Clinical trial NCT05714202: A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)
Official title: A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Bladder Cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-02-06
Enrollment: 1135
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 this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

Detailed description: Bladder cancer is the tenth most common malignancy worldwide. About 75 percent (%) of bladder cancers are non-muscle invasive at diagnosis with approximately 25% of NMIBC patients have HR, NMIBC. The TAR-200/gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The mainstay of treatment for HR-NMIBC is transurethral resection of bladder tumor, followed by intravesical treatment with BCG. In this study metronomic dosing of intravesical gemcitabine, delivered via TAR-200, alone or in combination with cetrelimab will be evaluated and compared against intravesical BCG. The study consists of a Screening phase, Treatment phase, and Follow-up phase. The total duration of the study will be up to 5 years and 2 months. Efficacy, Safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during the study.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed initial diagnosis by local pathology (within 90 days of the most recent signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ \[CIS\]), in participants who are Bacillus Calmette Guérin (BCG)-naïve
* BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible)
* All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma \[HGUC\]) for patients with papillary only disease (without CIS)
* Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
* 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 date of randomization
* Participants must be willing to undergo all study procedures

Exclusion Criteria:

* Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to \[\>=\] T2)
* Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis). Ta/any T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization
* Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-200 or administration of intravesical BCG. Participants with tumors involving the prostatic urethra in men will be excluded
* A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (mL)
* Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

Primary outcomes:
measure: Event-free Survival (EFS)
timeFrame: Up to 5 years 2 months
Secondary outcomes:
measure: Overall Complete Response (CR) Rate
timeFrame: Up to 5 years 2 months
measure: Duration of CR
timeFrame: Up to 5 years 2 months
measure: Recurrence-Free Survival (RFS)
timeFrame: Up to 5 years 2 months
measure: Time to Progression (TTP)
timeFrame: Up to 5 years 2 months
measure: Overall Survival (OS)
timeFrame: Up to 5 years 2 months
measure: Cancer Specific Survival (CSS)
timeFrame: Up to 5 years 2 months
measure: Number of Participants with Adverse Events (AEs) by Grades According to Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: Up to 5 years 2 months
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 5 years 2 months
measure: Number of Participants with Change from Baseline in Laboratory Abnormalities
timeFrame: Up to 5 years 2 months
measure: Number of Participants with Change from Baseline in Vital Signs Abnormalities
timeFrame: Up to 5 years 2 months
measure: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - Non-muscle Invasive Bladder Cancer EORTC QLQ- NMIBC 24
timeFrame: Up to 5 years 2 months
measure: Time to Symptom Deterioration as Assessed by EORTC-QLQ-NMIBC 24 Scores
timeFrame: Up to 5 years 2 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Long Beach
country: United States
facility: VA Long Beach Health Care System
state: California
city: Los Alamitos
country: United States
facility: Genesis Research, LLC - West Coast Urology
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: San Diego
country: United States
facility: Genesis Research
state: California
city: Santa Monica
country: United States
facility: Providence Saint Johns Cancer Institute
state: California
city: Santa Rosa
country: United States
facility: Providence Medical Foundation
state: California
city: Lakewood
country: United States
facility: Colorado Clinical Research
state: Colorado
city: Hialeah
country: United States
facility: Urological Research Network
state: Florida
city: Orlando
country: United States
facility: Orlando Health Cancer Institute
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic Department of Urology
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Lisle
country: United States
facility: Duly Health and Care
state: Illinois
city: Quincy
country: United States
facility: Blessing Hospital
state: Illinois
city: Carmel
country: United States
facility: Urology of Indiana
state: Indiana
city: Jeffersonville
country: United States
facility: First Urology
state: Indiana
city: Merriam
country: United States
facility: AMR Kansas City Oncology
state: Kansas
city: Wichita
country: United States
facility: Wichita Urology Group
state: Kansas
city: Hanover
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University Of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Omaha
country: United States
facility: The Urology Center, PC
state: Nebraska
city: Camden
country: United States
facility: Cooper Health System MD Anderson Cancer Center at Cooper
state: New Jersey
city: New York
country: United States
facility: VA NY Harbor Healthcare System
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of Ny
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Med Univ
state: New York
city: Greenville
country: United States
facility: Vidant Urology - Greenville
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Gahanna
country: United States
facility: Central Ohio Urology Group
state: Ohio
city: Bala-Cynwyd
country: United States
facility: Centers for Advanced Urology LLC d b a MidLantic Urology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside Hospital
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Urology Austin
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Salt Lake City
country: United States
facility: George E. Wahlen VAMC
state: Utah
city: Virginia Beach
country: United States
facility: Urology Of Virginia, Pllc
state: Virginia
city: Spokane
country: United States
facility: Spokane Urology
state: Washington
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes
city: Cordoba
country: Argentina
facility: Centro Urologico Profesor Bengio
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba
city: Córdoba
country: Argentina
facility: Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
city: Mar del Plata
country: Argentina
facility: Hospital Privado de la Comunidad
city: Rio Cuarto
country: Argentina
facility: Instituto Medico Rio Cuarto
city: Heidelberg
country: Australia
facility: Austin Health
city: Macquarie University
country: Australia
facility: Macquarie University Hospital
city: Nedlands
country: Australia
facility: Hollywood Private Hospital
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Brugge
country: Belgium
facility: AZ Sint-Lucas
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: UZ Gent
city: Libramont-Chevigny
country: Belgium
facility: Centre Hospitalier de l'Ardenne
city: Roeselare
country: Belgium
facility: AZ Delta
city: Sint Niklaas
country: Belgium
facility: Vitaz
city: Wilrijk
country: Belgium
facility: GZA Ziekenhuizen- Campus St Augustinus
city: Barretos
country: Brazil
facility: Fundacao Pio XII
city: Bauru
country: Brazil
facility: NAIC Nair Antunes Instituto do Cancer
city: Campinas
country: Brazil
facility: Universidade Estadual De Campinas
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Presidente Prudente
country: Brazil
facility: Hospital Regional do Cancer - Hospital de Esperança
city: Salvador
country: Brazil
facility: Hospital Sao Rafael
city: Santa Cruz Do Sul
country: Brazil
facility: Hospital Ana Nery Santa Cruz do Sul
city: Santo Andre
country: Brazil
facility: CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
city: Sao Paulo
country: Brazil
facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
city: Sao Paulo
country: Brazil
facility: Real e Benemerita Associacao Portuguesa de Beneficencia
city: São Paulo
country: Brazil
facility: Fundacao Antonio Prudente A C Camargo Cancer Center
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: St Josephs Healthcare Hamilton
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre University Health Network
state: Ontario
city: Montréal
country: Canada
facility: CHUM - Centre hospitalier universitaire de Montreal
state: Quebec
city: Saint Jerome Quebec
country: Canada
facility: Unite de Recherche Clinique du CISSS des Laurentides
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec Universite Laval Hopital de l Enfant Jesus
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
city: Chang Sha
country: China
facility: Hunan Province Cancer Hospital
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Deyang City
country: China
facility: People's Hospital of Deyang City
city: GuangZhou
country: China
facility: Sun Yat Sen University Cancer Center
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
city: Shanghai
country: China
facility: Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Tianjin
country: China
facility: The Second Hospital Of Tianjin Medical University
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
city: Xian
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Hradec Králové
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Liberec
country: Czechia
facility: Krajská nemocnice Liberec a.s.
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Prague
country: Czechia
facility: Fakultni nemocnice v Motole
city: Praha 4
country: Czechia
facility: Thomayerova nemocnice, Onkologicka klinika
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Acquitaine
city: Clermont-Ferrand
country: France
facility: CHU Gabriel-Montpied
city: Grenoble
country: France
facility: CHU Grenoble
city: Limoges
country: France
facility: Polyclinique de Limoges - Francois Chenieux
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Nantes
country: France
facility: CHU de Nantes hotel Dieu
city: Nimes
country: France
facility: CHU Nimes
city: Orléans
country: France
facility: Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
city: PARIS cedex 20
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint Simon
city: Paris
country: France
facility: Hôpital Universitaire Pitié-Salpêtrière
city: Paris
country: France
facility: Hopital Europeen Georges-Pompidou
city: Paris
country: France
facility: APHP - Hopital Bichat - Claude Bernard
city: Quint-Fonsegrives
country: France
facility: Clinical La Croix Du Sud - Ramsay Santé
city: Rennes
country: France
facility: Chu Rennes Hopital Pontchaillou
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe ICANS
city: Toulouse
country: France
facility: CHU Rangueil
city: Duisburg
country: Germany
facility: Urologicum Duisburg
city: Erlangen
country: Germany
facility: Universitatsklinikum Erlangen
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Köln
country: Germany
facility: Urologische Partnerschaft Koln UPK
city: Markkleeberg
country: Germany
facility: Matthias Schulze - Germany
city: Mettmann
country: Germany
facility: Urologie Neandertal Praxis Mettmann
city: Muenster
country: Germany
facility: Universitatsklinikum Munster
city: München
country: Germany
facility: Klinikum rechts der Isar an der Technischen Universitat Munchen
city: Nuernberg
country: Germany
facility: Klinikum Nurnberg Nord
city: Nurnberg
country: Germany
facility: Medizinisches Versorgungszentrum - Urologie
city: Nürtingen
country: Germany
facility: Studienpraxis Urologie Nurtingen
city: Regensburg
country: Germany
facility: Caritas-Krankenhaus St. Josef
city: Tübingen
country: Germany
facility: Universitat Tubingen
city: Bangalore
country: India
facility: Health Care Global Enterprises pvt Ltd
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education And Research PGIMER
city: Gurugram
country: India
facility: Artemis Hospital
city: Kolkata
country: India
facility: Netaji Subhas chandra Bose Cancer Research Institute
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: Pune
country: India
facility: CIMET s Inamdar Multispeciality Hospital
city: Acquaviva delle Fonti
country: Italy
facility: Generale Regionale F. Miulli
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia
city: Avellino
country: Italy
facility: Ospedale San Giuseppe Moscati di Avellino
city: Castelfranco Veneto
country: Italy
facility: Ospedale San Giacomo Apostolo, Guardia pediatrica territoriale
city: Milano
country: Italy
facility: Ospedale San Raffaele di Milano
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Napoli
country: Italy
facility: Fondazione G Pascale Istituto Nazionale Tumori IRCCS
city: Ravenna
country: Italy
facility: Ospedale S. Maria Delle Croci
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Fuji-shi
country: Japan
facility: Fuji City General Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kashihara-shi
country: Japan
facility: Nara Medical University Hospital
city: Kisarazu-shi
country: Japan
facility: Kimitsu Chuo Hospital
city: Kobe City
country: Japan
facility: Kobe City Medical Center General Hospital
city: Kumamoto shi
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Nagano-shi
country: Japan
facility: Nagano Municipal Hospital
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
city: Nagasaki-Shi
country: Japan
facility: JRC Nagasaki Genbaku Hospital
city: Narashino-shi
country: Japan
facility: Saiseikai Narashino Hospital
city: Toon-shi
country: Japan
facility: Ehime University Hospital
city: Toyama-shi
country: Japan
facility: Toyama 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: Pusan National University Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University 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: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Ciudad de México
country: Mexico
facility: Consultorio Medico dentro del Hospital Angeles Acoxpa
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
city: Monterrey
country: Mexico
facility: Avix Investigacion Clinica S C
city: Mérida
country: Mexico
facility: Eme Red Hospitalaria
city: San Luis Potosí
country: Mexico
facility: Oncologico Potosino
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud Umcn
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Bydgoszcz
country: Poland
facility: IN VIVO Sp. z o.o
city: Lublin
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
city: Piotrkow Trybunalski
country: Poland
facility: Centrum Medyczne
city: Poznan
country: Poland
facility: Clinical Research Center sp z o o MEDIC R s k
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im Janusza Korczaka
city: Warszawa
country: Poland
facility: Provita Poliklinika
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
city: Coimbra
country: Portugal
facility: Ipo Coimbra
city: Lisboa
country: Portugal
facility: Uls Santa Maria - Hosp. Santa Maria
city: Vila Nova de Gaia
country: Portugal
facility: Uls Gaia Espinho
city: A Coruña
country: Spain
facility: Hosp Univ A Coruna
city: Algeciras
country: Spain
facility: Hosp. Punta de Europa
city: Barcelona
country: Spain
facility: Fund. Puigvert
city: Castellon
country: Spain
facility: Hosp. Gral. Univ. de Castellon
city: Cádiz
country: Spain
facility: Hosp. Puerta Del Mar
city: L'Hospitalet de Llobregat
country: Spain
facility: Hosp. Univ. de Bellvitge
city: Lugo
country: Spain
facility: Hosp. Univ. Lucus Augusti
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. La Paz
city: Málaga
country: Spain
facility: Hosp Virgen de La Victoria
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Valencia
country: Spain
facility: Hosp. Clinico Univ. de Valencia
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Kung Memorial Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: St Bartholomews Hospital
city: London
country: United Kingdom
facility: The Royal Marsden NHS Trust
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Scunthorpe
country: United Kingdom
facility: Scunthorpe General Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: Stevenage
country: United Kingdom
facility: Lister Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: