A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder (SunRISe-2)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Bladder Neoplasms
• Intervention / Treatment: Biological: Cetrelimab; Drug: TAR-200; Drug: Cisplatin; Drug: Gemcitabine; Radiation: Conventional radiation therapy; Radiation: Hypo-fractioned radiation therapy

Detailed Description

The TAR-200 is an investigational intravesical drug delivery system. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed cell death protein 1 (PD-1). Study consists of screening phase of 42 days, treatment phase and follow up phase. The total duration of study will be up to 8 years. Efficacy evaluation includes disease assessment (Cystoscopy/TURBT Biopsy/Pathology) and Patient Reported Outcomes (Quality of Life Assessments) and safety assessments includes vital sign measurements, 12-lead electrocardiogram (ECG), physical examinations, clinical laboratory tests, cystoscopic examination, anti-drug antibody (ADA) assessments, concomitant treatments/procedures and adverse event monitoring.

• Study Type: Interventional
• Enrollment (Actual): 518
• Phase: Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Bariloche, Argentina, 8400
    • Fundacion INTECNUS
  • Buenos Aires, Argentina, C1426ANZ
    • Instituto Medico Especializado Alexander Fleming
  • Buenos Aires, Argentina, C1419AHN
    • Asociación de Beneficencia Hospital Sirio Libanés
  • Buenos Aires, Argentina, C1199ABB
    • Hospital Italiano de Buenos Aires
  • Ciudad Automoma Buenos Aires, Argentina, C1120AAT
    • Centro de Urología (CDU)
  • Córdoba, Argentina, 5000
    • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • Córdoba, Argentina, X5000KPH
    • Centro Urologico Profesor Bengio
  • Córdoba, Argentina, X5004FHP
    • Sanatorio Allende Cerro
  • La Rioja, Argentina, F5300COE
    • Centro Oncologico Riojano Integral (CORI)
  • Pergamino, Argentina, B2700CPM
    • Centro de Investigacion Pergamino SA
  • Viedma, Argentina, R8500EYO
    • CEDIC Centro de Investigaciones Clinicas
• Australia
  • Bedford Park, Australia, 5042
    • Flinders Medical Centre
• Austria
  • Linz, Austria, 4010
    • Krankenhaus der barmherzigen Schwestern
  • Salzburg, Austria, 5020
    • Universitaetsklinikum Salzburg Landeskrankenhaus
  • Vienna, Austria, 1090
    • Medizinische Universitaet Wien
• Belgium
  • Anderlecht, Belgium, 1070
    • Hôpital Erasme
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Assebroek, Belgium, 8310
    • AZ Sint-Lucas
  • Bruges, Belgium, 8000
    • AZ Sint Jan Brugge Oostende AV
  • Kortrijk, Belgium, 8500
    • AZ Groeninge
  • Roeselare, Belgium, 8800
    • Algemeen Ziekenhuis Delta
• Brazil
  • Barretos, Brazil, 14784-400
    • Fundação Pio XII
  • Belo Horizonte, Brazil, 31110-580
    • Fundação Hospitalar São Francisco de Assis
  • Curitiba, Brazil, 81520 060
    • Liga Paranaense de Combate ao Cancer
  • Fortaleza, Brazil, 60336-232
    • Centro Regional Integrado de Oncologia CRIO
  • Jardim Blumenau, Brazil, 89010 340
    • Clínica de Oncologia Reichow
  • Jaú, Brazil, 17210 080
    • Fundação Doutor Amaral Carvalho
  • Natal, Brazil, 59062-000
    • Liga Norte Riograndense Contra o Câncer
  • Porto Alegre, Brazil, 90035-903
    • Hospital das Clinicas de Porto Alegre
  • Porto Alegre, Brazil, 90610-000
    • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
  • Porto Alegre, Brazil, 90035 901
    • Associação Hospitalar Moinhos de Vento
  • Presidente Prudente, Brazil, 19013-050
    • Hospital Regional do Cancer - Hospital de Esperança
  • Salvador, Brazil, 41253 190
    • Hospital Sao Rafael
  • Santo André, Brazil, 09060 650
    • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
  • São José do Rio Preto, Brazil, 15090-000
    • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
  • São Paulo, Brazil, 01509 900
    • Fundacao Antonio Prudente A C Camargo Cancer Center
  • São Paulo, Brazil, 04039-004
    • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
  • São Paulo, Brazil, 01246 000
    • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
  • São Paulo, Brazil, 05652 900
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 01327 001
    • Hospital Alemao Oswaldo Cruz
  • São Paulo, Brazil, 04784180
    • Sociedade Beneficente de Senhoras - Hospital Sirio Libanes
  • Uberlândia, Brazil, 38408-150
    • Centro Oncológico do Triângulo
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre
    • Québec, Quebec, Canada, G1R 2J6
      • CHU de Quebec L Hotel Dieu de Quebec
    • Sherbrooke, Quebec, Canada, J1H 5H3
      • Centre Hospitalier Universitaire de Sherbrooke
• China
  • Beijing, China, 100730
    • Beijing Hospital
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100021
    • Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changsha, China, 410013
    • The Third Xiangya Hospital of Central Sourth University
  • Changsha Shi, China, 410013
    • Hunan Cancer Hospital
  • Chengdu, China, 610041
    • West China Hospital of Sichuan University
  • Chongqing, China, 400030
    • Chongqing University Cancer Hospital
  • Guangzhou, China, 510180
    • Guangzhou First Municipal People's Hospital
  • Guangzhou, China, 510060
    • Sun Yat Sen University Cancer Center
  • Hangzhou, China, 310014
    • Zhejiang Provincial People's Hospital
  • Jiaxing, China, 314001
    • The First Hospital of Jiaxing
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Qingdao, China, 266011
    • Qingdao Municipal Hospital
  • Shanghai, China, 200003
    • Ruijin Hospital
  • Shanghai, China, 200020
    • RenJi Hospital
  • Shenyang, China, 110004
    • Shengjing Hospital of China Medical University
  • Tianjin, China, 300042
    • Tianjin Medical University Cancer Institute and Hospital
  • Wenzhou, China, 325000
    • The First Affiliated Hospital of Wenzhou Medical University
  • Wuhan, China, 430023
    • Wuhan Union Hospital
  • Wuhan, China, 430030
    • Wuhan Tongji Hospital Tongji Medical College
  • Yantai, China, 264000
    • Yantai Yuhuangding Hospital
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
• Czechia
  • Opava, Czechia, 746 01
    • Slezska nemocnice v Opave
  • Plzen-Bory, Czechia, 305 99
    • Fakultni nemocnice Plze
  • Prague, Czechia, 128 08
    • Vseobecna Fakultni Nemocnice V Praze
  • Prague, Czechia, 100 34
    • Fakultní Nemocnice Královské Vinohrady
  • Prague, Czechia, 140 59
    • Thomayerova nemocnice
  • Prague, Czechia, 150 06
    • Fakultni nemocnice v Motole
  • Prague, Czechia, 120 00
    • Urocentrum Praha
  • Prague, Czechia, 180 81
    • Nemocnice Na Bulovce
• France
  • Bordeaux, France, 33076
    • Hopital Pellegrin CHU Bordeaux
  • Brest, France, 29200
    • ICH Hopital A. Morvan
  • Caen, France, 14033
    • Hopital Cote de Nacre 1
  • Chambray-lès-Tours, France, 37170
    • Pôle Santé Léonard De Vinci
  • Hyères, France, 83400
    • Clinique Sainte Marguerite
  • Lille, France, 59037
    • CHRU Lille
  • Limoges, France, 87000
    • Polyclinique de Limoges - Francois Chenieux
  • Lyon, France, 69437
    • Hopital Edouard Herriot
  • Marseille, France, 13009
    • Institut Paoli-Calmettes
  • Marseille, France, 13698
    • Hopital Europeen
  • Montpellier, France, 34298
    • Institut régional du Cancer de Montpellier
  • Nîmes, France, 30029
    • CHU Nîmes
  • Paris, France, 75018
    • Hôpital Bichat - Claude Bernard
  • Paris, France, 75014
    • Institut Mutualiste Montsouris
  • Paris, France, 75015
    • Hôpital Européen Georges-Pompidou
  • Paris, France, 75020
    • Hopital Tenon
  • Quint-Fonsegrives, France, 31130
    • Clinical La Croix Du Sud - Ramsay Santé
  • Saint-Etienne, France, 42270
    • Centre hospitalier universitaire de St Etienne
  • Saint-Grégoire, France, 35760
    • Centre Hospitalier Prive
  • Suresnes, France, 92150
    • Hopital Foch
  • Vandœuvre-lès-Nancy, France, 54500
    • Institut de Cancerologie de Lorraine
  • Villejuif, France, 94805
    • Gustave Roussy
• Germany
  • Augsburg, Germany, 86156
    • Klinikum Augsburg
  • Braunschweig, Germany, 38126 DE
    • Staedtisches Klinikum Braunschweig
  • Dresden, Germany, 1307
    • Universitätsklinikum Carl Gustav Carus Dresden
  • Duisburg, Germany, 47179
    • Urologicum Duisburg
  • Düesseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf
  • Essen, Germany, 45147
    • Klinik und Poliklinik für Urologie
  • Frankfurt am Main, Germany, 60590
    • Universitätsklinikum Frankfurt
  • Frankfurt am Main, Germany, 60431
    • Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Heilbronn, Germany, D-74078
    • SLK-Kliniken Heilbronn - Klinikum am Gesundbrunnen
  • Herne, Germany, 44625
    • Klinikum Herne - Urologie
  • Markkleeberg, Germany, 04416
    • Matthias Schulze - Germany
  • Münster, Germany, 48149
    • Universitatsklinikum Munster
  • Nuremberg, Germany, 90419
    • Klinikum Nürnberg Nord - Hautklinik
  • Trier, Germany, 54292
    • Krankenhaus der Barmherzigen Brüder Trier
• Greece
  • Athens, Greece, 11528
    • Alexandra General Hospital of Athens
  • Cholargós, Greece, 155 62
    • Metropolitan General A E
  • Marousi, Greece, 151 25
    • Athens Medical Center
  • Neo Faliro, Greece, 18547
    • Metropolitan Hospital
  • Thessaloniki, Greece, 54645
    • Euromedica General Clinic
  • Thessaloniki, Greece, TK 56403
    • Papageorgiou General Hospital of Thessaloniki
  • Thessaloniki, Greece, 55236
    • Clinic Agios Loukas
  • Thessaloniki, Greece, 546 22
    • Interbalkan Medical Center of Thessaloniki
  • Volos, Greece, 38333
    • Anassa General Clinic
• Hungary
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet
  • Budapest, Hungary, 1106
    • Bajcsy-Zsilinszky Korhaz es Rendelointezet
  • Budapest, Hungary, 1062
    • Eszak Pesti Centrumkorhaz Honvedkorhaz
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Nyíregyháza, Hungary, 4400
    • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
• India
  • Amravati, India, 400601
    • Sujan Surgical Cancer Hospital & Amravati Cancer Foundation
  • Bangalore, India, 560002
    • Bangalore Medical College and Research Institute
  • Bikaner, India, 334 003
    • Acharya Tulsi Regional Cancer Treatment Research Institute
  • Nashik, India, 422005
    • Shatabdi Super Speciality Hospital
  • New Delhi, India, 110075
    • Aakash Healthcare Super Speciality Hospital
  • New Delhi, India, 110085
    • Rajiv Gandhi Cancer Institute & Research Centre
  • New Delhi, India, 110005
    • BLK Super Specialty Hospital
  • Patna, India, 800014
    • Indira Gandhi Institute of Medical Sciences
  • Pune, India, 411001
    • Jehangir Clinical Development Center Pvt Ltd
• Italy
  • Arezzo, Italy, 52100
    • Ospedale San Donato
  • Candiolo, Italy, 10060
    • Fondazione del Piemonte per I Oncologia IRCC Candiolo
  • Carpi, Italy, 41012
    • Ospedale Civile Ramazzini
  • Catania, Italy, 95126
    • Ospedale Cannizzaro
  • Foggia, Italy, 71100
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
  • Genova, Italy, 16132
    • Ospedale San Martino
  • Genova, Italy, 16100
    • SPDC Villa Scassi
  • Lugo, Italy, 48022
    • Ospedale Umberto I di Lugo
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia
  • Naples, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto - IRCCS 1
  • Pagani, Italy, 84016
    • Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana
  • Pozzuoli, Italy, 80078
    • ASL Napoli 2 Nord-SM delle Grazie Hospital
  • Roma, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
  • Roma, Italy, 00189
    • Azienda Ospedaliera Sant Andrea
  • Rome, Italy, 00128
    • Università Campus Bio-Medico di Roma
  • Rome, Italy, 00144
    • Istituto Nazionale Tumori Regina Elena
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas Rozzano, IRCCS
  • Siena, Italy, 53100
    • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
  • Torino, Italy, 10126
    • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
  • Varese, Italy, 21100
    • Ospedale di Circolo e Fondazione Macchi
  • Vicenza, Italy, 36100
    • Ospedale San Bortolo
• Japan
  • Iizuka, Japan, 820-8501
    • Aso Co.,Ltd Iizuka Hospital
  • Kanagawa, Japan, 216 8511
    • St Marianna University Hospital
  • Kashihara, Japan, 634-8522
    • Nara Medical University Hospital
  • Kawagoe-Shi, Japan, 350-8550
    • Saitama Medical University Hospital
  • Kisarazu-shi, Japan, 292-8535
    • Kimitsu Chuo Hospital
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital
  • Osaka, Japan, 591-8025
    • JOHAS Osaka Rosai Hospital
  • Shūnan, Japan, 745-8522
    • Tokuyama Central Hospital
  • Tokyo, Japan, 105-8470
    • Toranomon Hospital
  • Tokyo, Japan, 113 8603
    • Nippon Medical School Hospital
  • Toyoake, Japan, 470-1192
    • Fujita Health University Hospital
  • Ube, Japan, 755-8505
    • Yamaguchi University Hospital
  • Yokohama, Japan, 232 0024
    • Yokohama City University Medical Center
• Mexico
  • Guadalajara, Mexico, 44280
    • Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Guadalajara, Mexico, 45050
    • Consultorio Privado Dr Jose Arturo Rodriguez Rivera
  • Juchitán de Zaragoza, Mexico, 70000
    • Centro De Estudio Y Prevencion Del Cancer
  • León, Mexico, 37000
    • Dr. Marco Antonio Badillo Santoyo
  • Mexico City, Mexico, 06720
    • Oncología Integral Satélite
  • Monterrey, Mexico, 64710
    • I Can Oncology Center
  • Morelia, Mexico, 58260
    • Centro de Investigación Clinica Chapultepec
  • Oaxaca City, Mexico, 68000
    • Oaxaca Site Management Organization S.C.
  • Oaxaca City, Mexico, 68020
    • Centro de Investigacion Clinica de Oaxaca
  • San Luis Potosí City, Mexico, 78209
    • Oncologico Potosino
  • Zapopan, Mexico, 45070
    • Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V.
• Poland
  • Siedlce, Poland, 08-110
    • Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
  • Skorzewo, Poland, 60 185
    • Centrum Medyczne Pratia Poznań
  • Warsaw, Poland, 02-507
    • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Wroclaw, Poland, 50556
    • Uniwersytecki Szpital Kliniczny
• Portugal
  • Almada, Portugal, 2805-267
    • Hospital Garcia de Orta
  • Coimbra, Portugal, 3000075
    • Centro Hospitalar E Universitário De Coimbra
  • Lisbon, Portugal, 1400-038
    • Fund. Champalimaud
  • Lisbon, Portugal, 1649-035
    • H. Santa Maria - Centro Hospitalar de Lisboa Norte
  • Lisbon, Portugal, 1150-199
    • Centro Hospitalar de Lisboa Central
  • Porto, Portugal, 4200-319
    • Hospital de Sao Joao
• Russia
  • Barnaul, Russia, 656045
    • Altlay Regional Oncology Dispensary
  • Ivanovo, Russia, 153040
    • Ivanovo regional oncology dispensary
  • Krasnoyarsk, Russia, 660133
    • Krasnoyarsk Regional Oncology Dispensary
  • Moscow, Russia, 125284
    • Hertzen Oncology Research Institute
  • Obninsk, Russia, 249031
    • A. Tsyb Medical Radiological Research Center
  • Omsk, Russia, 644013
    • BHI of Omsk region Clinical Oncology Dispensary
  • Ryazan, Russia, 390011
    • Ryazan State Medical University named after I.P.Pavlov
  • Saint Petersburg, Russia, 197758
    • N.N. Petrov Research Institute Of Oncology
  • Saransk, Russia, 430005
    • Ogarev Mordovian State University
  • Sochi, Russia, 354057
    • State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio
  • Tyumen, Russia, 625041
    • Multifunctional clinical medical center 'Medical city'
  • Ufa, Russia, 450008
    • Bashkir State Medical University
• South Korea
  • Busan, South Korea, 612-896
    • Inje University Haeundae Paik Hospital
  • Daegu, South Korea, 42601
    • Keimyung University Dongsan Hospital
  • Daegu, South Korea, 41404
    • Kyungpook National University Chilgok Hospital
  • Gangnam Gu, South Korea, 06351
    • Samsung Medical Center
  • Goyang-si, South Korea, 10408
    • National Cancer Center
  • Hwasun-gun, South Korea, 58128
    • Chonnam National University Hwasun Hospital
  • Namdong, South Korea, 405 760
    • Gachon University Gil Medical Center
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital
  • Seoul, South Korea, 06273
    • Gangnam Severance Hospital
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Mary s Hospital
  • Seoul, South Korea, 4763
    • Hanyang University Hospital
  • Yangsan, South Korea, 50612
    • Pusan National University Yangsan Hospital
• Spain
  • A Coruña, Spain, 15006
    • Hosp Univ A Coruna
  • Badalona, Spain, 08916
    • Hosp. Univ. Germans Trias I Pujol
  • Barcelona, Spain, 08025
    • Fund. Puigvert
  • Barcelona, Spain, 8035
    • Hosp Univ Vall D Hebron
  • Granada, Spain, 18014
    • Hosp. Univ. Virgen de Las Nieves
  • Jerez de la Frontera, Spain, 11407
    • Hosp. de Jerez de La Frontera
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28027
    • Clinica Univ. de Navarra
  • Madrid, Spain, 28046
    • Hosp. Univ. de La Paz
  • Madrid, Spain, 28050
    • Hosp Univ Hm Sanchinarro
  • Sabadell, Spain, 08208
    • Corporacio Sanitari Parc Tauli
  • Santander, Spain, 39008
    • Hosp. Univ. Marques de Valdecilla
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia
  • Valencia, Spain, 46010
    • Hosp. Clinico Univ. de Valencia
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung Ho Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11490
    • Tri-Service General Hospital
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital Linkou Branch
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye)
    • Adana Baskent Yuregir Hospital
  • Ankara, Turkey (Türkiye), 06050
    • Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital
  • Ankara, Turkey (Türkiye), 06100
    • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
  • Balçova, Turkey (Türkiye), 35330
    • Dokuz Eylul Universitesi Tip Fakultesi
  • Fatih, Turkey (Türkiye), 34093
    • Bezmialem University Medical Faculty
  • Gaziantep, Turkey (Türkiye), 27584
    • Medical Park Gaziantep Hastanesi
  • Istanbul, Turkey (Türkiye), 34096
    • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul, Turkey (Türkiye), 34732
    • Istanbul Medeniyet University Goztepe Training and Research Hospital
  • Izmir, Turkey (Türkiye), 35530
    • Izmir Medical Park Hospital
  • Malatya, Turkey (Türkiye), 44280
    • Inonu University Medical Faculty
  • Melikgazi, Turkey (Türkiye), 38039
    • Erciyes Univ MKD Hospital
  • Seyhan, Turkey (Türkiye), 01330
    • T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma Hastanesi
• Ukraine
  • Chernihiv, Ukraine, 14029
    • Chernihivskyi oblasnyi onkolohichnyi dyspanser
  • Dnipro, Ukraine, 49005
    • SE Dnipropetrovsk Medical Academy
  • Kharkiv, Ukraine, 61070
    • Kharkiv Regional Clinical Hospital
  • Kherson, Ukraine, 73000
    • Khersonsky Regional Oncology Center
  • Kiev, Ukraine, 08173
    • Asklepion LLC
  • Kyiv, Ukraine, 02660
    • Kyiv City Clinical Hospital #3
  • Kyiv, Ukraine, 04053
    • State Institution Academy Of Medical Sciences Of Ukraine
  • Kyiv, Ukraine, 04112
    • P.L. Shupyk National Medical Academy of Post-Graduate Education
  • Lviv, Ukraine, 79000
    • Lviv Regional Clinical Hospital
• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda Univ Faculty Medic
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Santa Monica, California, United States, 90404
      • Providence Saint John s Health Center
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Colorado
    • Denver, Colorado, United States, 80211
      • The Urology Center of Colorado
    • Golden, Colorado, United States, 80401
      • Foothills Urology - Golden Off
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital
    • Hialeah, Florida, United States, 33016
      • Urological Research Network
    • Pembroke Pines, Florida, United States, 33028
      • Memorial Healthcare System
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute of Emory University
  • Illinois
    • Lisle, Illinois, United States, 60532
      • DuPage Medical Group
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University Hospitals Seidman Cancer Center
    • Troy, Michigan, United States, 48084
      • Michigan Institute of Urology
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Adult Pediatric Urology & Urogynecology, P.C
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Garden State Urology
    • Voorhees Township, New Jersey, United States, 08043
      • New Jersey Urology LLC
  • New York
    • The Bronx, New York, United States, 10461
      • Cardiology Clinic at Montefiore Hutchinson Complex
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Greenville, North Carolina, United States, 27834
      • Vidant Urology - Greenville
    • Winston-Salem, North Carolina, United States, 27103
      • Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Wexner Medical Center at the Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • MidLantic Urology
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
  • Texas
    • Houston, Texas, United States, 77027
      • Houston Metro Urology
    • League City, Texas, United States, 77573
      • University of Texas Medical Branch
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ineligible for or have elected not to undergo radical cystectomy
• All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade less than (<) 2 prior to randomization
• Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
• Thyroid function tests are within the normal range per investigator assessment (or stable on hormone supplementation). Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal test results
• Adequate bone marrow, liver, and renal function: Bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding two weeks): Absolute neutrophil count (ANC) greater than or equal to (>=) 1,500/cubic millimeters (mm^3); Platelet count >=80,000/mm^3; Hemoglobin >=9.0 grams per deciliter (g/dL); Liver function: (Total bilirubin less than or equal to (<=) 1.5 * upper limit of normal (ULN) or direct bilirubin <= ULN for participants with total bilirubin levels greater than (>)1.5*ULN (except participants with Gilbert's Syndrome, who must have a total bilirubin < 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (<=) 2.5* institutional ULN); Renal function: Creatinine clearance >=30 mL/min using the Cockcroft-Gault formula. 24-hour creatinine clearance test will also be accepted for estimating renal function in situations where Cockcroft-Gault formula is not a good predictor of estimating adequate renal function

Exclusion Criteria:

• Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study
• Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multi-focal, CIS is defined as the presence of at least 4 distinct CIS lesions in the bladder at the time of the Screening re-TURBT
• Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local radiology staging (chest, abdomen, and pelvis must be performed using Computed tomography [CT] or Magnetic resonance imaging [MRI]) within 42 days prior to randomization
• Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 200
• Evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has healed prior to randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAR-200 + Cetrelimab; Participants will receive intravesical TAR-200 every 3 weeks (21 days indwelling) for first 18 weeks and thereafter from Week 24 every 12 weeks through study Year 3 in combination with intravenous (IV) Cetrelimab.	Biological: Cetrelimab; Participants will receive intravenous Cetrelimab.; Other Names: JNJ-63723283; Drug: TAR-200; Participants will receive intravesical TAR-200.; Other Names: JNJ-17000139
Active Comparator: Chemotherapy (cisplatin or gemcitabine) + Radiation Therapy; Participants will receive chemotherapy based on investigator's choice from either cisplatin intravenously once weekly for 4 to 6 treatment weeks or gemcitabine intravenously twice weekly for 4 to 6 treatment weeks as Standard of Care (SOC) along with radiation therapy from either conventional radiotherapy (64 Gray [Gy], bladder only) for up to 6.5 treatment weeks or hypo-fractionated radiotherapy (55 Gy, bladder only) for up to 4 weeks.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event	Time from randomization to the first BI-EFS event includes histologically proven presence of muscle-invasive bladder cancer (MIBC), clinical evidence of nodal or metastatic disease (as assessed by RECIST 1.1 criteria), radical cystectomy (RC), or death due to any cause.	Up to 8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as time from randomization to death.	Up to 8 years
Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)	Number of Participants with AEs by Severity as assessed by CTCAE version 5 will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.	Up to 8 years
Number of Participants with AEs by Severity according to Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)	NCI PRO-CTCAE is a patient-reported item library used to evaluate symptomatic treatment-emergent adverse events in participants on cancer clinical trials. The items selected for this study include all NCI PRO-CTCAE gastrointestinal items and urinary items. These items include taste changes, decreased appetite, nausea, vomiting, heartburn, gas, bloating, hiccups, constipation, diarrhea, abdominal pain, fecal incontinence, painful, urination, urinary urgency, urinary frequency, change in usual urine color, and urinary incontinence.	Up to 8 years
Number of Participants with Clinical Laboratory Abnormalities	Number of participants with clinical laboratory abnormalities will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.	Up to 8 years
Metastasis-free survival (MFS)	MFS is measured from time from randomization to first radiologic (as assessed by RECIST 1.1 criteria) evidence of metastatic disease or death due to any cause.	Up to 8 years
Overall Response Rate (ORR)	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR). CR is defined as Negative biopsy, and Computed tomography/Magnetic resonance imaging (CT/MRI) showing no evidence of locally advanced or metastatic disease. PR (down-staging) is defined as biopsy proven non-muscle invasive disease (Ta, T1, Tis) and CT/MRI showing no evidence of locally advanced or metastatic disease. Non-Response (NR) includes those not achieving a CR or PR. Those who do not undergo a biopsy will be considered Non-Evaluable (NE).	Up to 8 years

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trials, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Platinum Compounds; Gemcitabine; Cisplatin
• Other Study ID Numbers: CR108917; 2020-002620-36 (EudraCT Number); 17000139BLC3001 (Other Identifier: Janssen Research & Development, LLC); 2023-507188-21-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No