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A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy.
Official title: A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
518
Start Date
2020-12-07
Completion Date
2028-12-31
Last Updated
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
Cetrelimab
Participants will receive intravenous Cetrelimab.
TAR-200
Participants will receive intravesical TAR-200.
Cisplatin
Participants will receive cisplatin intravenously.
Gemcitabine
Participants will receive gemcitabine intravenously.
Conventional radiation therapy
Participants will receive conventional radiation therapy for bladder (64 gy).
Hypo-fractioned radiation therapy
Participants will receive hypo-fractioned radiation therapy for bladder (55 gy).
Locations (290)
Loma Linda Univ Faculty Medic
Loma Linda, California, United States
University of Southern California
Los Angeles, California, United States
Providence Saint John s Health Center
Santa Monica, California, United States
Stanford University Medical Center
Stanford, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
Foothills Urology - Golden Off
Golden, Colorado, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
Urological Research Network
Hialeah, Florida, United States
Memorial Healthcare System
Pembroke Pines, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
DuPage Medical Group
Lisle, Illinois, United States
University Hospitals Seidman Cancer Center
Ann Arbor, Michigan, United States
Michigan Institute of Urology
Troy, Michigan, United States
Adult Pediatric Urology & Urogynecology, P.C
Omaha, Nebraska, United States
Garden State Urology
Morristown, New Jersey, United States
New Jersey Urology LLC
Voorhees Township, New Jersey, United States
Cardiology Clinic at Montefiore Hutchinson Complex
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Vidant Urology - Greenville
Greenville, North Carolina, United States
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Wexner Medical Center at the Ohio State University
Columbus, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Houston Metro Urology
Houston, Texas, United States
University of Texas Medical Branch
League City, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Fundacion Intecnus
Bariloche, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Asociacion de Beneficencia Hospital Sirio Libanes
Buenos Aires, Argentina
Instituto Medico Especializado Alexander Fleming
Buenos Aires, Argentina
Centro de Urologia (CDU)
Ciudad Automoma Buenos Aires, Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, Argentina
Centro Urologico Profesor Bengio
Córdoba, Argentina
Sanatorio Allende Cerro
Córdoba, Argentina
Centro Oncologico Riojano Integral (Cori)
La Rioja, Argentina
Centro de Investigacion Pergamino SA
Pergamino, Argentina
CEDIC Centro de Investigaciones Clinicas
Viedma, Argentina
Flinders Medical Centre
Bedford Park, Australia
Krankenhaus der barmherzigen Schwestern
Linz, Austria
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, Austria
Medizinische Universitaet Wien
Vienna, Austria
Hopital Erasme
Anderlecht, Belgium
ZNA Middelheim
Antwerp, Belgium
AZ Sint-Lucas
Assebroek, Belgium
AZ Sint Jan Brugge Oostende AV
Bruges, Belgium
Az Groeninge
Kortrijk, Belgium
Algemeen Ziekenhuis Delta
Roeselare, Belgium
Fundacao Pio XII
Barretos, Brazil
Fundação Hospitalar São Francisco de Assis
Belo Horizonte, Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, Brazil
Centro Regional Integrado de Oncologia CRIO
Fortaleza, Brazil
Clinica de Oncologia Reichow
Jardim Blumenau, Brazil
Fundacao Doutor Amaral Carvalho
Jaú, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil
Hospital Regional do Cancer Hospital de Esperanca
Presidente Prudente, Brazil
Hospital Sao Rafael
Salvador, Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
São Paulo, Brazil
Sociedade Beneficente de Senhoras - Hospital Sirio Libanes
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Centro Oncológico do Triângulo
Uberlândia, Brazil
McGill University Health Centre
Montreal, Quebec, Canada
CHU de Quebec L Hotel Dieu de Quebec
Québec, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)
Beijing, China
Peking University First Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Beijing Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
The Third Xiangya Hospital of Central Sourth University
Changsha, China
Hunan Cancer hospital
Changsha Shi, China
West China Hospital of Sichuan University
Chengdu, China
Chongqing University Cancer Hospital
Chongqing, China
Sun Yat Sen University Cancer Center
Guangzhou, China
Guangzhou First Municipal People's Hospital
Guangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
The First Hospital of Jiaxing
Jiaxing, China
Nanjing Drum Tower Hospital
Nanjing, China
Qingdao Municipal Hospital
Qingdao, China
Ruijin Hospital
Shanghai, China
Renji Hospital
Shanghai, China
Shengjing Hospital Of China Medical University
Shenyang, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Wuhan Union Hospital
Wuhan, China
Wuhan Tongji Hospital Tongji Medical College
Wuhan, China
Yantai Yuhuangding Hospital
Yantai, China
Henan Cancer Hospital
Zhengzhou, China
Slezska nemocnice v Opave
Opava, Czechia
Fakultni nemocnice Plze
Plzen-Bory, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia