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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

2026-03-19

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

Associacao Hospitalar Moinhos de Vento

Porto Alegre, Brazil

Hospital das Clinicas de Porto Alegre

Porto Alegre, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

Hospital Regional do Cancer - Hospital de Esperança

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

Urocentrum Praha

Prague, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Thomayerova nemocnice

Prague, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

Nemocnice Na Bulovce

Prague, Czechia

Hopital Pellegrin CHU Bordeaux

Bordeaux, France

ICH Hopital A. Morvan

Brest, France

Hopital Cote de Nacre 1

Caen, France

Pole Sante Leonard de Vinci

Chambray-lès-Tours, France

Clinique Sainte Marguerite

Hyères, France

CHRU Lille

Lille, France

Polyclinique de Limoges - Francois Chenieux

Limoges, France

Hôpital Edouard Herriot

Lyon, France

Institut Paoli-Calmettes

Marseille, France

Hôpital Européen

Marseille, France

Institut Regional du Cancer de Montpellier

Montpellier, France

CHU Nimes

Nîmes, France

Institut Mutualiste Montsouris

Paris, France

Hopital Europeen Georges-Pompidou

Paris, France

Hôpital Bichat - Claude Bernard

Paris, France

Hopital Tenon

Paris, France

Clinical La Croix Du Sud - Ramsay Santé

Quint-Fonsegrives, France

Centre hospitalier universitaire de St Etienne

Saint-Etienne, France

Centre Hospitalier Prive

Saint-Grégoire, France

Hopital Foch

Suresnes, France

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

Gustave Roussy

Villejuif, France

Klinikum Augsburg

Augsburg, Germany

Staedtisches Klinikum Braunschweig

Braunschweig, Germany

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Urologicum Duisburg

Duisburg, Germany

Universitatsklinikum Dusseldorf

Düesseldorf, Germany

Klinik und Poliklinik für Urologie

Essen, Germany

Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

Frankfurt am Main, Germany

Universitatsklinikum Frankfurt

Frankfurt am Main, Germany

Medizinische Hochschule Hannover

Hanover, Germany

SLK-Kliniken Heilbronn - Klinikum am Gesundbrunnen

Heilbronn, Germany

Klinikum Herne - Urologie

Herne, Germany

Matthias Schulze - Germany

Markkleeberg, Germany

Universitatsklinikum Munster

Münster, Germany

Klinikum Nürnberg Nord - Hautklinik

Nuremberg, Germany

Krankenhaus der Barmherzigen Bruder Trier

Trier, Germany

Alexandra General Hospital of Athens

Athens, Greece

Metropolitan General A E

Cholargós, Greece

Athens Medical Center

Marousi, Greece

Metropolitan Hospital

Neo Faliro, Greece

Interbalkan Medical Center of Thessaloniki

Thessaloniki, Greece

Euromedica General Clinic

Thessaloniki, Greece

Clinic Agios Loukas

Thessaloniki, Greece

Papageorgiou General Hospital Of Thessaloniki

Thessaloniki, Greece

Anassa General Clinic

Volos, Greece

Eszak Pesti Centrumkorhaz Honvedkorhaz

Budapest, Hungary

Bajcsy-Zsilinszky Kórház és Rendelőintézet

Budapest, Hungary

Orszagos Onkologiai Intezet

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, Hungary

Sujan Surgical Cancer Hospital & Amravati Cancer Foundation

Amravati, India

Bangalore Medical College and Research Institute

Bangalore, India

Acharya Tulsi Regional Cancer Treatment Research Institute

Bikaner, India

Shatabdi Super Speciality Hospital

Nashik, India

BLK Super Specialty Hospital

New Delhi, India

Aakash Healthcare Super Speciality Hospital

New Delhi, India

Rajiv Gandhi Cancer Institute & Research Centre

New Delhi, India

Indira Gandhi Institute of Medical Sciences

Patna, India

Jehangir Clinical Development Center Pvt Ltd

Pune, India

Ospedale San Donato

Arezzo, Italy

Fondazione del Piemonte per I Oncologia IRCC Candiolo

Candiolo, Italy

Ospedale Civile Ramazzini

Carpi, Italy

Ospedale Cannizzaro

Catania, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

Foggia, Italy

SPDC Villa Scassi

Genova, Italy

Ospedale San Martino

Genova, Italy

Ospedale Umberto I di Lugo

Lugo, Italy

Ospedale San Raffaele

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

Istituto Oncologico Veneto - IRCCS 1

Padova, Italy

Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani

Pagani, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

ASL Napoli 2 Nord-SM delle Grazie Hospital

Pozzuoli, Italy

Policlinico Universitario Agostino Gemelli

Roma, Italy

Azienda Ospedaliera Sant Andrea

Roma, Italy

Universita Campus Bio-Medico di Roma

Rome, Italy

Istituto Nazionale Tumori Regina Elena

Rome, Italy

Istituto Clinico Humanitas Rozzano, IRCCS

Rozzano, Italy

Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte

Siena, Italy

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Torino, Italy

Ospedale di Circolo e Fondazione Macchi

Varese, Italy

Ospedale San Bortolo

Vicenza, Italy

Aso Co.,Ltd Iizuka Hospital

Iizuka, Japan

St Marianna University Hospital

Kanagawa, Japan

Nara Medical University Hospital

Kashihara, Japan

Saitama Medical University Hospital

Kawagoe-Shi, Japan

Kimitsu Chuo Hospital

Kisarazu-shi, Japan

Nagasaki University Hospital

Nagasaki, Japan

JOHAS Osaka Rosai Hospital

Osaka, Japan

Tokuyama Central Hospital

Shūnan, Japan

Toranomon Hospital

Tokyo, Japan

Nippon Medical School Hospital

Tokyo, Japan

Fujita Health University Hospital

Toyoake, Japan

Yamaguchi University Hospital

Ube, Japan

Yokohama City University Medical Center

Yokohama, Japan

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Mexico

Consultorio Privado Dr Jose Arturo Rodriguez Rivera

Guadalajara, Mexico

Centro De Estudio Y Prevencion Del Cancer

Juchitán de Zaragoza, Mexico

Dr. Marco Antonio Badillo Santoyo

León, Mexico

Oncologia Integral Satelite

Mexico City, Mexico

i Can Oncology Center

Monterrey, Mexico

Centro de Investigacion Clinica Chapultepec

Morelia, Mexico

Oaxaca Site Management Organization S.C.

Oaxaca City, Mexico

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, Mexico

Oncologico Potosino

San Luis Potosí City, Mexico

Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V.

Zapopan, Mexico

Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

Siedlce, Poland

Centrum Medyczne Pratia Poznan

Skorzewo, Poland

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, Poland

Uniwersytecki Szpital Kliniczny

Wroclaw, Poland

Hospital Garcia de Orta

Almada, Portugal

Centro Hospitalar e Universitario de Coimbra

Coimbra, Portugal

Centro Hospitalar de Lisboa Central

Lisbon, Portugal

Fund. Champalimaud

Lisbon, Portugal

H. Santa Maria - Centro Hospitalar de Lisboa Norte

Lisbon, Portugal

Hospital de Sao Joao

Porto, Portugal

Altlay Regional Oncology Dispensary

Barnaul, Russia

Ivanovo Regional Oncology Dispensary

Ivanovo, Russia

Krasnoyarsk Regional Oncology Dispensary

Krasnoyarsk, Russia

Hertzen Oncology Research Institute

Moscow, Russia

A. Tsyb Medical Radiological Research Center

Obninsk, Russia

BHI of Omsk region Clinical Oncology Dispensary

Omsk, Russia

Ryazan State Medical University named after I.P.Pavlov

Ryazan, Russia

N.N. Petrov Research Institute Of Oncology

Saint Petersburg, Russia

Ogarev Mordovian State University

Saransk, Russia

State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio

Sochi, Russia

Multifunctional clinical medical center 'Medical city'

Tyumen, Russia

Bashkir State Medical University

Ufa, Russia

Inje University Haeundae Paik Hospital

Busan, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

Samsung Medical Center

Gangnam Gu, South Korea

National Cancer Center

Goyang-si, South Korea

Chonnam National University Hwasun Hospital

Hwasun-gun, South Korea

Gachon University Gil Medical Center

Namdong, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, South Korea

Hanyang University Hospital

Seoul, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea

Hosp Univ A Coruna

A Coruña, Spain

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain

Fund. Puigvert

Barcelona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp. Univ. Virgen de Las Nieves

Granada, Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, Spain

Clinica Univ. de Navarra

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Univ. de La Paz

Madrid, Spain

Hosp Univ Hm Sanchinarro

Madrid, Spain

Corporacio Sanitari Parc Tauli

Sabadell, Spain

Hosp. Univ. Marques de Valdecilla

Santander, Spain

Instituto Valenciano de Oncologia

Valencia, Spain

Hosp. Clinico Univ. de Valencia

Valencia, Spain

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital Linkou Branch

Taoyuan District, Taiwan

Adana Baskent Yuregir Hospital

Adana, Turkey (Türkiye)

Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital

Ankara, Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

Ankara, Turkey (Türkiye)

Dokuz Eylul Universitesi Tip Fakultesi

Balçova, Turkey (Türkiye)

Bezmialem University Medical Faculty

Fatih, Turkey (Türkiye)

Medical Park Gaziantep Hastanesi

Gaziantep, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Istanbul Medeniyet University Goztepe Training and Research Hospital

Istanbul, Turkey (Türkiye)

Izmir Medical Park Hospital

Izmir, Turkey (Türkiye)

Inonu University Medical Faculty

Malatya, Turkey (Türkiye)

Erciyes Univ MKD Hospital

Melikgazi, Turkey (Türkiye)

T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma Hastanesi

Seyhan, Turkey (Türkiye)

Chernihivskyi oblasnyi onkolohichnyi dyspanser

Chernihiv, Ukraine

SE Dnipropetrovsk Medical Academy

Dnipro, Ukraine

Kharkiv Regional Clinical Hospital

Kharkiv, Ukraine

Khersonsky Regional Oncology Center

Kherson, Ukraine

Asklepion LLC

Kiev, Ukraine

Kyiv City Clinical Hospital #3

Kyiv, Ukraine

State Institution Academy Of Medical Sciences Of Ukraine

Kyiv, Ukraine

P.L. Shupyk National Medical Academy of Post-Graduate Education

Kyiv, Ukraine

Lviv Regional Clinical Hospital

Lviv, Ukraine