Clinical trial NCT04658862: A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Urinary Bladder Neoplasms
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-12-09
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event
timeFrame: Up to 8 years
Secondary outcomes:
measure: Metastasis-free survival (MFS)
timeFrame: Up to 8 years
measure: Overall Survival (OS)
timeFrame: Up to 8 years
measure: Overall Response Rate (ORR)
timeFrame: Up to 8 years
measure: Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: Up to 8 years
measure: Number of Participants with AEs by Severity according to Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)
timeFrame: Up to 8 years
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Up to 8 years
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Univ Faculty Medic
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Santa Monica
country: United States
facility: Providence Saint John s Health Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Golden
country: United States
facility: Foothills Urology - Golden Off
state: Colorado
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital
state: Florida
city: Hialeah
country: United States
facility: Urological Research Network
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Healthcare System
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Lisle
country: United States
facility: DuPage Medical Group
state: Illinois
city: Ann Arbor
country: United States
facility: University Hospitals Seidman Cancer Center
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Omaha
country: United States
facility: Adult Pediatric Urology & Urogynecology, P.C
state: Nebraska
city: Morristown
country: United States
facility: Garden State Urology
state: New Jersey
city: Voorhees
country: United States
facility: New Jersey Urology LLC
state: New Jersey
city: Bronx
country: United States
facility: Cardiology Clinic at Montefiore Hutchinson Complex
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: Vidant Urology - Greenville
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
state: North Carolina
city: Columbus
country: United States
facility: Wexner Medical Center at the Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: League City
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Bariloche
country: Argentina
facility: Fundacion Intecnus
city: Buenos Aires
country: Argentina
facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes
city: Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming
city: Ciudad Automoma Buenos Aires
country: Argentina
facility: Centro de Urologia (CDU)
city: Ciudad Autónoma De Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Cordoba
country: Argentina
facility: Centro Urologico Profesor Bengio
city: Córdoba
country: Argentina
facility: Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
city: Córdoba
country: Argentina
facility: Sanatorio Allende Cerro
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (Cori)
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino SA
city: Viedma
country: Argentina
facility: CEDIC Centro de Investigaciones Clinicas
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Linz
country: Austria
facility: Krankenhaus der barmherzigen Schwestern
city: Salzburg
country: Austria
facility: Universitaetsklinikum Salzburg Landeskrankenhaus
city: Wien
country: Austria
facility: Medizinische Universitaet Wien
city: Anderlecht
country: Belgium
facility: Hopital Erasme
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Assebroek
country: Belgium
facility: AZ Sint-Lucas
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge Oostende AV
city: Kortrijk
country: Belgium
facility: Az Groeninge
city: Roeselare
country: Belgium
facility: Algemeen Ziekenhuis Delta
city: Barretos
country: Brazil
facility: Fundacao Pio XII
city: Belo Horizonte
country: Brazil
facility: Fundação Hospitalar São Francisco de Assis
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer
city: Fortaleza
country: Brazil
facility: Centro Regional Integrado de Oncologia CRIO
city: Jardim Blumenau
country: Brazil
facility: Clinica de Oncologia Reichow
city: Jau
country: Brazil
facility: Fundacao Doutor Amaral Carvalho
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
city: Presidente Prudente
country: Brazil
facility: Hospital Regional do Cancer - Hospital de Esperança
city: Salvador
country: Brazil
facility: Hospital Sao Rafael
city: Santo Andre
country: Brazil
facility: CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
city: Sao Paulo
country: Brazil
facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente A C Camargo Cancer Center
city: Sao Paulo
country: Brazil
facility: Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras - Hospital Sirio Libanes
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
city: Uberlândia
country: Brazil
facility: Centro Oncológico do Triângulo
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Québec
country: Canada
facility: CHU de Quebec L Hotel Dieu de Quebec
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha Shi
country: China
facility: Hunan Cancer hospital
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central Sourth University
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Guang Zhou Shi
country: China
facility: Guangzhou First Municipal People's Hospital
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Shanghai
country: China
facility: Ruijin Hospital
city: Shanghai
country: China
facility: Renji Hospital
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Wenzhou Shi
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Wuhan
country: China
facility: Wuhan Tongji Hospital Tongji Medical College
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Opava
country: Czechia
facility: Slezska nemocnice v Opave
city: Plzen-Bory
country: Czechia
facility: Fakultni nemocnice Plze
city: Praha 2
country: Czechia
facility: Urocentrum Praha
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 4
country: Czechia
facility: Thomayerova nemocnice
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Praha 8
country: Czechia
facility: Nemocnice Na Bulovce
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Bordeaux
country: France
facility: Hopital Pellegrin CHU Bordeaux
city: Brest
country: France
facility: ICH Hopital A. Morvan
city: Caen Cedex 9
country: France
facility: Hôpital Côte de Nacre
city: Chambray-lès-Tours
country: France
facility: Pole Sante Leonard de Vinci
city: Hyeres
country: France
facility: Clinique Sainte Marguerite
city: Lille
country: France
facility: CHRU Lille
city: Limoges
country: France
facility: Polyclinique de Limoges - Francois Chenieux
city: Lyon Cedex 03
country: France
facility: Hôpital Edouard Herriot
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Marseille
country: France
facility: Hôpital Européen
city: Montpellier
country: France
facility: Institut Regional du Cancer de Montpellier
city: Nimes
country: France
facility: CHU Nimes
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hopital Europeen Georges-Pompidou
city: Paris
country: France
facility: Hôpital Bichat - Claude Bernard
city: Paris
country: France
facility: Hopital Tenon
city: Quint-Fonsegrives
country: France
facility: Clinical La Croix Du Sud - Ramsay Santé
city: Saint-Etienne Cedex 2
country: France
facility: Centre hospitalier universitaire de St Etienne
city: Saint-Grégoire
country: France
facility: Centre Hospitalier Prive
city: Suresnes
country: France
facility: Hopital Foch
city: Vandoeuvre les Nancy
country: France
facility: Institut de Cancerologie de Lorraine
city: Villejuif Cedex
country: France
facility: Gustave Roussy
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Braunschweig
country: Germany
facility: Staedtisches Klinikum Braunschweig
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus Dresden
city: Duisburg
country: Germany
facility: Urologicum Duisburg
city: Düesseldorf
country: Germany
facility: Universitatsklinikum Dusseldorf
city: Essen
country: Germany
facility: Klinik und Poliklinik für Urologie
city: Frankfurt Am Main
country: Germany
facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
city: Frankfurt am Main
country: Germany
facility: Universitatsklinikum Frankfurt
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn - Klinikum am Gesundbrunnen
city: Herne
country: Germany
facility: Klinikum Herne - Urologie
city: Markkleeberg
country: Germany
facility: Matthias Schulze - Germany
city: Münster
country: Germany
facility: Universitatsklinikum Munster
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord - Hautklinik
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Bruder Trier
city: Athens
country: Greece
facility: Alexandra General Hospital of Athens
city: Holargos
country: Greece
facility: Metropolitan General A E
city: Maroussi
country: Greece
facility: Athens Medical Center
city: Neo Faliro
country: Greece
facility: Metropolitan Hospital
city: Thessaloniki
country: Greece
facility: Bioclinic - Thessaloniki
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic
city: Thessaloniki
country: Greece
facility: Clinic Agios Loukas
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital Of Thessaloniki
city: Volos
country: Greece
facility: Anassa General Clinic
city: Budapest N/a
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Budapest
country: Hungary
facility: Eszak Pesti Centrumkorhaz Honvedkorhaz
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház és Rendelőintézet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
city: Amravati
country: India
facility: Sujan Surgical Cancer Hospital & Amravati Cancer Foundation
city: Bangalore
country: India
facility: Bangalore Medical College and Research Institute
city: Bikaner
country: India
facility: Acharya Tulsi Regional Cancer Treatment Research Institute
city: Nashik
country: India
facility: Shatabdi Super Speciality Hospital
city: New Delhi
country: India
facility: BLK Super Specialty Hospital
city: New Delhi
country: India
facility: Aakash Healthcare Super Speciality Hospital
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute & Research Centre
city: Patna
country: India
facility: Indira Gandhi Institute of Medical Sciences
city: Pune
country: India
facility: Jehangir Clinical Development Center Pvt Ltd
city: Arezzo
country: Italy
facility: Ospedale San Donato
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per I Oncologia IRCC Candiolo
city: Carpi
country: Italy
facility: Ospedale Civile Ramazzini
city: Catania
country: Italy
facility: Ospedale Cannizzaro
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
city: Genova
country: Italy
facility: SPDC Villa Scassi
city: Genova
country: Italy
facility: Ospedale San Martino
city: Lugo
country: Italy
facility: Ospedale Umberto I di Lugo
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Padova
country: Italy
facility: Istituto Oncologico Veneto - IRCCS
city: Pagani
country: Italy
facility: Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Pozzuoli
country: Italy
facility: ASL Napoli 2 Nord-SM delle Grazie Hospital
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant Andrea
city: Rome
country: Italy
facility: Universita Campus Bio-Medico di Roma
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Rozzano, IRCCS
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
city: Iizuka
country: Japan
facility: Aso Co.,Ltd Iizuka Hospital
city: Kanagawa
country: Japan
facility: St Marianna University Hospital
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
city: Kawagoe-Shi
country: Japan
facility: Saitama Medical University Hospital
city: Kisarazu-shi
country: Japan
facility: Kimitsu Chuo Hospital
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
city: Osaka
country: Japan
facility: JOHAS Osaka Rosai Hospital
city: Shunan
country: Japan
facility: Tokuyama Central Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Ube
country: Japan
facility: Yamaguchi University Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Gangnam Gu
country: Korea, Republic of
facility: Samsung Medical Center
city: Goyang si
country: Korea, Republic of
facility: National Cancer Center
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Namdong
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary s Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Yangsan Si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Ciudad de México
country: Mexico
facility: Oncologia Integral Satelite
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
city: Guadalajara
country: Mexico
facility: Consultorio Privado Dr Jose Arturo Rodriguez Rivera
city: Juchitan De Zaragoza
country: Mexico
facility: Centro De Estudio Y Prevencion Del Cancer
city: Leon
country: Mexico
facility: Dr. Marco Antonio Badillo Santoyo
city: Monterrey
country: Mexico
facility: i Can Oncology Center
city: Morelia
country: Mexico
facility: Centro de Investigacion Clinica Chapultepec
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C.
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
city: San Luis Potosi
country: Mexico
facility: Oncologico Potosino
city: Zapopan
country: Mexico
facility: Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V.
city: Siedlce
country: Poland
facility: Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Central
city: Lisboa
country: Portugal
facility: H. Santa Maria - Centro Hospitalar de Lisboa Norte
city: Lisbon
country: Portugal
facility: Fund. Champalimaud
city: Porto
country: Portugal
facility: Hospital de Sao Joao
city: Barnaul
country: Russian Federation
facility: Altlay Regional Oncology Dispensary
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Oncology Dispensary
city: Moscow
country: Russian Federation
facility: Hertzen Oncology Research Institute
city: Obninsk
country: Russian Federation
facility: A. Tsyb Medical Radiological Research Center
city: Omsk
country: Russian Federation
facility: BHI of Omsk region Clinical Oncology Dispensary
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University named after I.P.Pavlov
city: Saint Petersburg
country: Russian Federation
facility: N.N. Petrov Research Institute Of Oncology
city: Saransk
country: Russian Federation
facility: Ogarev Mordovian State University
city: Sochi
country: Russian Federation
facility: State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio
city: Tyumen
country: Russian Federation
facility: Multifunctional clinical medical center 'Medical city'
city: Ufa
country: Russian Federation
facility: Bashkir State Medical University
city: A Coruña
country: Spain
facility: Hosp Univ A Coruna
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Fund. Puigvert
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Granada
country: Spain
facility: Hosp. Univ. Virgen de Las Nieves
city: Jerez de la Frontera
country: Spain
facility: Hosp. de Jerez de La Frontera
city: Madrid
country: Spain
facility: Clinica Univ. de Navarra
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. de La Paz
city: Madrid
country: Spain
facility: Hosp Univ Hm Sanchinarro
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
city: Valencia
country: Spain
facility: Hosp. Clinico Univ. de Valencia
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou Branch
city: Adana
country: Turkey
facility: Adana Baskent Yuregir Hospital
city: Ankara
country: Turkey
facility: Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
city: Balcova
country: Turkey
facility: Dokuz Eylul Universitesi Tip Fakultesi
city: Fatih
country: Turkey
facility: Bezmialem University Medical Faculty
city: Gaziantep
country: Turkey
facility: Medical Park Gaziantep Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Goztepe Training and Research Hospital
city: Izmir
country: Turkey
facility: Izmir Medical Park Hospital
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty
city: Melikgazi
country: Turkey
facility: Erciyes Univ MKD Hospital
city: Seyhan
country: Turkey
facility: T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma Hastanesi
city: Chernihiv
country: Ukraine
facility: Chernihivskyi oblasnyi onkolohichnyi dyspanser
city: Dnipro
country: Ukraine
facility: SE Dnipropetrovsk Medical Academy
city: Kharkiv
country: Ukraine
facility: Kharkiv Regional Clinical Hospital
city: Kherson
country: Ukraine
facility: Khersonsky Regional Oncology Center
city: Kiev
country: Ukraine
facility: Asklepion LLC
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #3
city: Kyiv
country: Ukraine
facility: State Institution Academy Of Medical Sciences Of Ukraine
city: Kyiv
country: Ukraine
facility: P.L. Shupyk National Medical Academy of Post-Graduate Education
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trials
role: STUDY_DIRECTOR
References: