A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

518

Participants

Timeline

Start Date

December 7, 2020

Primary Completion Date

December 30, 2026

Study Completion Date

December 31, 2028

Conditions
Urinary Bladder Neoplasms
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).

Trial Locations (290)

333

Chang Gung Memorial Hospital Linkou Branch, Taoyuan District

407

Taichung Veterans General Hospital, Taichung

807

Kaohsiung Medical University Chung Ho Memorial Hospital, Kaohsiung City

1062

Eszak Pesti Centrumkorhaz Honvedkorhaz, Budapest

1070

Hopital Erasme, Anderlecht

1090

Medizinische Universitaet Wien, Vienna

1106

Bajcsy-Zsilinszky Kórház és Rendelőintézet, Budapest

1122

Orszagos Onkologiai Intezet, Budapest

1307

Universitatsklinikum Carl Gustav Carus Dresden, Dresden

2020

ZNA Middelheim, Antwerp

4010

Krankenhaus der barmherzigen Schwestern, Linz

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4400

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza

4763

Hanyang University Hospital, Seoul

5000

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica, Córdoba

5020

Universitaetsklinikum Salzburg Landeskrankenhaus, Salzburg

5042

Flinders Medical Centre, Bedford Park

8000

AZ Sint Jan Brugge Oostende AV, Bruges

8035

Hosp Univ Vall D Hebron, Barcelona

8310

AZ Sint-Lucas, Assebroek

8400

Fundacion Intecnus, Bariloche

8500

Az Groeninge, Kortrijk

8800

Algemeen Ziekenhuis Delta, Roeselare

10048

National Taiwan University Hospital, Taipei

10060

Fondazione del Piemonte per I Oncologia IRCC Candiolo, Candiolo

10126

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino, Torino

10408

National Cancer Center, Goyang-si

10461

Cardiology Clinic at Montefiore Hutchinson Complex, The Bronx

11407

Hosp. de Jerez de La Frontera, Jerez de la Frontera

11490

Tri-Service General Hospital, Taipei

11528

Alexandra General Hospital of Athens, Athens

13009

Institut Paoli-Calmettes, Marseille

13698

Hôpital Européen, Marseille

14029

Chernihivskyi oblasnyi onkolohichnyi dyspanser, Chernihiv

14033

Hôpital Côte de Nacre, Caen

15006

Hosp Univ A Coruna, A Coruña

16100

SPDC Villa Scassi, Genova

16132

Ospedale San Martino, Genova

18014

Hosp. Univ. Virgen de Las Nieves, Granada

18547

Metropolitan Hospital, Neo Faliro

19004

MidLantic Urology, Bala-Cynwyd

20089

Istituto Clinico Humanitas Rozzano, IRCCS, Rozzano

20132

Ospedale San Raffaele, Milan

20141

Istituto Europeo di Oncologia, Milan

21100

Ospedale di Circolo e Fondazione Macchi, Varese

23502

Virginia Oncology Associates, Norfolk

27103

Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center, Winston-Salem

27584

Medical Park Gaziantep Hastanesi, Gaziantep

27710

Duke University Medical Center, Durham

27834

Vidant Urology - Greenville, Greenville

28027

Clinica Univ. de Navarra, Madrid

28041

Hosp. Univ. 12 de Octubre, Madrid

28046

Hosp. Univ. de La Paz, Madrid

28050

Hosp Univ Hm Sanchinarro, Madrid

29200

ICH Hopital A. Morvan, Brest

29572

Carolina Urologic Research Center, Myrtle Beach

30029

CHU Nimes, Nîmes

30322

Winship Cancer Institute of Emory University, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

31130

Clinical La Croix Du Sud - Ramsay Santé, Quint-Fonsegrives

33016

Urological Research Network, Hialeah

33028

Memorial Healthcare System, Pembroke Pines

33076

Hopital Pellegrin CHU Bordeaux, Bordeaux

33486

Boca Raton Regional Hospital, Boca Raton

34093

Bezmialem University Medical Faculty, Fatih

34096

Istanbul University Cerrahpasa Medical Faculty, Istanbul

34298

Institut Regional du Cancer de Montpellier, Montpellier

34732

Istanbul Medeniyet University Goztepe Training and Research Hospital, Istanbul

35128

Istituto Oncologico Veneto - IRCCS, Padua

35330

Dokuz Eylul Universitesi Tip Fakultesi, Balçova

35530

Izmir Medical Park Hospital, Izmir

35760

Centre Hospitalier Prive, Saint-Grégoire

36100

Ospedale San Bortolo, Vicenza

37000

Dr. Marco Antonio Badillo Santoyo, León

37170

Pole Sante Leonard de Vinci, Chambray-lès-Tours

37920

University of Tennessee Medical Center, Knoxville

38039

Erciyes Univ MKD Hospital, Melikgazi

38333

Anassa General Clinic, Volos

39008

Hosp. Univ. Marques de Valdecilla, Santander

40225

Universitatsklinikum Dusseldorf, Düesseldorf

40447

China Medical University Hospital, Taichung

41012

Ospedale Civile Ramazzini, Carpi

41404

Kyungpook National University Chilgok Hospital, Daegu

42270

Centre hospitalier universitaire de St Etienne, Saint-Etienne

42601

Keimyung University Dongsan Hospital, Daegu

43210

Wexner Medical Center at the Ohio State University, Columbus

44280

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

Inonu University Medical Faculty, Malatya

44625

Klinikum Herne - Urologie, Herne

45050

Consultorio Privado Dr Jose Arturo Rodriguez Rivera, Guadalajara

45070

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

45147

Klinik und Poliklinik für Urologie, Essen

46009

Instituto Valenciano de Oncologia, Valencia

46010

Hosp. Clinico Univ. de Valencia, Valencia

47179

Urologicum Duisburg, Duisburg

48022

Ospedale Umberto I di Lugo, Lugo

48084

Michigan Institute of Urology, Troy

48109

University Hospitals Seidman Cancer Center, Ann Arbor

48149

Universitatsklinikum Munster, Münster

49005

SE Dnipropetrovsk Medical Academy, Dnipro

50556

Uniwersytecki Szpital Kliniczny, Wroclaw

50612

Pusan National University Yangsan Hospital, Yangsan

52100

Ospedale San Donato, Arezzo

53100

Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte, Siena

54292

Krankenhaus der Barmherzigen Bruder Trier, Trier

54500

Institut de Cancerologie de Lorraine, Vandœuvre-lès-Nancy

54645

Euromedica General Clinic, Thessaloniki

55236

Clinic Agios Loukas, Thessaloniki

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

58128

Chonnam National University Hwasun Hospital, Hwasun-gun

58260

Centro de Investigacion Clinica Chapultepec, Morelia

59037

CHRU Lille, Lille

60431

Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus, Frankfurt am Main

60532

DuPage Medical Group, Lisle

60590

Universitatsklinikum Frankfurt, Frankfurt am Main

61070

Kharkiv Regional Clinical Hospital, Kharkiv

64710

i Can Oncology Center, Monterrey

68000

Oaxaca Site Management Organization S.C., Oaxaca City

68020

Centro de Investigacion Clinica de Oaxaca, Oaxaca City

68114

Adult Pediatric Urology & Urogynecology, P.C, Omaha

69437

Hôpital Edouard Herriot, Lyon

70000

Centro De Estudio Y Prevencion Del Cancer, Juchitán de Zaragoza

70403

National Cheng Kung University Hospital, Tainan City

71100

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, Foggia

73000

Khersonsky Regional Oncology Center, Kherson

73104

Stephenson Cancer Center, Oklahoma City

75014

Institut Mutualiste Montsouris, Paris

75015

Hopital Europeen Georges-Pompidou, Paris

75018

Hôpital Bichat - Claude Bernard, Paris

75020

Hopital Tenon, Paris

77027

Houston Metro Urology, Houston

77573

University of Texas Medical Branch, League City

78250

Oncologico Potosino, San Luis Potosí City

79000

Lviv Regional Clinical Hospital, Lviv

80078

ASL Napoli 2 Nord-SM delle Grazie Hospital, Pozzuoli

80131

Azienda Ospedaliera Universitaria Federico II, Napoli

80211

The Urology Center of Colorado, Denver

80401

Foothills Urology - Golden Off, Golden

83400

Clinique Sainte Marguerite, Hyères

84016

Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani, Pagani

86156

Klinikum Augsburg, Augsburg

87000

Polyclinique de Limoges - Francois Chenieux, Limoges

90033

University of Southern California, Los Angeles

90404

Providence Saint John s Health Center, Santa Monica

90419

Klinikum Nürnberg Nord - Hautklinik, Nuremberg

92150

Hopital Foch, Suresnes

92354

Loma Linda Univ Faculty Medic, Loma Linda

94305

Stanford University Medical Center, Stanford

94805

Gustave Roussy, Villejuif

95126

Ospedale Cannizzaro, Catania

100021

Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC), Beijing

100034

Peking University First Hospital, Beijing

100191

Peking University Third Hospital, Beijing

100730

Beijing Hospital, Beijing

110004

Shengjing Hospital Of China Medical University, Shenyang

110005

BLK Super Specialty Hospital, New Delhi

110075

Aakash Healthcare Super Speciality Hospital, New Delhi

110085

Rajiv Gandhi Cancer Institute & Research Centre, New Delhi

125284

Hertzen Oncology Research Institute, Moscow

130021

The First Hospital of Jilin University, Changchun

153040

Ivanovo Regional Oncology Dispensary, Ivanovo

197758

N.N. Petrov Research Institute Of Oncology, Saint Petersburg

200003

Ruijin Hospital, Shanghai

200020

Renji Hospital, Shanghai

210008

Nanjing Drum Tower Hospital, Nanjing

249031

A. Tsyb Medical Radiological Research Center, Obninsk

264000

Yantai Yuhuangding Hospital, Yantai

266011

Qingdao Municipal Hospital, Qingdao

300042

Tianjin Medical University Cancer Institute and Hospital, Tianjin

310014

Zhejiang Provincial People's Hospital, Hangzhou

314001

The First Hospital of Jiaxing, Jiaxing

325000

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

354057

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

390011

Ryazan State Medical University named after I.P.Pavlov, Ryazan

400030

Chongqing University Cancer Hospital, Chongqing

400601

Sujan Surgical Cancer Hospital & Amravati Cancer Foundation, Amravati

410013

The Third Xiangya Hospital of Central Sourth University, Changsha

Hunan Cancer hospital, Changsha Shi

411001

Jehangir Clinical Development Center Pvt Ltd, Pune

422005

Shatabdi Super Speciality Hospital, Nashik

430005

Ogarev Mordovian State University, Saransk

430023

Wuhan Union Hospital, Wuhan

430030

Wuhan Tongji Hospital Tongji Medical College, Wuhan

450008

Henan Cancer Hospital, Zhengzhou

Bashkir State Medical University, Ufa

510060

Sun Yat Sen University Cancer Center, Guangzhou

510180

Guangzhou First Municipal People's Hospital, Guangzhou

560002

Bangalore Medical College and Research Institute, Bangalore

610041

West China Hospital of Sichuan University, Chengdu

625041

Multifunctional clinical medical center 'Medical city', Tyumen

644013

BHI of Omsk region Clinical Oncology Dispensary, Omsk

656045

Altlay Regional Oncology Dispensary, Barnaul

660133

Krasnoyarsk Regional Oncology Dispensary, Krasnoyarsk

800014

Indira Gandhi Institute of Medical Sciences, Patna

3000075

Centro Hospitalar e Universitario de Coimbra, Coimbra

07960

Garden State Urology, Morristown

08043

New Jersey Urology LLC, Voorhees Township

C1199ABB

Hospital Italiano de Buenos Aires, Buenos Aires

C1419AHN

Asociacion de Beneficencia Hospital Sirio Libanes, Buenos Aires

C1426ANZ

Instituto Medico Especializado Alexander Fleming, Buenos Aires

C1120AAT

Centro de Urologia (CDU), Ciudad Automoma Buenos Aires

X5000KPH

Centro Urologico Profesor Bengio, Córdoba

X5004FHP

Sanatorio Allende Cerro, Córdoba

F5300COE

Centro Oncologico Riojano Integral (Cori), La Rioja

B2700CPM

Centro de Investigacion Pergamino SA, Pergamino

R8500EYO

CEDIC Centro de Investigaciones Clinicas, Viedma

14784-400

Fundacao Pio XII, Barretos

31110-580

Fundação Hospitalar São Francisco de Assis, Belo Horizonte

81520 060

Liga Paranaense de Combate ao Cancer, Curitiba

60336-232

Centro Regional Integrado de Oncologia CRIO, Fortaleza

89010 340

Clinica de Oncologia Reichow, Jardim Blumenau

17210 080

Fundacao Doutor Amaral Carvalho, Jaú

59062-000

Liga Norte Riograndense Contra O Cancer, Natal

90035 901

Associacao Hospitalar Moinhos de Vento, Porto Alegre

90035-903

Hospital das Clinicas de Porto Alegre, Porto Alegre

90610-000

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS, Porto Alegre

19013-050

Hospital Regional do Cancer - Hospital de Esperança, Presidente Prudente

41253 190

Hospital Sao Rafael, Salvador

09060 650

CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia, Santo André

15090-000

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base, São José do Rio Preto

01246 000

Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo, São Paulo

01327 001

Hospital Alemao Oswaldo Cruz, São Paulo

01509 900

Fundacao Antonio Prudente A C Camargo Cancer Center, São Paulo

04039-004

Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE, São Paulo

04784180

Sociedade Beneficente de Senhoras - Hospital Sirio Libanes, São Paulo

05652 900

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein, São Paulo

38408-150

Centro Oncológico do Triângulo, Uberlândia

H4A 3J1

McGill University Health Centre, Montreal

G1R 2J6

CHU de Quebec L Hotel Dieu de Quebec, Québec

J1H 5H3

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke

746 01

Slezska nemocnice v Opave, Opava

305 99

Fakultni nemocnice Plze, Plzen-Bory

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

120 00

Urocentrum Praha, Prague

128 08

Vseobecna fakultni nemocnice v Praze, Prague

140 59

Thomayerova nemocnice, Prague

150 06

Fakultni nemocnice v Motole, Prague

180 81

Nemocnice Na Bulovce, Prague

38126 DE

Staedtisches Klinikum Braunschweig, Braunschweig

D-74078

SLK-Kliniken Heilbronn - Klinikum am Gesundbrunnen, Heilbronn

04416

Matthias Schulze - Germany, Markkleeberg

155 62

Metropolitan General A E, Cholargós

151 25

Athens Medical Center, Marousi

546 22

Interbalkan Medical Center of Thessaloniki, Thessaloniki

TK 56403

Papageorgiou General Hospital Of Thessaloniki, Thessaloniki

334 003

Acharya Tulsi Regional Cancer Treatment Research Institute, Bikaner

00168

Policlinico Universitario Agostino Gemelli, Roma

00189

Azienda Ospedaliera Sant Andrea, Roma

00128

Universita Campus Bio-Medico di Roma, Rome

00144

Istituto Nazionale Tumori Regina Elena, Rome

820-8501

Aso Co.,Ltd Iizuka Hospital, Iizuka

216 8511

St Marianna University Hospital, Kanagawa

634-8522

Nara Medical University Hospital, Kashihara

350-8550

Saitama Medical University Hospital, Kawagoe-Shi

292-8535

Kimitsu Chuo Hospital, Kisarazu-shi

852-8501

Nagasaki University Hospital, Nagasaki

591-8025

JOHAS Osaka Rosai Hospital, Osaka

745-8522

Tokuyama Central Hospital, Shūnan

105-8470

Toranomon Hospital, Tokyo

113 8603

Nippon Medical School Hospital, Tokyo

470-1192

Fujita Health University Hospital, Toyoake

755-8505

Yamaguchi University Hospital, Ube

232 0024

Yokohama City University Medical Center, Yokohama

06720

Oncologia Integral Satelite, Mexico City

08-110

Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II, Siedlce

60 185

Centrum Medyczne Pratia Poznan, Skorzewo

02-507

Centralny Szpital Kliniczny MSWiA w Warszawie, Warsaw

2805-267

Hospital Garcia de Orta, Almada

1150-199

Centro Hospitalar de Lisboa Central, Lisbon

1400-038

Fund. Champalimaud, Lisbon

1649-035

H. Santa Maria - Centro Hospitalar de Lisboa Norte, Lisbon

4200-319

Hospital de Sao Joao, Porto

612-896

Inje University Haeundae Paik Hospital, Busan

06351

Samsung Medical Center, Gangnam Gu

405 760

Gachon University Gil Medical Center, Namdong

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Seoul

06273

Gangnam Severance Hospital, Seoul

06591

The Catholic University of Korea Seoul St Mary s Hospital, Seoul

08916

Hosp. Univ. Germans Trias I Pujol, Badalona

08025

Fund. Puigvert, Barcelona

08208

Corporacio Sanitari Parc Tauli, Sabadell

Unknown

Adana Baskent Yuregir Hospital, Adana

06050

Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital, Ankara

06100

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi, Ankara

01330

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

08173

Asklepion LLC, Kiev

02660

Kyiv City Clinical Hospital #3, Kyiv

04053

State Institution Academy Of Medical Sciences Of Ukraine, Kyiv

04112

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

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY