito Federal 06720 Mexico
  • Local Institution
  • Amsterdam 1066 CX Netherlands
  • Local Institution
  • Nijmegen 6525 GA Netherlands
  • Local Institution
  • Utrecht 3584CX Netherlands
  • Local Institution
  • Omsk 644013 Russian Federation
  • Local Institution
  • Saint-Petersburg 194044 Russian Federation
  • Local Institution
  • Barcelona 08025 Spain
  • Hosp Univer 12 De Octubre
  • Madrid 28041 Spain
  • Hospital Universitario Virgen De La Victoria
  • Malaga 29010 Spain
  • Local Institution
  • Istanbul 34000 Turkey
  • Local Institution
  • Istanbul 34214 Turkey
  • Local Institution
  • Istanbul 34300 Turkey
  • Local Institution
  • Chelmsford Essex CM1 7ET United Kingdom
  • Local Institution
  • Lancaster LA1 4RP United Kingdom
  • Local Institution
  • London N18 1QX United Kingdom
  • Local Institution
  • London NW1 2BU United Kingdom
  • Local Institution
  • Southampton SO16 6YD United Kingdom

View trial on ClinicalTrials.gov


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