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)

Trial Title: 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)

NCT ID: NCT05714202

Condition: Bladder Cancer

Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: TAR-200
Description: TAR-200 will be administered intravesically.
Arm group label: Treatment Group A: TAR-200 + Cetrelimab
Arm group label: Treatment Group C: TAR-200 Alone

Other name: JNJ-17000139

Intervention type: Biological
Intervention name: Cetrelimab
Description: Cetrelimab will be administered.
Arm group label: Treatment Group A: TAR-200 + Cetrelimab

Other name: JNJ-63723283

Intervention type: Biological
Intervention name: BCG Vesiculture
Description: BCG will be administered intravesically.
Arm group label: Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic

Address:
City: Scottsdale
Zip: 85259
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Facility:
Name: Arkansas Urology

Address:
City: Little Rock
Zip: 72211
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Facility:
Name: VA Long Beach Health Care System

Address:
City: Long Beach
Zip: 90822
Country: United States

Facility:
Name: Genesis Research, LLC - West Coast Urology

Address:
City: Los Alamitos
Zip: 90720
Country: United States

Facility:
Name: Cedars Sinai Medical Center

Address:
City: Los Angeles
Zip: 90048
Country: United States

Facility:
Name: UC Davis Comprehensive Cancer Center

Address:
City: Sacramento
Zip: 95630
Country: United States

Facility:
Name: Genesis Research

Address:
City: San Diego
Zip: 92123
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Facility:
Name: Providence Saint Johns Cancer Institute

Address:
City: Santa Monica
Zip: 90404
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Facility:
Name: Providence Medical Foundation

Address:
City: Santa Rosa
Zip: 95403
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Facility:
Name: Colorado Clinical Research

Address:
City: Lakewood
Zip: 80228
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Facility:
Name: Urological Research Network

Address:
City: Hialeah
Zip: 33016
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Facility:
Name: Orlando Health Cancer Institute

Address:
City: Orlando
Zip: 32806
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Facility:
Name: Sarasota Memorial Hospital

Address:
City: Sarasota
Zip: 34239
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Facility:
Name: Grady Memorial Hospital

Address:
City: Atlanta
Zip: 30303
Country: United States

Facility:
Name: The Emory Clinic Department of Urology

Address:
City: Atlanta
Zip: 30322
Country: United States

Facility:
Name: Northwestern University

Address:
City: Chicago
Zip: 60611
Country: United States

Facility:
Name: Duly Health and Care

Address:
City: Lisle
Zip: 60532
Country: United States

Facility:
Name: Blessing Hospital

Address:
City: Quincy
Zip: 62301
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Facility:
Name: Urology of Indiana

Address:
City: Carmel
Zip: 46032
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Facility:
Name: First Urology

Address:
City: Jeffersonville
Zip: 47130
Country: United States

Facility:
Name: AMR Kansas City Oncology

Address:
City: Merriam
Zip: 66204
Country: United States

Facility:
Name: Wichita Urology Group

Address:
City: Wichita
Zip: 67226
Country: United States

Facility:
Name: Chesapeake Urology Research Associates

Address:
City: Hanover
Zip: 21076
Country: United States

Facility:
Name: Lahey Hospital & Medical Center

Address:
City: Burlington
Zip: 01805
Country: United States

Facility:
Name: University of Michigan

Address:
City: Ann Arbor
Zip: 48109
Country: United States

Facility:
Name: University Of Minnesota

Address:
City: Minneapolis
Zip: 55455
Country: United States

Facility:
Name: Mayo Clinic Rochester

Address:
City: Rochester
Zip: 55905
Country: United States

Facility:
Name: The Urology Center, PC

Address:
City: Omaha
Zip: 68114
Country: United States

Facility:
Name: Cooper Health System MD Anderson Cancer Center at Cooper

Address:
City: Camden
Zip: 08103
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Facility:
Name: VA NY Harbor Healthcare System

Address:
City: New York
Zip: 10010
Country: United States

Facility:
Name: Icahn School of Medicine at Mt. Sinai

Address:
City: New York
Zip: 10029
Country: United States

Facility:
Name: Associated Medical Professionals of Ny

Address:
City: Syracuse
Zip: 13210
Country: United States

Facility:
Name: SUNY Upstate Med Univ

Address:
City: Syracuse
Zip: 13210
Country: United States

Facility:
Name: Vidant Urology - Greenville

Address:
City: Greenville
Zip: 27834
Country: United States

Facility:
Name: Cleveland Clinic

Address:
City: Cleveland
Zip: 44195
Country: United States

Facility:
Name: Central Ohio Urology Group

Address:
City: Gahanna
Zip: 43230
Country: United States

Facility:
Name: Centers for Advanced Urology LLC d b a MidLantic Urology

Address:
City: Bala-Cynwyd
Zip: 19004
Country: United States

Facility:
Name: Thomas Jefferson University Hospital

Address:
City: Philadelphia
Zip: 19107
Country: United States

Facility:
Name: UPMC Shadyside Hospital

Address:
City: Pittsburgh
Zip: 15232
Country: United States

Facility:
Name: Carolina Urologic Research Center

Address:
City: Myrtle Beach
Zip: 29572
Country: United States

Facility:
Name: Urology Associates

Address:
City: Nashville
Zip: 37209
Country: United States

Facility:
Name: Vanderbilt University Medical Center

Address:
City: Nashville
Zip: 37232
Country: United States

Facility:
Name: Urology Austin

Address:
City: Austin
Zip: 78745
Country: United States

Facility:
Name: Urology Clinics of North Texas

Address:
City: Dallas
Zip: 75231
Country: United States

Facility:
Name: Houston Metro Urology

Address:
City: Houston
Zip: 77027
Country: United States

Facility:
Name: Houston Methodist Hospital

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: Urology San Antonio Research

Address:
City: San Antonio
Zip: 78229
Country: United States

Facility:
Name: Huntsman Cancer Institute

Address:
City: Salt Lake City
Zip: 84112
Country: United States

Facility:
Name: George E. Wahlen VAMC

Address:
City: Salt Lake City
Zip: 84148
Country: United States

Facility:
Name: Urology Of Virginia, Pllc

Address:
City: Virginia Beach
Zip: 23462
Country: United States

Facility:
Name: Spokane Urology

Address:
City: Spokane
Zip: 99202
Country: United States

Facility:
Name: Hospital Italiano de Buenos Aires

Address:
City: Buenos Aires
Zip: C1199
Country: Argentina

Facility:
Name: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

Address:
City: Buenos Aires
Zip: C1417
Country: Argentina

Facility:
Name: Centro Urologico Profesor Bengio

Address:
City: Cordoba
Zip: X5000KPH
Country: Argentina

Facility:
Name: Hospital Privado - Centro Medico de Cordoba

Address:
City: Cordoba
Zip: X5016KEH
Country: Argentina

Facility:
Name: Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Address:
City: Córdoba
Zip: 5000
Country: Argentina

Facility:
Name: Hospital Privado de la Comunidad

Address:
City: Mar del Plata
Zip: B7602CBM
Country: Argentina

Facility:
Name: Instituto Medico Rio Cuarto

Address:
City: Rio Cuarto
Zip: 5800
Country: Argentina

Facility:
Name: Austin Health

Address:
City: Heidelberg
Zip: 3084
Country: Australia

Facility:
Name: Macquarie University Hospital

Address:
City: Macquarie University
Zip: 2109
Country: Australia

Facility:
Name: Hollywood Private Hospital

Address:
City: Nedlands
Zip: 6009
Country: Australia

Facility:
Name: Mater Hospital Brisbane

Address:
City: South Brisbane
Zip: 4101
Country: Australia

Facility:
Name: ZNA Middelheim

Address:
City: Antwerpen
Zip: 2020
Country: Belgium

Facility:
Name: AZ Sint-Jan

Address:
City: Brugge
Zip: 8000
Country: Belgium

Facility:
Name: AZ Sint-Lucas

Address:
City: Brugge
Zip: 8310
Country: Belgium

Facility:
Name: AZ Maria Middelares

Address:
City: Gent
Zip: 9000
Country: Belgium

Facility:
Name: UZ Gent

Address:
City: Gent
Zip: 9000
Country: Belgium

Facility:
Name: Centre Hospitalier de l'Ardenne

Address:
City: Libramont-Chevigny
Zip: 6800
Country: Belgium

Facility:
Name: AZ Delta

Address:
City: Roeselare
Zip: 8800
Country: Belgium

Facility:
Name: Vitaz

Address:
City: Sint Niklaas
Zip: 9100
Country: Belgium

Facility:
Name: GZA Ziekenhuizen- Campus St Augustinus

Address:
City: Wilrijk
Zip: 2610
Country: Belgium

Facility:
Name: Fundacao Pio XII

Address:
City: Barretos
Zip: 14784-400
Country: Brazil

Facility:
Name: NAIC Nair Antunes Instituto do Cancer

Address:
City: Bauru
Zip: 17033-495
Country: Brazil

Facility:
Name: Universidade Estadual De Campinas

Address:
City: Campinas
Zip: 13083-888
Country: Brazil

Facility:
Name: Liga Paranaense de Combate ao Cancer

Address:
City: Curitiba
Zip: 81520 060
Country: Brazil

Facility:
Name: Liga Norte Riograndense Contra O Cancer

Address:
City: Natal
Zip: 59075-740
Country: Brazil

Facility:
Name: Irmandade Santa Casa de Misericordia de Porto Alegre

Address:
City: Porto Alegre
Zip: 90050-170
Country: Brazil

Facility:
Name: Hospital Regional do Cancer - Hospital de Esperança

Address:
City: Presidente Prudente
Zip: 19013-050
Country: Brazil

Facility:
Name: Hospital Sao Rafael

Address:
City: Salvador
Zip: 41253-190
Country: Brazil

Facility:
Name: Hospital Ana Nery Santa Cruz do Sul

Address:
City: Santa Cruz Do Sul
Zip: 96835-090
Country: Brazil

Facility:
Name: CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

Address:
City: Santo Andre
Zip: 09060-870
Country: Brazil

Facility:
Name: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

Address:
City: Sao Paulo
Zip: 01246 000
Country: Brazil

Facility:
Name: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

Address:
City: Sao Paulo
Zip: 05652 900
Country: Brazil

Facility:
Name: Real e Benemerita Associacao Portuguesa de Beneficencia

Address:
City: Sao Paulo
Zip: 1321 001
Country: Brazil

Facility:
Name: Fundacao Antonio Prudente A C Camargo Cancer Center

Address:
City: São Paulo
Zip: 01508-010
Country: Brazil

Facility:
Name: Nova Scotia Health Authority

Address:
City: Halifax
Zip: B3H 2Y9
Country: Canada

Facility:
Name: St Josephs Healthcare Hamilton

Address:
City: Hamilton
Zip: L8N 4A6
Country: Canada

Facility:
Name: Princess Margaret Cancer Centre University Health Network

Address:
City: Toronto
Zip: M5G 1Z5
Country: Canada

Facility:
Name: CHUM - Centre hospitalier universitaire de Montreal

Address:
City: Montréal
Zip: H2X 3E4
Country: Canada

Facility:
Name: Unite de Recherche Clinique du CISSS des Laurentides

Address:
City: Saint Jerome Quebec
Zip: J7Z 2V4
Country: Canada

Facility:
Name: CHU de Quebec Universite Laval Hopital de l Enfant Jesus

Address:
City: Quebec
Zip: G1J1Z4
Country: Canada

Facility:
Name: Peking University First Hospital

Address:
City: Beijing
Zip: 100034
Country: China

Facility:
Name: Beijing Hospital

Address:
City: Beijing
Zip: 100730
Country: China

Facility:
Name: Beijing Luhe Hospital, Capital Medical University

Address:
City: Beijing
Zip: 101100
Country: China

Facility:
Name: Hunan Province Cancer Hospital

Address:
City: Chang Sha
Zip: 410013
Country: China

Facility:
Name: The First Bethune Hospital of Jilin University

Address:
City: Changchun
Zip: 130499
Country: China

Facility:
Name: West China Hospital Sichuan University

Address:
City: Chengdu
Zip: 610044
Country: China

Facility:
Name: Chongqing University Cancer Hospital

Address:
City: Chongqing
Zip: 400000
Country: China

Facility:
Name: People's Hospital of Deyang City

Address:
City: Deyang City
Zip: 618000
Country: China

Facility:
Name: Sun Yat-Sen University Cancer Center

Address:
City: GuangZhou
Zip: 430030
Country: China

Facility:
Name: Zhejiang Provincial People's Hospital

Address:
City: Hangzhou
Zip: 310000
Country: China

Facility:
Name: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Address:
City: Hangzhou
Zip: 310016
Country: China

Facility:
Name: Nanjing Drum Tower Hospital

Address:
City: Nanjing
Zip: 210008
Country: China

Facility:
Name: The First Affiliated Hospital of Ningbo University

Address:
City: Ningbo
Zip: 315010
Country: China

Facility:
Name: Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine

Address:
City: Shanghai
Zip: 200025
Country: China

Facility:
Name: Huadong Hospital Affiliated to Fudan University

Address:
City: Shanghai
Zip: 200400
Country: China

Facility:
Name: Shengjing Hospital Of China Medical University

Address:
City: Shenyang
Zip: 110004
Country: China

Facility:
Name: The Second Hospital Of Tianjin Medical University

Address:
City: Tianjin
Zip: 300211
Country: China

Facility:
Name: The First Affiliated Hospital of Wenzhou Medical University

Address:
City: Wenzhou
Zip: 325000
Country: China

Facility:
Name: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

Address:
City: Wuhan
Zip: 430030
Country: China

Facility:
Name: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Address:
City: Xian
Zip: 710061
Country: China

Facility:
Name: Yantai Yuhuangding Hospital

Address:
City: Yantai
Zip: 264000
Country: China

Facility:
Name: Henan Cancer Hospital

Address:
City: Zhengzhou
Zip: 450008
Country: China

Facility:
Name: Fakultni nemocnice u sv. Anny v Brne

Address:
City: Brno
Zip: 65691
Country: Czechia

Facility:
Name: Fakultni nemocnice Hradec Kralove

Address:
City: Hradec Králové
Zip: 500 05
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Facility:
Name: Krajská nemocnice Liberec a.s.

Address:
City: Liberec
Zip: 460 01
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Facility:
Name: Fakultni nemocnice Olomouc

Address:
City: Olomouc
Zip: 779 00
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Facility:
Name: Fakultni nemocnice v Motole

Address:
City: Prague
Zip: 15006
Country: Czechia

Facility:
Name: Thomayerova nemocnice, Onkologicka klinika

Address:
City: Praha 4
Zip: 140 59
Country: Czechia

Facility:
Name: Fakultni nemocnice Kralovske Vinohrady

Address:
City: Praha
Zip: 100 34
Country: Czechia

Facility:
Name: Polyclinique Bordeaux Nord Acquitaine

Address:
City: Bordeaux
Zip: 33000
Country: France

Facility:
Name: CHU Gabriel-Montpied

Address:
City: Clermont-Ferrand
Zip: 63003
Country: France

Facility:
Name: CHU Grenoble

Address:
City: Grenoble
Zip: 38043
Country: France

Facility:
Name: Polyclinique de Limoges - Francois Chenieux

Address:
City: Limoges
Zip: 87000
Country: France

Facility:
Name: Hôpital Edouard Herriot

Address:
City: Lyon
Zip: 69437
Country: France

Facility:
Name: CHU de Nantes hotel Dieu

Address:
City: Nantes
Zip: 44093
Country: France

Facility:
Name: CHU Nîmes

Address:
City: Nimes
Zip: 30029
Country: France

Facility:
Name: Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source

Address:
City: Orléans
Zip: 45067
Country: France

Facility:
Name: Groupe Hospitalier Diaconesses Croix Saint Simon

Address:
City: PARIS cedex 20
Zip: 75960
Country: France

Facility:
Name: Hôpital Universitaire Pitié-Salpêtrière

Address:
City: Paris
Zip: 75013
Country: France

Facility:
Name: Hopital Europeen Georges-Pompidou

Address:
City: Paris
Zip: 75015
Country: France

Facility:
Name: APHP - Hopital Bichat - Claude Bernard

Address:
City: Paris
Zip: 75018
Country: France

Facility:
Name: Clinical La Croix Du Sud - Ramsay Santé

Address:
City: Quint-Fonsegrives
Zip: 31130
Country: France

Facility:
Name: Chu Rennes Hopital Pontchaillou

Address:
City: Rennes
Zip: 35000
Country: France

Facility:
Name: Institut de Cancerologie Strasbourg Europe ICANS

Address:
City: Strasbourg
Zip: 67200
Country: France

Facility:
Name: CHU Rangueil

Address:
City: Toulouse
Zip: 31059
Country: France

Facility:
Name: Urologicum Duisburg

Address:
City: Duisburg
Zip: 47169
Country: Germany

Facility:
Name: Universitatsklinikum Erlangen

Address:
City: Erlangen
Zip: 91054
Country: Germany

Facility:
Name: Universitatsklinikum Essen

Address:
City: Essen
Zip: 45147
Country: Germany

Facility:
Name: Universitaetsklinikum Frankfurt

Address:
City: Frankfurt am Main
Zip: 60590
Country: Germany

Facility:
Name: Universitaetsklinikum Freiburg

Address:
City: Freiburg
Zip: 79106
Country: Germany

Facility:
Name: Urologische Partnerschaft Koln UPK

Address:
City: Köln
Zip: 50968
Country: Germany

Facility:
Name: Matthias Schulze - Germany

Address:
City: Markkleeberg
Zip: 04416
Country: Germany

Facility:
Name: Urologie Neandertal Praxis Mettmann

Address:
City: Mettmann
Zip: 40822
Country: Germany

Facility:
Name: Universitatsklinikum Munster

Address:
City: Muenster
Zip: 48149
Country: Germany

Facility:
Name: Klinikum rechts der Isar an der Technischen Universitat Munchen

Address:
City: München
Zip: 81675
Country: Germany

Facility:
Name: Klinikum Nurnberg Nord

Address:
City: Nuernberg
Zip: 90419
Country: Germany

Facility:
Name: Medizinisches Versorgungszentrum - Urologie

Address:
City: Nurnberg
Zip: 90491
Country: Germany

Facility:
Name: Studienpraxis Urologie Nurtingen

Address:
City: Nürtingen
Zip: 72622
Country: Germany

Facility:
Name: Caritas-Krankenhaus St. Josef

Address:
City: Regensburg
Zip: 93053
Country: Germany

Facility:
Name: Universitat Tubingen

Address:
City: Tübingen
Zip: 72076
Country: Germany

Facility:
Name: Health Care Global Enterprises pvt Ltd

Address:
City: Bangalore
Zip: 560027
Country: India

Facility:
Name: Post Graduate Institute of Medical Education And Research PGIMER

Address:
City: Chandigarh
Zip: 160012
Country: India

Facility:
Name: Artemis Hospital

Address:
City: Gurugram
Zip: 122001
Country: India

Facility:
Name: Netaji Subhas chandra Bose Cancer Research Institute

Address:
City: Kolkata
Zip: 700094
Country: India

Facility:
Name: Tata Memorial Hospital

Address:
City: Mumbai
Zip: 400012
Country: India

Facility:
Name: CIMET s Inamdar Multispeciality Hospital

Address:
City: Pune
Zip: 411040
Country: India

Facility:
Name: Generale Regionale F. Miulli

Address:
City: Acquaviva delle Fonti
Zip: 70021
Country: Italy

Facility:
Name: Ospedale Cardinal Massaia

Address:
City: Asti
Zip: 14100
Country: Italy

Facility:
Name: Ospedale San Giuseppe Moscati di Avellino

Address:
City: Avellino
Zip: 83100
Country: Italy

Facility:
Name: Ospedale San Giacomo Apostolo, Guardia pediatrica territoriale

Address:
City: Castelfranco Veneto
Zip: 31033
Country: Italy

Facility:
Name: Ospedale San Raffaele di Milano

Address:
City: Milano
Zip: 20132
Country: Italy

Facility:
Name: Istituto Europeo di Oncologia

Address:
City: Milano
Zip: 20141
Country: Italy

Facility:
Name: Fondazione G Pascale Istituto Nazionale Tumori IRCCS

Address:
City: Napoli
Zip: 80138
Country: Italy

Facility:
Name: Ospedale S. Maria Delle Croci

Address:
City: Ravenna
Zip: 48121
Country: Italy

Facility:
Name: Istituto Nazionale Tumori Regina Elena

Address:
City: Rome
Zip: 00128
Country: Italy

Facility:
Name: Fuji City General Hospital

Address:
City: Fuji-shi
Zip: 417-8567
Country: Japan

Facility:
Name: Kanazawa University Hospital

Address:
City: Kanazawa
Zip: 920-8641
Country: Japan

Facility:
Name: Nara Medical University Hospital

Address:
City: Kashihara-shi
Zip: 634-8522
Country: Japan

Facility:
Name: Kimitsu Chuo Hospital

Address:
City: Kisarazu-shi
Zip: 292-8535
Country: Japan

Facility:
Name: Kobe City Medical Center General Hospital

Address:
City: Kobe City
Zip: 650 0047
Country: Japan

Facility:
Name: National Hospital Organization Kumamoto Medical Center

Address:
City: Kumamoto-shi
Zip: 860-0008
Country: Japan

Facility:
Name: Nagano Municipal Hospital

Address:
City: Nagano-shi
Zip: 381-8551
Country: Japan

Facility:
Name: Nagasaki University Hospital

Address:
City: Nagasaki-shi
Zip: 852-8501
Country: Japan

Facility:
Name: JRC Nagasaki Genbaku Hospital

Address:
City: Nagasaki-Shi
Zip: 852-8511
Country: Japan

Facility:
Name: Saiseikai Narashino Hospital

Address:
City: Narashino-shi
Zip: 275-8580
Country: Japan

Facility:
Name: Ehime University Hospital

Address:
City: Toon-shi
Zip: 791-0295
Country: Japan

Facility:
Name: Toyama University Hospital

Address:
City: Toyama-shi
Zip: 930-0194
Country: Japan

Facility:
Name: Yamaguchi University Hospital

Address:
City: Ube
Zip: 755-8505
Country: Japan

Facility:
Name: Yokohama City University Medical Center

Address:
City: Yokohama
Zip: 232 0024
Country: Japan

Facility:
Name: Pusan National University Hospital

Address:
City: Busan
Zip: 49241
Country: Korea, Republic of

Facility:
Name: Chungbuk National University Hospital

Address:
City: Cheongju
Zip: 28644
Country: Korea, Republic of

Facility:
Name: Kyungpook National University Chilgok Hospital

Address:
City: Daegu
Zip: 41404
Country: Korea, Republic of

Facility:
Name: Keimyung University Dongsan Hospital

Address:
City: Daegu
Zip: 42601
Country: Korea, Republic of

Facility:
Name: National Cancer Center

Address:
City: Gyeonggi-do
Zip: 10408
Country: Korea, Republic of

Facility:
Name: Chonnam National University Hwasun Hospital

Address:
City: Jeollanam-do
Zip: 58128
Country: Korea, Republic of

Facility:
Name: Korea University Anam Hospital

Address:
City: Seoul
Zip: 02841
Country: Korea, Republic of

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Facility:
Name: Kangbuk Samsung Hospital

Address:
City: Seoul
Zip: 03181
Country: Korea, Republic of

Facility:
Name: Severance Hospital Yonsei University Health System

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea Seoul St Marys Hospital

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Facility:
Name: Consultorio Medico dentro del Hospital Angeles Acoxpa

Address:
City: Ciudad de México
Zip: 14308
Country: Mexico

Facility:
Name: Hospital Universitario Dr Jose Eleuterio Gonzalez

Address:
City: Monterrey
Zip: 64460
Country: Mexico

Facility:
Name: Avix Investigacion Clinica S C

Address:
City: Monterrey
Zip: 64710
Country: Mexico

Facility:
Name: Eme Red Hospitalaria

Address:
City: Mérida
Zip: 97000
Country: Mexico

Facility:
Name: Oncologico Potosino

Address:
City: San Luis Potosí
Zip: 78260
Country: Mexico

Facility:
Name: Spaarne Ziekenhuis

Address:
City: Hoofddorp
Zip: 2134 TM
Country: Netherlands

Facility:
Name: Canisius-Wilhelmina Ziekenhuis

Address:
City: Nijmegen
Zip: 6524 KD
Country: Netherlands

Facility:
Name: Radboud Umcn

Address:
City: Nijmegen
Zip: 6525 GA
Country: Netherlands

Facility:
Name: Uniwersytecki Szpital Kliniczny w Bialymstoku

Address:
City: Bialystok
Zip: 15-276
Country: Poland

Facility:
Name: IN VIVO Sp. z o.o

Address:
City: Bydgoszcz
Zip: 85-048
Country: Poland

Facility:
Name: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

Address:
City: Lublin
Zip: 20-708
Country: Poland

Facility:
Name: Centrum Medyczne

Address:
City: Piotrkow Trybunalski
Zip: 97-300
Country: Poland

Facility:
Name: Clinical Research Center sp z o o MEDIC R s k

Address:
City: Poznan
Zip: 61 731
Country: Poland

Facility:
Name: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,

Address:
City: Slupsk
Zip: 76-200
Country: Poland

Facility:
Name: Provita Poliklinika

Address:
City: Warszawa
Zip: 02-647
Country: Poland

Facility:
Name: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Facility:
Name: Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Address:
City: Wroclaw
Zip: 50-556
Country: Poland

Facility:
Name: Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE

Address:
City: Coimbra
Zip: 3000-075
Country: Portugal

Facility:
Name: Centro Hospitalar de Lisboa Norte Hospital Santa Maria

Address:
City: Lisboa
Zip: 1649 028
Country: Portugal

Facility:
Name: Centro Hospitalar de Vila Nova de Gaia Espinho E P E

Address:
City: Vila Nova de Gaia
Zip: 4434 502
Country: Portugal

Facility:
Name: Hosp Univ A Coruna

Address:
City: A Coruña
Zip: 15006
Country: Spain

Facility:
Name: Hosp. Punta de Europa

Address:
City: Algeciras
Zip: 11207
Country: Spain

Facility:
Name: Fund. Puigvert

Address:
City: Barcelona
Zip: 08025
Country: Spain

Facility:
Name: Hosp. Gral. Univ. de Castellon

Address:
City: Castellon
Zip: 12004
Country: Spain

Facility:
Name: Hosp. Puerta Del Mar

Address:
City: Cádiz
Zip: 11009
Country: Spain

Facility:
Name: Hosp. Univ. de Bellvitge

Address:
City: L'Hospitalet de Llobregat
Zip: 08907
Country: Spain

Facility:
Name: Hosp. Univ. Lucus Augusti

Address:
City: Lugo
Zip: 27003
Country: Spain

Facility:
Name: Clinica Univ. de Navarra

Address:
City: Madrid
Zip: 28027
Country: Spain

Facility:
Name: Hosp. Univ. 12 de Octubre

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: Hosp. Univ. La Paz

Address:
City: Madrid
Zip: 28046
Country: Spain

Facility:
Name: Hosp Virgen de La Victoria

Address:
City: Málaga
Zip: 29010
Country: Spain

Facility:
Name: Hosp. Univ. Marques de Valdecilla

Address:
City: Santander
Zip: 39008
Country: Spain

Facility:
Name: Hosp. Clinico Univ. de Valencia

Address:
City: Valencia
Zip: 46010
Country: Spain

Facility:
Name: Kaohsiung Medical University Chung Ho Memorial Hospital

Address:
City: Kaohsiung City
Zip: 807
Country: Taiwan

Facility:
Name: Chang Kung Memorial Hospital

Address:
City: Kaohsiung
Zip: 833
Country: Taiwan

Facility:
Name: China Medical University Hospital

Address:
City: Taichung City
Zip: 404
Country: Taiwan

Facility:
Name: Taichung Veterans General Hospital

Address:
City: Taichung
Zip: 40705
Country: Taiwan

Facility:
Name: Taipei Veterans General Hospital

Address:
City: Taipei
Zip: 11217
Country: Taiwan

Facility:
Name: Linkou Chang Gung Memorial Hospital

Address:
City: Taoyuan
Zip: 33382
Country: Taiwan

Facility:
Name: Western General Hospital

Address:
City: Edinburgh
Zip: EH4 2XU
Country: United Kingdom

Facility:
Name: St Bartholomews Hospital

Address:
City: London
Zip: EC1A 7BE
Country: United Kingdom

Facility:
Name: The Royal Marsden NHS Trust

Address:
City: London
Zip: SW3 6JJ
Country: United Kingdom

Facility:
Name: Charing Cross Hospital

Address:
City: London
Zip: W6 8RF
Country: United Kingdom

Facility:
Name: Derriford Hospital

Address:
City: Plymouth
Zip: PL6 8DH
Country: United Kingdom

Facility:
Name: Scunthorpe General Hospital

Address:
City: Scunthorpe
Zip: DN15 7BH
Country: United Kingdom

Facility:
Name: Sheffield Teaching Hospitals NHS Foundation Trust

Address:
City: Sheffield
Zip: S10 2JF
Country: United Kingdom

Facility:
Name: Lister Hospital

Address:
City: Stevenage
Zip: SG1 4AB
Country: United Kingdom

Facility:
Name: Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

Address:
City: Truro
Zip: TR1 3LJ
Country: United Kingdom

Start date: March 23, 2023

Completion date: September 18, 2029

Lead sponsor:
Agency: Janssen Research & Development, LLC
Agency class: Industry

Source: Janssen Research & Development, LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05714202