AzTrials
AzTrials

Urinary Bladder NeoplasmsPhase 3SunRISe-2NCT04658862

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

A Phase 3 study testing Cetrelimab, TAR-200 and Cisplatin in people with Urinary Bladder Neoplasms, run by Janssen Research & Development, LLC at 290 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder Neoplasms
What is being tested?
Cetrelimab, TAR-200 and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
518 participants
Where
290 sitesin 25 countries
Study dates
7 Dec 2020to 31 Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

290 sites in 25 countries.

290 sites in 25 countries

United States28 sites

  • University Hospitals Seidman Cancer Center

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Wexner Medical Center at the Ohio State University

    Columbus, Ohio, 43210

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Foothills Urology - Golden Off

    Golden, Colorado, 80401

  • Vidant Urology - Greenville

    Greenville, North Carolina, 27834

  • Urological Research Network

    Hialeah, Florida, 33016

  • Houston Metro Urology

    Houston, Texas, 77027

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • University of Texas Medical Branch

    League City, Texas, 77573

  • DuPage Medical Group

    Lisle, Illinois, 60532

  • Loma Linda Univ Faculty Medic

    Loma Linda, California, 92354

  • University of Southern California

    Los Angeles, California, 90033

  • Garden State Urology

    Morristown, New Jersey, 07960

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Adult Pediatric Urology & Urogynecology, P.C

    Omaha, Nebraska, 68114

  • Memorial Healthcare System

    Pembroke Pines, Florida, 33028

  • Providence Saint John s Health Center

    Santa Monica, California, 90404

  • Stanford University Medical Center

    Stanford, California, 94305

  • Cardiology Clinic at Montefiore Hutchinson Complex

    The Bronx, New York, 10461

  • Michigan Institute of Urology

    Troy, Michigan, 48084

  • New Jersey Urology LLC

    Voorhees Township, New Jersey, 08043

  • Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

China24 sites

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

    Beijing, 100021

  • Peking University First Hospital

    Beijing, 100034

  • Peking University Third Hospital

    Beijing, 100191

  • Beijing Hospital

    Beijing, 100730

  • The First Hospital of Jilin University

    Changchun, 130021

  • The Third Xiangya Hospital of Central Sourth University

    Changsha, 410013

  • Hunan Cancer hospital

    Changsha Shi, 410013

  • West China Hospital of Sichuan University

    Chengdu, 610041

  • Chongqing University Cancer Hospital

    Chongqing, 400030

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510060

  • Guangzhou First Municipal People's Hospital

    Guangzhou, 510180

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310014

  • The First Hospital of Jiaxing

    Jiaxing, 314001

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Qingdao Municipal Hospital

    Qingdao, 266011

  • Ruijin Hospital

    Shanghai, 200003

  • Renji Hospital

    Shanghai, 200020

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300042

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • Wuhan Union Hospital

    Wuhan, 430023

  • Wuhan Tongji Hospital Tongji Medical College

    Wuhan, 430030

  • Yantai Yuhuangding Hospital

    Yantai, 264000

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Italy24 sites

  • Ospedale San Donato

    Arezzo, 52100

  • Fondazione del Piemonte per I Oncologia IRCC Candiolo

    Candiolo, 10060

  • Ospedale Civile Ramazzini

    Carpi, 41012

  • Ospedale Cannizzaro

    Catania, 95126

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

    Foggia, 71100

  • SPDC Villa Scassi

    Genova, 16100

  • Ospedale San Martino

    Genova, 16132

  • Ospedale Umberto I di Lugo

    Lugo, 48022

  • Ospedale San Raffaele

    Milan, 20132

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Istituto Oncologico Veneto - IRCCS 1

    Padova, 35128

  • Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani

    Pagani, 84016

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • ASL Napoli 2 Nord-SM delle Grazie Hospital

    Pozzuoli, 80078

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Azienda Ospedaliera Sant Andrea

    Roma, 00189

  • Universita Campus Bio-Medico di Roma

    Rome, 00128

  • Istituto Nazionale Tumori Regina Elena

    Rome, 00144

  • Istituto Clinico Humanitas Rozzano, IRCCS

    Rozzano, 20089

  • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte

    Siena, 53100

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

    Torino, 10126

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

  • Ospedale San Bortolo

    Vicenza, 36100

Other trials in Italy

France22 sites

  • Hopital Pellegrin CHU Bordeaux

    Bordeaux, 33076

  • ICH Hopital A. Morvan

    Brest, 29200

  • Hopital Cote de Nacre 1

    Caen, 14033

  • Pole Sante Leonard de Vinci

    Chambray-lès-Tours, 37170

  • Clinique Sainte Marguerite

    Hyères, 83400

  • CHRU Lille

    Lille, 59037

  • Polyclinique de Limoges - Francois Chenieux

    Limoges, 87000

  • Hôpital Edouard Herriot

    Lyon, 69437

  • Institut Paoli-Calmettes

    Marseille, 13009

  • Hôpital Européen

    Marseille, 13698

  • Institut Regional du Cancer de Montpellier

    Montpellier, 34298

  • CHU Nimes

    Nîmes, 30029

  • Institut Mutualiste Montsouris

    Paris, 75014

  • Hopital Europeen Georges-Pompidou

    Paris, 75015

  • Hôpital Bichat - Claude Bernard

    Paris, 75018

  • Hopital Tenon

    Paris, 75020

  • Clinical La Croix Du Sud - Ramsay Santé

    Quint-Fonsegrives, 31130

  • Centre hospitalier universitaire de St Etienne

    Saint-Etienne, 42270

  • Centre Hospitalier Prive

    Saint-Grégoire, 35760

  • Hopital Foch

    Suresnes, 92150

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54500

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Brazil21 sites

  • Fundacao Pio XII

    Barretos, 14784-400

  • Fundação Hospitalar São Francisco de Assis

    Belo Horizonte, 31110-580

  • Liga Paranaense de Combate ao Cancer

    Curitiba, 81520 060

  • Centro Regional Integrado de Oncologia CRIO

    Fortaleza, 60336-232

  • Clinica de Oncologia Reichow

    Jardim Blumenau, 89010 340

  • Fundacao Doutor Amaral Carvalho

    Jaú, 17210 080

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062-000

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Associacao Hospitalar Moinhos de Vento

    Porto Alegre, 90560032

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

  • Hospital Regional do Cancer Hospital de Esperanca

    Presidente Prudente, 19013-050

  • Hospital Sao Rafael

    Salvador, 41253 190

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060 650

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

    São José do Rio Preto, 15090-000

  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246 000

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01327 001

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

  • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE

    São Paulo, 04039-004

  • Sociedade Beneficente de Senhoras - Hospital Sirio Libanes

    São Paulo, 04784180

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652 900

  • Centro Oncológico do Triângulo

    Uberlândia, 38408-150

Other trials in Brazil

Germany15 sites

  • Klinikum Augsburg

    Augsburg, 86156

  • Staedtisches Klinikum Braunschweig

    Braunschweig, 38126 DE

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 1307

  • Universitatsklinikum Dusseldorf

    Düesseldorf, 40225

  • Urologicum Duisburg

    Duisburg, 47179

  • Klinik und Poliklinik für Urologie

    Essen, 45147

  • Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

    Frankfurt am Main, 60431

  • Universitatsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • SLK-Kliniken Heilbronn - Klinikum am Gesundbrunnen

    Heilbronn, D-74078

  • Klinikum Herne - Urologie

    Herne, 44625

  • Matthias Schulze - Germany

    Markkleeberg, 04416

  • Universitatsklinikum Munster

    Münster, 48149

  • Klinikum Nürnberg Nord - Hautklinik

    Nuremberg, 90419

  • Krankenhaus der Barmherzigen Bruder Trier

    Trier, 54292

Other trials in Germany

Spain14 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Fund. Puigvert

    Barcelona, 08025

  • Hosp Univ Vall D Hebron

    Barcelona, 8035

  • Hosp. Univ. Virgen de Las Nieves

    Granada, 18014

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Clinica Univ. de Navarra

    Madrid, 28027

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. de La Paz

    Madrid, 28046

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Instituto Valenciano de Oncologia

    Valencia, 46009

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010

Other trials in Spain

Japan13 sites

  • Aso Co.,Ltd Iizuka Hospital

    Iizuka, 820-8501

  • St Marianna University Hospital

    Kanagawa, 216 8511

  • Nara Medical University Hospital

    Kashihara, 634-8522

  • Saitama Medical University Hospital

    Kawagoe-Shi, 350-8550

  • Kimitsu Chuo Hospital

    Kisarazu-shi, 292-8535

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • JOHAS Osaka Rosai Hospital

    Osaka, 591-8025

  • Tokuyama Central Hospital

    Shūnan, 745-8522

  • Toranomon Hospital

    Tokyo, 105-8470

  • Nippon Medical School Hospital

    Tokyo, 113 8603

  • Fujita Health University Hospital

    Toyoake, 470-1192

  • Yamaguchi University Hospital

    Ube, 755-8505

  • Yokohama City University Medical Center

    Yokohama, 232 0024

Other trials in Japan

South Korea13 sites

  • Inje University Haeundae Paik Hospital

    Busan, 612-896

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • Samsung Medical Center

    Gangnam Gu, 06351

  • National Cancer Center

    Goyang-si, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, 58128

  • Gachon University Gil Medical Center

    Namdong, 405 760

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Gangnam Severance Hospital

    Seoul, 06273

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591

  • Hanyang University Hospital

    Seoul, 4763

  • Pusan National University Yangsan Hospital

    Yangsan, 50612

Other trials in South Korea

Russia12 sites

  • Altlay Regional Oncology Dispensary

    Barnaul, 656045

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • Krasnoyarsk Regional Oncology Dispensary

    Krasnoyarsk, 660133

  • Hertzen Oncology Research Institute

    Moscow, 125284

  • A. Tsyb Medical Radiological Research Center

    Obninsk, 249031

  • BHI of Omsk region Clinical Oncology Dispensary

    Omsk, 644013

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

    Ryazan, 390011

  • N.N. Petrov Research Institute Of Oncology

    Saint Petersburg, 197758

  • Ogarev Mordovian State University

    Saransk, 430005

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

    Sochi, 354057

  • Multifunctional clinical medical center 'Medical city'

    Tyumen, 625041

  • Bashkir State Medical University

    Ufa, 450008

Other trials in Russia

Turkey (Türkiye)12 sites

  • Adana Baskent Yuregir Hospital

    Adana

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

    Ankara, 06050

  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

    Ankara, 06100

  • Dokuz Eylul Universitesi Tip Fakultesi

    Balçova, 35330

  • Bezmialem University Medical Faculty

    Fatih, 34093

  • Medical Park Gaziantep Hastanesi

    Gaziantep, 27584

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34096

  • Istanbul Medeniyet University Goztepe Training and Research Hospital

    Istanbul, 34732

  • Izmir Medical Park Hospital

    Izmir, 35530

  • Inonu University Medical Faculty

    Malatya, 44280

  • Erciyes Univ MKD Hospital

    Melikgazi, 38039

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

    Seyhan, 01330

Other trials in Turkey (Türkiye)

Argentina11 sites

  • Fundacion Intecnus

    Bariloche, 8400

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB

  • Asociacion de Beneficencia Hospital Sirio Libanes

    Buenos Aires, C1419AHN

  • Instituto Medico Especializado Alexander Fleming

    Buenos Aires, C1426ANZ

  • Centro de Urologia (CDU)

    Ciudad Automoma Buenos Aires, C1120AAT

  • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, 5000

  • Centro Urologico Profesor Bengio

    Córdoba, X5000KPH

  • Sanatorio Allende Cerro

    Córdoba, X5021FPQ

  • Centro Oncologico Riojano Integral (Cori)

    La Rioja, F5300COE

  • Centro de Investigacion Pergamino SA

    Pergamino, B2700CPM

  • CEDIC Centro de Investigaciones Clinicas

    Viedma, R8500EYO

Other trials in Argentina

Mexico11 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280

  • Consultorio Privado Dr Jose Arturo Rodriguez Rivera

    Guadalajara, 45050

  • Centro De Estudio Y Prevencion Del Cancer

    Juchitán de Zaragoza, 70000

  • Dr. Marco Antonio Badillo Santoyo

    León, 37000

  • Oncologia Integral Satelite

    Mexico City, 06720

  • i Can Oncology Center

    Monterrey, 64710

  • Centro de Investigacion Clinica Chapultepec

    Morelia, 58260

  • Oaxaca Site Management Organization S.C.

    Oaxaca City, 68000

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020

  • Oncologico Potosino

    San Luis Potosí City, 78209

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

    Zapopan, 45070

Other trials in Mexico

Greece9 sites

  • Alexandra General Hospital of Athens

    Athens, 11528

  • Metropolitan General A E

    Cholargós, 155 62

  • Athens Medical Center

    Marousi, 151 25

  • Metropolitan Hospital

    Neo Faliro, 18547

  • Interbalkan Medical Center of Thessaloniki

    Thessaloniki, 546 22

  • Euromedica General Clinic

    Thessaloniki, 54645

  • Clinic Agios Loukas

    Thessaloniki, 55236

  • Papageorgiou General Hospital Of Thessaloniki

    Thessaloniki, TK 56403

  • Anassa General Clinic

    Volos, 38333

Other trials in Greece

India9 sites

  • Sujan Surgical Cancer Hospital & Amravati Cancer Foundation

    Amravati, 400601

  • Bangalore Medical College and Research Institute

    Bangalore, 560002

  • Acharya Tulsi Regional Cancer Treatment Research Institute

    Bikaner, 334 003

  • Shatabdi Super Speciality Hospital

    Nashik, 422005

  • BLK Super Specialty Hospital

    New Delhi, 110005

  • Aakash Healthcare Super Speciality Hospital

    New Delhi, 110075

  • Rajiv Gandhi Cancer Institute & Research Centre

    New Delhi, 110085

  • Indira Gandhi Institute of Medical Sciences

    Patna, 800014

  • Jehangir Clinical Development Center Pvt Ltd

    Pune, 411001

Other trials in India

Ukraine9 sites

  • Chernihivskyi oblasnyi onkolohichnyi dyspanser

    Chernihiv, 14029

  • SE Dnipropetrovsk Medical Academy

    Dnipro, 49005

  • Kharkiv Regional Clinical Hospital

    Kharkiv, 61070

  • Khersonsky Regional Oncology Center

    Kherson, 73000

  • Asklepion LLC

    Kiev, 08173

  • Kyiv City Clinical Hospital #3

    Kyiv, 02660

  • State Institution Academy Of Medical Sciences Of Ukraine

    Kyiv, 04053

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

    Kyiv, 04112

  • Lviv Regional Clinical Hospital

    Lviv, 79000

Other trials in Ukraine

Czechia8 sites

  • Slezska nemocnice v Opave

    Opava, 746 01

  • Fakultni nemocnice Plze

    Plzen-Bory, 305 99

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Urocentrum Praha

    Prague, 120 00

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Thomayerova nemocnice

    Prague, 140 59

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • Nemocnice Na Bulovce

    Prague, 180 81

Other trials in Czechia

Taiwan7 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10048

  • Tri-Service General Hospital

    Taipei, 11490

  • Chang Gung Memorial Hospital Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Belgium6 sites

  • Hopital Erasme

    Anderlecht, 1070

  • ZNA Middelheim

    Antwerp, 2020

  • AZ Sint-Lucas

    Assebroek, 8310

  • AZ Sint Jan Brugge Oostende AV

    Bruges, 8000

  • Az Groeninge

    Kortrijk, 8500

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

Other trials in Belgium

Portugal6 sites

  • Hospital Garcia de Orta

    Almada, 2805-267

  • Centro Hospitalar e Universitario de Coimbra

    Coimbra, 3000075

  • Centro Hospitalar de Lisboa Central

    Lisbon, 1150-199

  • Fund. Champalimaud

    Lisbon, 1400-038

  • H. Santa Maria - Centro Hospitalar de Lisboa Norte

    Lisbon, 1649-035

  • Hospital de Sao Joao

    Porto, 4200-319

Other trials in Portugal

Hungary5 sites

  • Eszak Pesti Centrumkorhaz Honvedkorhaz

    Budapest, 1062

  • Bajcsy-Zsilinszky Kórház és Rendelőintézet

    Budapest, 1106

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

Other trials in Hungary

Poland4 sites

  • Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

    Siedlce, 08-110

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60 185

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, 02-507

  • Uniwersytecki Szpital Kliniczny

    Wroclaw, 50556

Other trials in Poland

Austria3 sites

  • Krankenhaus der barmherzigen Schwestern

    Linz, 4010

  • Universitaetsklinikum Salzburg Landeskrankenhaus

    Salzburg, 5020

  • Medizinische Universitaet Wien

    Vienna, 1090

Other trials in Austria

Canada3 sites

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • CHU de Quebec L Hotel Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5H3

Other trials in Canada

Australia1 site

  • Flinders Medical Centre

    Bedford Park, 5042

Other trials in Australia

About this study

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

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.

Being tested
Cetrelimab, TAR-200, Cisplatin, Gemcitabine, Conventional radiation therapy
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CetrelimabBiological

    Also called JNJ-63723283

    Participants will receive intravenous Cetrelimab.

  • TAR-200Drug

    Also called JNJ-17000139

    Participants will receive intravesical TAR-200.

  • CisplatinDrug

    Participants will receive cisplatin intravenously.

  • GemcitabineDrug

    Participants will receive gemcitabine intravenously.

  • Conventional radiation therapyRadiation

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

  • Hypo-fractioned radiation therapyRadiation

    Participants will receive hypo-fractioned radiation therapy for bladder (55 gy).

Study groups in NCT04658862
Study groupRoleWhat they receive
TAR-200 + CetrelimabExperimentalParticipants 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.
Receives: Biological: Cetrelimab; Drug: TAR-200
Chemotherapy (cisplatin or gemcitabine) + Radiation TherapyActive comparatorParticipants 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.
Receives: Drug: Cisplatin; Drug: Gemcitabine; Radiation: Conventional radiation therapy; Radiation: Hypo-fractioned radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 8 years

Secondary outcomes (6)

  1. 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.

    Measured: Up to 8 years

  2. Overall Survival (OS)

    OS is defined as time from randomization to death.

    Measured: Up to 8 years

  3. 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).

    Measured: Up to 8 years

  4. 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.

    Measured: Up to 8 years

  5. 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.

    Measured: Up to 8 years

  6. 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.

    Measured: Up to 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start7 Dec 2020
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
518 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04658862
Sponsor's protocol ID
CR108917
Other IDs
17000139BLC3001, 2020-002620-36, 2023-507188-21-00, 2023
Acronym
SunRISe-2
Status last verified
Sep 2026
First submitted
19 Nov 2020
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cetrelimab, TAR-200 and Cisplatin in people with Urinary Bladder Neoplasms, run by Janssen Research & Development, LLC at 290 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 290 sites in United States, China, Italy, France, Brazil and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event (time frame: Up to 8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04658862.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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