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
4 other identifiers
interventional
518
24 countries
287
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2020
Longer than P75 for phase_3
287 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2020
CompletedStudy Start
First participant enrolled
December 7, 2020
CompletedFirst Posted
Study publicly available on registry
December 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 13, 2026
April 1, 2026
6.1 years
November 19, 2020
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (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.
Up to 8 years
Secondary Outcomes (6)
Metastasis-free survival (MFS)
Up to 8 years
Overall Survival (OS)
Up to 8 years
Overall Response Rate (ORR)
Up to 8 years
Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)
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)
Up to 8 years
- +1 more secondary outcomes
Study Arms (2)
TAR-200 + Cetrelimab
EXPERIMENTALParticipants 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.
Chemotherapy (cisplatin or gemcitabine) + Radiation Therapy
ACTIVE 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.
Interventions
Participants will receive gemcitabine intravenously.
Participants will receive conventional radiation therapy for bladder (64 gy).
Participants will receive hypo-fractioned radiation therapy for bladder (55 gy).
Participants will receive intravenous Cetrelimab.
Participants will receive intravesical TAR-200.
Participants will receive cisplatin intravenously.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (290)
Loma Linda Univ Faculty Medic
Loma Linda, California, 92354, United States
University of Southern California
Los Angeles, California, 90033, United States
Providence Saint John s Health Center
Santa Monica, California, 90404, United States
Stanford University Medical Center
Stanford, California, 94305, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
Foothills Urology - Golden Off
Golden, Colorado, 80401, United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486, United States
Urological Research Network
Hialeah, Florida, 33016, United States
Memorial Healthcare System
Pembroke Pines, Florida, 33028, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
DuPage Medical Group
Lisle, Illinois, 60532, United States
University Hospitals Seidman Cancer Center
Ann Arbor, Michigan, 48109, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
Adult Pediatric Urology & Urogynecology, P.C
Omaha, Nebraska, 68114, United States
Garden State Urology
Morristown, New Jersey, 07960, United States
New Jersey Urology LLC
Voorhees Township, New Jersey, 08043, United States
Cardiology Clinic at Montefiore Hutchinson Complex
The Bronx, New York, 10461, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Vidant Urology - Greenville
Greenville, North Carolina, 27834, United States
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem, North Carolina, 27103, United States
Wexner Medical Center at the Ohio State University
Columbus, Ohio, 43210, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Houston Metro Urology
Houston, Texas, 77027, United States
University of Texas Medical Branch
League City, Texas, 77573, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Fundacion Intecnus
Bariloche, 8400, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB, Argentina
Asociacion de Beneficencia Hospital Sirio Libanes
Buenos Aires, C1419AHN, Argentina
Instituto Medico Especializado Alexander Fleming
Buenos Aires, C1426ANZ, Argentina
Centro de Urologia (CDU)
Ciudad Automoma Buenos Aires, C1120AAT, Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, 5000, Argentina
Centro Urologico Profesor Bengio
Córdoba, X5000KPH, Argentina
Sanatorio Allende Cerro
Córdoba, X5004FHP, Argentina
Centro Oncologico Riojano Integral (Cori)
La Rioja, F5300COE, Argentina
Centro de Investigacion Pergamino SA
Pergamino, B2700CPM, Argentina
CEDIC Centro de Investigaciones Clinicas
Viedma, R8500EYO, Argentina
Flinders Medical Centre
Bedford Park, 5042, Australia
Krankenhaus der barmherzigen Schwestern
Linz, 4010, Austria
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, 5020, Austria
Medizinische Universitaet Wien
Vienna, 1090, Austria
Hopital Erasme
Anderlecht, 1070, Belgium
ZNA Middelheim
Antwerp, 2020, Belgium
AZ Sint-Lucas
Assebroek, 8310, Belgium
AZ Sint Jan Brugge Oostende AV
Bruges, 8000, Belgium
Az Groeninge
Kortrijk, 8500, Belgium
Algemeen Ziekenhuis Delta
Roeselare, 8800, Belgium
Fundacao Pio XII
Barretos, 14784-400, Brazil
Fundação Hospitalar São Francisco de Assis
Belo Horizonte, 31110-580, Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, 81520 060, Brazil
Centro Regional Integrado de Oncologia CRIO
Fortaleza, 60336-232, Brazil
Clinica de Oncologia Reichow
Jardim Blumenau, 89010 340, Brazil
Fundacao Doutor Amaral Carvalho
Jaú, 17210 080, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062-000, Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, 90035 901, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
Hospital Regional do Cancer - Hospital de Esperança
Presidente Prudente, 19013-050, Brazil
Hospital Sao Rafael
Salvador, 41253 190, Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, 09060 650, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, 15090-000, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246 000, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, 01327 001, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01509 900, Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
São Paulo, 04039-004, Brazil
Sociedade Beneficente de Senhoras - Hospital Sirio Libanes
São Paulo, 04784180, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652 900, Brazil
Centro Oncológico do Triângulo
Uberlândia, 38408-150, Brazil
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
CHU de Quebec L Hotel Dieu de Quebec
Québec, Quebec, G1R 2J6, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5H3, Canada
Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)
Beijing, 100021, China
Peking University First Hospital
Beijing, 100034, China
Peking University Third Hospital
Beijing, 100191, China
Beijing Hospital
Beijing, 100730, China
The First Hospital of Jilin University
Changchun, 130021, China
The Third Xiangya Hospital of Central Sourth University
Changsha, 410013, China
Hunan Cancer hospital
Changsha Shi, 410013, China
West China Hospital of Sichuan University
Chengdu, 610041, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
Sun Yat Sen University Cancer Center
Guangzhou, 510060, China
Guangzhou First Municipal People's Hospital
Guangzhou, 510180, China
Zhejiang Provincial People's Hospital
Hangzhou, 310014, China
The First Hospital of Jiaxing
Jiaxing, 314001, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Qingdao Municipal Hospital
Qingdao, 266011, China
Ruijin Hospital
Shanghai, 200003, China
Renji Hospital
Shanghai, 200020, China
Shengjing Hospital Of China Medical University
Shenyang, 110004, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300042, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Wuhan Union Hospital
Wuhan, 430023, China
Wuhan Tongji Hospital Tongji Medical College
Wuhan, 430030, China
Yantai Yuhuangding Hospital
Yantai, 264000, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Slezska nemocnice v Opave
Opava, 746 01, Czechia
Fakultni nemocnice Plze
Plzen-Bory, 305 99, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Urocentrum Praha
Prague, 120 00, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Thomayerova nemocnice
Prague, 140 59, Czechia
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
Nemocnice Na Bulovce
Prague, 180 81, Czechia
Hopital Pellegrin CHU Bordeaux
Bordeaux, 33076, France
ICH Hopital A. Morvan
Brest, 29200, France
Hopital Cote de Nacre 1
Caen, 14033, France
Pole Sante Leonard de Vinci
Chambray-lès-Tours, 37170, France
Clinique Sainte Marguerite
Hyères, 83400, France
CHRU Lille
Lille, 59037, France
Polyclinique de Limoges - Francois Chenieux
Limoges, 87000, France
Hôpital Edouard Herriot
Lyon, 69437, France
Institut Paoli-Calmettes
Marseille, 13009, France
Hôpital Européen
Marseille, 13698, France
Institut Regional du Cancer de Montpellier
Montpellier, 34298, France
CHU Nimes
Nîmes, 30029, France
Institut Mutualiste Montsouris
Paris, 75014, France
Hopital Europeen Georges-Pompidou
Paris, 75015, France
Hôpital Bichat - Claude Bernard
Paris, 75018, France
Hopital Tenon
Paris, 75020, France
Clinical La Croix Du Sud - Ramsay Santé
Quint-Fonsegrives, 31130, France
Centre hospitalier universitaire de St Etienne
Saint-Etienne, 42270, France
Centre Hospitalier Prive
Saint-Grégoire, 35760, France
Hopital Foch
Suresnes, 92150, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54500, France
Gustave Roussy
Villejuif, 94805, France
Klinikum Augsburg
Augsburg, 86156, Germany
Staedtisches Klinikum Braunschweig
Braunschweig, 38126 DE, Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, 1307, Germany
Urologicum Duisburg
Duisburg, 47179, Germany
Universitatsklinikum Dusseldorf
Düesseldorf, 40225, Germany
Klinik und Poliklinik für Urologie
Essen, 45147, Germany
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
Frankfurt am Main, 60431, Germany
Universitatsklinikum Frankfurt
Frankfurt am Main, 60590, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
SLK-Kliniken Heilbronn - Klinikum am Gesundbrunnen
Heilbronn, D-74078, Germany
Klinikum Herne - Urologie
Herne, 44625, Germany
Matthias Schulze - Germany
Markkleeberg, 04416, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
Klinikum Nürnberg Nord - Hautklinik
Nuremberg, 90419, Germany
Krankenhaus der Barmherzigen Bruder Trier
Trier, 54292, Germany
Alexandra General Hospital of Athens
Athens, 11528, Greece
Metropolitan General A E
Cholargós, 155 62, Greece
Athens Medical Center
Marousi, 151 25, Greece
Metropolitan Hospital
Neo Faliro, 18547, Greece
Interbalkan Medical Center of Thessaloniki
Thessaloniki, 546 22, Greece
Euromedica General Clinic
Thessaloniki, 54645, Greece
Clinic Agios Loukas
Thessaloniki, 55236, Greece
Papageorgiou General Hospital Of Thessaloniki
Thessaloniki, TK 56403, Greece
Anassa General Clinic
Volos, 38333, Greece
Eszak Pesti Centrumkorhaz Honvedkorhaz
Budapest, 1062, Hungary
Bajcsy-Zsilinszky Kórház és Rendelőintézet
Budapest, 1106, Hungary
Orszagos Onkologiai Intezet
Budapest, 1122, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, 4400, Hungary
Sujan Surgical Cancer Hospital & Amravati Cancer Foundation
Amravati, 400601, India
Bangalore Medical College and Research Institute
Bangalore, 560002, India
Acharya Tulsi Regional Cancer Treatment Research Institute
Bikaner, 334 003, India
Shatabdi Super Speciality Hospital
Nashik, 422005, India
BLK Super Specialty Hospital
New Delhi, 110005, India
Aakash Healthcare Super Speciality Hospital
New Delhi, 110075, India
Rajiv Gandhi Cancer Institute & Research Centre
New Delhi, 110085, India
Indira Gandhi Institute of Medical Sciences
Patna, 800014, India
Jehangir Clinical Development Center Pvt Ltd
Pune, 411001, India
Ospedale San Donato
Arezzo, 52100, Italy
Fondazione del Piemonte per I Oncologia IRCC Candiolo
Candiolo, 10060, Italy
Ospedale Civile Ramazzini
Carpi, 41012, Italy
Ospedale Cannizzaro
Catania, 95126, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia, 71100, Italy
SPDC Villa Scassi
Genova, 16100, Italy
Ospedale San Martino
Genova, 16132, Italy
Ospedale Umberto I di Lugo
Lugo, 48022, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, 80131, Italy
Istituto Oncologico Veneto - IRCCS 1
Padova, 35128, Italy
Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani
Pagani, 84016, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
ASL Napoli 2 Nord-SM delle Grazie Hospital
Pozzuoli, 80078, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Azienda Ospedaliera Sant Andrea
Roma, 00189, Italy
Universita Campus Bio-Medico di Roma
Rome, 00128, Italy
Istituto Nazionale Tumori Regina Elena
Rome, 00144, Italy
Istituto Clinico Humanitas Rozzano, IRCCS
Rozzano, 20089, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
Siena, 53100, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, 10126, Italy
Ospedale di Circolo e Fondazione Macchi
Varese, 21100, Italy
Ospedale San Bortolo
Vicenza, 36100, Italy
Aso Co.,Ltd Iizuka Hospital
Iizuka, 820-8501, Japan
St Marianna University Hospital
Kanagawa, 216 8511, Japan
Nara Medical University Hospital
Kashihara, 634-8522, Japan
Saitama Medical University Hospital
Kawagoe-Shi, 350-8550, Japan
Kimitsu Chuo Hospital
Kisarazu-shi, 292-8535, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
JOHAS Osaka Rosai Hospital
Osaka, 591-8025, Japan
Tokuyama Central Hospital
Shūnan, 745-8522, Japan
Toranomon Hospital
Tokyo, 105-8470, Japan
Nippon Medical School Hospital
Tokyo, 113 8603, Japan
Fujita Health University Hospital
Toyoake, 470-1192, Japan
Yamaguchi University Hospital
Ube, 755-8505, Japan
Yokohama City University Medical Center
Yokohama, 232 0024, Japan
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280, Mexico
Consultorio Privado Dr Jose Arturo Rodriguez Rivera
Guadalajara, 45050, Mexico
Centro De Estudio Y Prevencion Del Cancer
Juchitán de Zaragoza, 70000, Mexico
Dr. Marco Antonio Badillo Santoyo
León, 37000, Mexico
Oncologia Integral Satelite
Mexico City, 06720, Mexico
i Can Oncology Center
Monterrey, 64710, Mexico
Centro de Investigacion Clinica Chapultepec
Morelia, 58260, Mexico
Oaxaca Site Management Organization S.C.
Oaxaca City, 68000, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, 68020, Mexico
Oncologico Potosino
San Luis Potosí City, 78209, Mexico
Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V.
Zapopan, 45070, Mexico
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
Siedlce, 08-110, Poland
Centrum Medyczne Pratia Poznan
Skorzewo, 60 185, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, 02-507, Poland
Uniwersytecki Szpital Kliniczny
Wroclaw, 50556, Poland
Hospital Garcia de Orta
Almada, 2805-267, Portugal
Centro Hospitalar e Universitario de Coimbra
Coimbra, 3000075, Portugal
Centro Hospitalar de Lisboa Central
Lisbon, 1150-199, Portugal
Fund. Champalimaud
Lisbon, 1400-038, Portugal
H. Santa Maria - Centro Hospitalar de Lisboa Norte
Lisbon, 1649-035, Portugal
Hospital de Sao Joao
Porto, 4200-319, Portugal
Altlay Regional Oncology Dispensary
Barnaul, 656045, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040, Russia
Krasnoyarsk Regional Oncology Dispensary
Krasnoyarsk, 660133, Russia
Hertzen Oncology Research Institute
Moscow, 125284, Russia
A. Tsyb Medical Radiological Research Center
Obninsk, 249031, Russia
BHI of Omsk region Clinical Oncology Dispensary
Omsk, 644013, Russia
Ryazan State Medical University named after I.P.Pavlov
Ryazan, 390011, Russia
N.N. Petrov Research Institute Of Oncology
Saint Petersburg, 197758, Russia
Ogarev Mordovian State University
Saransk, 430005, Russia
State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio
Sochi, 354057, Russia
Multifunctional clinical medical center 'Medical city'
Tyumen, 625041, Russia
Bashkir State Medical University
Ufa, 450008, Russia
Inje University Haeundae Paik Hospital
Busan, 612-896, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Samsung Medical Center
Gangnam Gu, 06351, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, 58128, South Korea
Gachon University Gil Medical Center
Namdong, 405 760, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591, South Korea
Hanyang University Hospital
Seoul, 4763, South Korea
Pusan National University Yangsan Hospital
Yangsan, 50612, South Korea
Hosp Univ A Coruna
A Coruña, 15006, Spain
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
Fund. Puigvert
Barcelona, 08025, Spain
Hosp Univ Vall D Hebron
Barcelona, 8035, Spain
Hosp. Univ. Virgen de Las Nieves
Granada, 18014, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407, Spain
Clinica Univ. de Navarra
Madrid, 28027, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. de La Paz
Madrid, 28046, Spain
Hosp Univ Hm Sanchinarro
Madrid, 28050, Spain
Corporacio Sanitari Parc Tauli
Sabadell, 08208, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Instituto Valenciano de Oncologia
Valencia, 46009, Spain
Hosp. Clinico Univ. de Valencia
Valencia, 46010, Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Chang Gung Memorial Hospital Linkou Branch
Taoyuan District, 333, Taiwan
Adana Baskent Yuregir Hospital
Adana, Turkey (Türkiye)
Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital
Ankara, 06050, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Ankara, 06100, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Balçova, 35330, Turkey (Türkiye)
Bezmialem University Medical Faculty
Fatih, 34093, Turkey (Türkiye)
Medical Park Gaziantep Hastanesi
Gaziantep, 27584, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34096, Turkey (Türkiye)
Istanbul Medeniyet University Goztepe Training and Research Hospital
Istanbul, 34732, Turkey (Türkiye)
Izmir Medical Park Hospital
Izmir, 35530, Turkey (Türkiye)
Inonu University Medical Faculty
Malatya, 44280, Turkey (Türkiye)
Erciyes Univ MKD Hospital
Melikgazi, 38039, Turkey (Türkiye)
T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma Hastanesi
Seyhan, 01330, Turkey (Türkiye)
Chernihivskyi oblasnyi onkolohichnyi dyspanser
Chernihiv, 14029, Ukraine
SE Dnipropetrovsk Medical Academy
Dnipro, 49005, Ukraine
Kharkiv Regional Clinical Hospital
Kharkiv, 61070, Ukraine
Khersonsky Regional Oncology Center
Kherson, 73000, Ukraine
Asklepion LLC
Kiev, 08173, Ukraine
Kyiv City Clinical Hospital #3
Kyiv, 02660, Ukraine
State Institution Academy Of Medical Sciences Of Ukraine
Kyiv, 04053, Ukraine
P.L. Shupyk National Medical Academy of Post-Graduate Education
Kyiv, 04112, Ukraine
Lviv Regional Clinical Hospital
Lviv, 79000, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trials
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
November 19, 2020
First Posted
December 9, 2020
Study Start
December 7, 2020
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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