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ACTIVE NOT RECRUITING
NCT04658862
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Cetrelimab

Participants will receive intravenous Cetrelimab.

DRUG

TAR-200

Participants will receive intravesical TAR-200.

DRUG

Cisplatin

Participants will receive cisplatin intravenously.

DRUG

Gemcitabine

Participants will receive gemcitabine intravenously.

RADIATION

Conventional radiation therapy

Participants will receive conventional radiation therapy for bladder (64 gy).

RADIATION

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

And 190 more locations on ClinicalTrials.gov