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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)

Primary Purpose

Urinary Bladder Neoplasms

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cetrelimab
TAR-200
Cisplatin
Gemcitabine
Conventional radiation therapy
Hypo-fractioned radiation therapy
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 within normal range or stable on hormone supplementation per investigator assessment. 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.

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

Sites / Locations

  • University of Southern CaliforniaRecruiting
  • Providence Saint John's Health CenterRecruiting
  • Stanford University Medical CenterRecruiting
  • The Urology Center of Colorado
  • Foothills Urology - Golden OffRecruiting
  • Winship Cancer Institute of Emory UniversityRecruiting
  • DuPage Medical GroupRecruiting
  • University Hospitals Seidman Cancer CenterRecruiting
  • Adult Pediatric Urology & Urogynecology, P.CRecruiting
  • New Jersey Urology LLC
  • Cardiology Clinic at Montefiore Hutchinson ComplexRecruiting
  • Duke University Medical CenterRecruiting
  • Vidant Urology - GreenvilleRecruiting
  • Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer CenterRecruiting
  • Stephenson Cancer CenterRecruiting
  • MidLantic UrologyRecruiting
  • Carolina Urologic Research CenterRecruiting
  • University of Tennessee Medical CenterRecruiting
  • University of Texas Medical BranchRecruiting
  • Virginia Oncology AssociatesRecruiting
  • Fundacion IntecnusRecruiting
  • Sociedade Beneficente de Senhoras - Hospital Sírio LibanêsRecruiting
  • Instituto Medico Especializado Alexander FlemingRecruiting
  • Hospital Italiano de Buenos AiresRecruiting
  • Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion ClinicaRecruiting
  • Centro Urologico Profesor BengioRecruiting
  • Sanatorio Allende CerroRecruiting
  • Centro Oncologico Riojano Integral (Cori)Recruiting
  • Centro de Investigacion Pergamino SARecruiting
  • CEDIC Centro de Investigaciones ClinicasRecruiting
  • Flinders Medical Centre
  • Krankenhaus der barmherzigen SchwesternRecruiting
  • Universitätsklinikum Salzburg - LandeskrankenhausRecruiting
  • Medizinische Universität WienRecruiting
  • Hopital ErasmeRecruiting
  • ZNA MiddelheimRecruiting
  • AZ Sint-LucasRecruiting
  • AZ Sint-Jan Brugge-Oostende AVRecruiting
  • Az Groeninge
  • Algemeen Ziekenhuis DeltaRecruiting
  • Fundacao Pio XIIRecruiting
  • Fundação Hospitalar São Francisco de AssisRecruiting
  • Liga Paranaense de Combate ao CancerRecruiting
  • Centro Regional Integrado de Oncologia - CRIO
  • Clinica de Oncologia ReichowRecruiting
  • Fundacao Doutor Amaral CarvalhoRecruiting
  • Liga Norte Riograndense Contra O CancerRecruiting
  • Hospital das Clinicas de Porto AlegreRecruiting
  • União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRSRecruiting
  • Hospital Regional do Câncer - Hospital de EsperançaRecruiting
  • Hospital Sao RafaelRecruiting
  • CEPHO - Centro de Estudos e Pesquisa de Hematologia e OncologiaRecruiting
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de BaseRecruiting
  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao PauloRecruiting
  • Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPERecruiting
  • Sociedade Beneficente de Senhoras - Hospital Sirio LibanesRecruiting
  • Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinRecruiting
  • Centro Oncológico do TriânguloRecruiting
  • McGill University Health CentreRecruiting
  • CHU de Québec -L'Hôtel-Dieu de QuébecRecruiting
  • Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)Recruiting
  • Peking University First HospitalRecruiting
  • Peking University Third HospitalRecruiting
  • Beijing HospitalRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • Hunan Cancer hospitalRecruiting
  • The Third Xiangya Hospital of Central Sourth UniversityRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • Chongqing University Cancer HospitalRecruiting
  • Guangzhou First Municipal People's HospitalRecruiting
  • Sun Yat-Sen University Cancer CenterRecruiting
  • Zhejiang Provincial People's HospitalRecruiting
  • The First Hospital of JiaxingRecruiting
  • Nanjing Drum Tower HospitalRecruiting
  • Qingdao Municipal HospitalRecruiting
  • Ruijin HospitalRecruiting
  • Renji HospitalRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • Tianjin Medical University Cancer Institute and HospitalRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • Wuhan Union HospitalRecruiting
  • Wuhan Tongji Hospital, Tongji Medical CollegeRecruiting
  • Yantai Yuhuangding HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • Slezska nemocnice v OpaveRecruiting
  • Fakultni nemocnice PlzeRecruiting
  • Urocentrum PrahaRecruiting
  • Vseobecna fakultni nemocnice v PrazeRecruiting
  • Thomayerova nemocnice
  • Fakultni nemocnice v MotoleRecruiting
  • Nemocnice Na BulovceRecruiting
  • Fakultni nemocnice Kralovske VinohradyRecruiting
  • ICH Hopital A. MorvanRecruiting
  • Pole Sante Leonard de VinciRecruiting
  • Clinique Sainte MargueriteRecruiting
  • CHRU Lille
  • Polyclinique de Limoges - Francois ChenieuxRecruiting
  • Hôpital Edouard HerriotRecruiting
  • Institut Paoli-CalmettesRecruiting
  • Hôpital EuropéenRecruiting
  • Institut Regional du Cancer de Montpellier
  • CHU NîmesRecruiting
  • Hopital Europeen Georges-PompidouRecruiting
  • Hôpital Bichat - Claude BernardRecruiting
  • Hôpital TenonRecruiting
  • Clinical La Croix Du Sud - Ramsay SantéRecruiting
  • Centre hospitalier universitaire de St EtienneRecruiting
  • Centre Hospitalier PriveRecruiting
  • Hopital FochRecruiting
  • Urologicum DuisburgRecruiting
  • Universitätsklinikum DüsseldorfRecruiting
  • Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus KrankenhausRecruiting
  • Universitatsklinikum FrankfurtRecruiting
  • Klinikum Herne - UrologieRecruiting
  • Matthias Schulze - GermanyRecruiting
  • Universitätsklinikum MünsterRecruiting
  • Klinikum Nürnberg Nord - HautklinikRecruiting
  • Alexandra General Hospital of AthensRecruiting
  • Metropolitan General A.E.Recruiting
  • Athens Medical CenterRecruiting
  • Metropolitan HospitalRecruiting
  • Bioclinic - ThessalonikiRecruiting
  • Euromedica General ClinicRecruiting
  • 'Papageorgiou' General Hospital of ThessalonikiRecruiting
  • Anassa General ClinicRecruiting
  • Orszagos Onkologiai IntezetRecruiting
  • Eszak-Pesti Centrumkorhaz - HonvedkorhazRecruiting
  • Bajcsy-Zsilinszky Kórház és RendelőintézetRecruiting
  • Debreceni Egyetem Klinikai Kozpont
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi OktatokorhazRecruiting
  • Sujan Surgical Cancer Hospital & Amravati Cancer FoundationRecruiting
  • Acharya Tulsi Regional Cancer Treatment Research InstituteRecruiting
  • Shatabdi Super Speciality HospitalRecruiting
  • BLK Super Specialty HospitalRecruiting
  • Aakash Healthcare Super Speciality HospitalRecruiting
  • Rajiv Gandhi Cancer Institute & Research CentreRecruiting
  • Indira Gandhi Institute of Medical SciencesRecruiting
  • Jehangir Clinical Development Center Pvt LtdRecruiting
  • Fondazione del Piemonte per I'Oncologia IRCC CandioloRecruiting
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di FoggiaRecruiting
  • SPDC Villa ScassiRecruiting
  • Ospedale San MartinoRecruiting
  • Istituto Europeo di OncologiaRecruiting
  • Ospedale San RaffaeleRecruiting
  • Azienda Ospedaliera Universitaria Federico IIRecruiting
  • Istituto Oncologico Veneto - IRCCSRecruiting
  • Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di PaganiRecruiting
  • Azienda Ospedaliero Universitaria PisanaRecruiting
  • ASL Napoli 2 Nord-SM delle Grazie HospitalRecruiting
  • Policlinico Universitario Agostino GemelliRecruiting
  • Azienda Ospedaliera Sant AndreaRecruiting
  • Universita Campus Bio-Medico di RomaRecruiting
  • Istituto Nazionale Tumori Regina ElenaRecruiting
  • Azienda Ospedaliera Universitaria Città della Salute e della Scienza di TorinoRecruiting
  • Ospedale di Circolo e Fondazione MacchiRecruiting
  • Ospedale San Bortolo
  • Aso Co.,Ltd Iizuka HospitalRecruiting
  • St.Marianna University HospitalRecruiting
  • Nara Medical University HospitalRecruiting
  • Saitama Medical University HospitalRecruiting
  • Kimitsu Chuo HospitalRecruiting
  • Nagasaki University HospitalRecruiting
  • JOHAS Osaka Rosai HospitalRecruiting
  • Tokuyama Central HospitalRecruiting
  • Toranomon HospitalRecruiting
  • Fujita Health University HospitalRecruiting
  • Yamaguchi University HospitalRecruiting
  • Yokohama City University Medical CenterRecruiting
  • Inje University Haeundae Paik HospitalRecruiting
  • Kyungpook National University Chilgok HospitalRecruiting
  • Keimyung University Dongsan HospitalRecruiting
  • National Cancer CenterRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Severance HospitalRecruiting
  • Gangnam Severance HospitalRecruiting
  • The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
  • Pusan National University Yangsan HospitalRecruiting
  • Oncologia Integral SateliteRecruiting
  • Consultorio Privado Dr Jose Arturo Rodriguez RiveraRecruiting
  • Centro De Estudio Y Prevencion Del CancerRecruiting
  • Dr. Marco Antonio Badillo SantoyoRecruiting
  • i Can Oncology CenterRecruiting
  • Centro de Investigacion Clinica ChapultepecRecruiting
  • Oncológico PotosinoRecruiting
  • Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V.Recruiting
  • Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
  • Centrum Medyczne Pratia Poznan
  • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Uniwersytecki Szpital KlinicznyRecruiting
  • Centro Hospitalar e Universitario de CoimbraRecruiting
  • H. Santa Maria - Centro Hospitalar de Lisboa NorteRecruiting
  • Fundação ChampalimaudRecruiting
  • Hospital de Sao JoaoRecruiting
  • Altlay Regional Oncology Dispensary
  • Ivanovo Regional Oncology Dispensary
  • Krasnoyarsk Regional Oncology Dispensary
  • Hertzen Oncology Research Institute
  • A. Tsyb Medical Radiological Research Center
  • BHI of Omsk region Clinical Oncology Dispensary
  • Ryazan State Medical University named after I.P.Pavlov
  • N.N. Petrov Research Institute Of Oncology
  • Ogarev Mordovian State University
  • State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio
  • Multifunctional clinical medical center 'Medical city'
  • Bashkir State Medical University
  • Hosp. Univ. A CoruñaRecruiting
  • Hosp. Univ. Virgen de Las NievesRecruiting
  • Hosp. de Jerez de La FronteraRecruiting
  • Clinica Univ. de NavarraRecruiting
  • Hosp. Univ. 12 de OctubreRecruiting
  • Hosp. Univ. de La PazRecruiting
  • Hosp. Univ. Hm SanchinarroRecruiting
  • Corporacio Sanitari Parc TauliRecruiting
  • Hosp. Univ. Marques de ValdecillaRecruiting
  • Instituto Valenciano de OncologiaRecruiting
  • Hosp. Clinico Univ. de ValenciaRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • China Medical University HospitalRecruiting
  • Taichung Veterans General HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Tri-Service General HospitalRecruiting
  • Chang Gung Memorial Hospital Linkou BranchRecruiting
  • Adana Baskent Yuregir HospitalRecruiting
  • Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training HospitalRecruiting
  • Ankara Universitesi Tip Fakultesi Cebeci HastanesiRecruiting
  • Dokuz Eylul Universitesi Tip FakultesiRecruiting
  • Bezmialem University Medical FacultyRecruiting
  • Medical Park Gaziantep HastanesiRecruiting
  • Istanbul Medeniyet University Goztepe Training and Research HospitalRecruiting
  • Izmir Medical Park HospitalRecruiting
  • Inonu University Medical FacultyRecruiting
  • Erciyes Univ MKD HospitalRecruiting
  • T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma HastanesiRecruiting
  • Chernihivskyi oblasnyi onkolohichnyi dyspanser
  • SE Dnipropetrovsk Medical Academy
  • Kharkiv Regional Clinical Hospital
  • Khersonsky Regional Oncology Center
  • Asklepion LLC
  • Kyiv City Clinical Hospital #3
  • State Institution Academy Of Medical Sciences Of Ukraine
  • P.L. Shupyk National Medical Academy of Post-Graduate Education
  • Lviv Regional Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAR-200 + Cetrelimab

Chemotherapy (cisplatin or gemcitabine) + Radiation Therapy

Arm Description

Participants 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.

Participants will receive chemotherapy based on investigator's choice from either cisplatin intravenously once weekly for 6 treatment weeks or gemcitabine intravenously twice weekly for 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Metastasis-free survival (MFS)
MFS is measured from time from randomization to first radiologic (as assessed by RECIST 1.1 criteria) or histologic evidence of metastatic disease or death due to any cause.
Overall Survival (OS)
OS is defined as time from randomization to death.
Overall Response Rate (ORR)
ORR is defined as proportion of participants who have complete response (CR) (defined as Negative biopsy, and Computed tomography/Magnetic resonance imaging [CT/MRI] of chest, abdomen, and pelvis showing no evidence of local recurrence, progression, or metastatic disease) or partial response (PR): (defined as down staging: biopsy proven non-muscle invasive disease less than [<] T1 and CT/MRI of chest, abdomen, and pelvis showing no evidence of metastatic disease) or non-response (those not achieving a complete response or down-staging, or those who do not undergo a biopsy will be considered non-responders).
Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)
Number of Participants with AEs by Severity as assessed by CTCAE version 5 will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.
Number of Participants with AEs by Severity according to Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)
NCI PRO-CTCAE is a patient-reported item library used to evaluate symptomatic treatment-emergent adverse events in participants on cancer clinical trials. The items selected for this study include all NCI PRO-CTCAE gastrointestinal items and urinary items. These items include taste changes, decreased appetite, nausea, vomiting, heartburn, gas, bloating, hiccups, constipation, diarrhea, abdominal pain, fecal incontinence, painful, urination, urinary urgency, urinary frequency, change in usual urine color, and urinary incontinence.
Number of Participants with Clinical Laboratory Abnormalities
Number of participants with clinical laboratory abnormalities will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

Full Information

First Posted
November 19, 2020
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04658862
Brief Title
A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
Acronym
SunRISe-2
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2020 (Actual)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The TAR-200 is an investigational intravesical drug delivery system. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed cell death protein 1 (PD-1). Study consists of screening phase of 42 days, treatment phase and follow up phase. The total duration of study will be up to 8 years. Efficacy evaluation includes disease assessment (Cystoscopy/TURBT Biopsy/Pathology) and Patient Reported Outcomes (Quality of Life Assessments) and safety assessments includes vital sign measurements, 12-lead electrocardiogram (ECG), physical examinations, clinical laboratory tests, cystoscopic examination, anti-drug antibody (ADA) assessments, concomitant treatments/procedures and adverse event monitoring.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAR-200 + Cetrelimab
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Chemotherapy (cisplatin or gemcitabine) + Radiation Therapy
Arm Type
Active Comparator
Arm Description
Participants will receive chemotherapy based on investigator's choice from either cisplatin intravenously once weekly for 6 treatment weeks or gemcitabine intravenously twice weekly for 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.
Intervention Type
Biological
Intervention Name(s)
Cetrelimab
Other Intervention Name(s)
JNJ-63723283
Intervention Description
Participants will receive intravenous Cetrelimab.
Intervention Type
Drug
Intervention Name(s)
TAR-200
Other Intervention Name(s)
JNJ-17000139
Intervention Description
Participants will receive intravesical TAR-200.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Participants will receive cisplatin intravenously.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Participants will receive gemcitabine intravenously.
Intervention Type
Radiation
Intervention Name(s)
Conventional radiation therapy
Intervention Description
Participants will receive conventional radiation therapy for bladder (64 gy).
Intervention Type
Radiation
Intervention Name(s)
Hypo-fractioned radiation therapy
Intervention Description
Participants will receive hypo-fractioned radiation therapy for bladder (55 gy).
Primary Outcome Measure Information:
Title
Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event
Description
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.
Time Frame
Up to 8 years
Secondary Outcome Measure Information:
Title
Metastasis-free survival (MFS)
Description
MFS is measured from time from randomization to first radiologic (as assessed by RECIST 1.1 criteria) or histologic evidence of metastatic disease or death due to any cause.
Time Frame
Up to 8 years
Title
Overall Survival (OS)
Description
OS is defined as time from randomization to death.
Time Frame
Up to 8 years
Title
Overall Response Rate (ORR)
Description
ORR is defined as proportion of participants who have complete response (CR) (defined as Negative biopsy, and Computed tomography/Magnetic resonance imaging [CT/MRI] of chest, abdomen, and pelvis showing no evidence of local recurrence, progression, or metastatic disease) or partial response (PR): (defined as down staging: biopsy proven non-muscle invasive disease less than [<] T1 and CT/MRI of chest, abdomen, and pelvis showing no evidence of metastatic disease) or non-response (those not achieving a complete response or down-staging, or those who do not undergo a biopsy will be considered non-responders).
Time Frame
Up to 8 years
Title
Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)
Description
Number of Participants with AEs by Severity as assessed by CTCAE version 5 will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.
Time Frame
Up to 8 years
Title
Number of Participants with AEs by Severity according to Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)
Description
NCI PRO-CTCAE is a patient-reported item library used to evaluate symptomatic treatment-emergent adverse events in participants on cancer clinical trials. The items selected for this study include all NCI PRO-CTCAE gastrointestinal items and urinary items. These items include taste changes, decreased appetite, nausea, vomiting, heartburn, gas, bloating, hiccups, constipation, diarrhea, abdominal pain, fecal incontinence, painful, urination, urinary urgency, urinary frequency, change in usual urine color, and urinary incontinence.
Time Frame
Up to 8 years
Title
Number of Participants with Clinical Laboratory Abnormalities
Description
Number of participants with clinical laboratory abnormalities will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Time Frame
Up to 8 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 within normal range or stable on hormone supplementation per investigator assessment. 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trials
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Saint John's Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Individual Site Status
Completed
Facility Name
Foothills Urology - Golden Off
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Individual Site Status
Recruiting
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
DuPage Medical Group
City
Lisle
State/Province
Illinois
ZIP/Postal Code
60532
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Seidman Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Adult Pediatric Urology & Urogynecology, P.C
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Name
New Jersey Urology LLC
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Individual Site Status
Completed
Facility Name
Cardiology Clinic at Montefiore Hutchinson Complex
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Vidant Urology - Greenville
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
MidLantic Urology
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Medical Branch
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
Fundacion Intecnus
City
Bariloche
ZIP/Postal Code
8400
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
City
Buenos Aires
ZIP/Postal Code
C1419AHN
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Medico Especializado Alexander Fleming
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Urologico Profesor Bengio
City
Córdoba
ZIP/Postal Code
X5000KPH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sanatorio Allende Cerro
City
Córdoba
ZIP/Postal Code
X5004FHP
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Oncologico Riojano Integral (Cori)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigacion Pergamino SA
City
Pergamino
ZIP/Postal Code
B2700CPM
Country
Argentina
Individual Site Status
Recruiting
Facility Name
CEDIC Centro de Investigaciones Clinicas
City
Viedma
ZIP/Postal Code
R8500EYO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Flinders Medical Centre
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Completed
Facility Name
Krankenhaus der barmherzigen Schwestern
City
Linz
ZIP/Postal Code
4010
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Salzburg - Landeskrankenhaus
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Hopital Erasme
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Sint-Lucas
City
Assebroek
ZIP/Postal Code
8310
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Sint-Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Az Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Completed
Facility Name
Algemeen Ziekenhuis Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Fundacao Pio XII
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundação Hospitalar São Francisco de Assis
City
Belo Horizonte
ZIP/Postal Code
31110-580
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Liga Paranaense de Combate ao Cancer
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro Regional Integrado de Oncologia - CRIO
City
Fortaleza
ZIP/Postal Code
60336-232
Country
Brazil
Individual Site Status
Completed
Facility Name
Clinica de Oncologia Reichow
City
Jardim Blumenau
ZIP/Postal Code
89010-340
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Doutor Amaral Carvalho
City
Jau
ZIP/Postal Code
17210-080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Liga Norte Riograndense Contra O Cancer
City
Natal
ZIP/Postal Code
59062-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital das Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Regional do Câncer - Hospital de Esperança
City
Presidente Prudente
ZIP/Postal Code
19013-050
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Rafael
City
Salvador
ZIP/Postal Code
41253-190
Country
Brazil
Individual Site Status
Recruiting
Facility Name
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
City
Santo André
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
City
Sao Paulo
ZIP/Postal Code
04039-004
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Sociedade Beneficente de Senhoras - Hospital Sirio Libanes
City
Sao Paulo
ZIP/Postal Code
04784180
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
City
São Paulo
ZIP/Postal Code
05652-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro Oncológico do Triângulo
City
Uberlândia
ZIP/Postal Code
38408-150
Country
Brazil
Individual Site Status
Recruiting
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU de Québec -L'Hôtel-Dieu de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Cancer hospital
City
Changsha Shi
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Xiangya Hospital of Central Sourth University
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital of Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Name
Guangzhou First Municipal People's Hospital
City
Guang Zhou Shi
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jiaxing
City
Jiaxing
ZIP/Postal Code
11026101-1
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
Qingdao Municipal Hospital
City
Qingdao
ZIP/Postal Code
266011
Country
China
Individual Site Status
Recruiting
Facility Name
Ruijin Hospital
City
Shanghai
ZIP/Postal Code
200003
Country
China
Individual Site Status
Recruiting
Facility Name
Renji Hospital
City
Shanghai
ZIP/Postal Code
200020
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
ZIP/Postal Code
300042
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou Shi
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Wuhan Union Hospital
City
Wuhan
ZIP/Postal Code
430023
Country
China
Individual Site Status
Recruiting
Facility Name
Wuhan Tongji Hospital, Tongji Medical College
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
ZIP/Postal Code
264000
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Slezska nemocnice v Opave
City
Opava
ZIP/Postal Code
746 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Plze
City
Plzen-Bory
ZIP/Postal Code
305 99
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Urocentrum Praha
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Thomayerova nemocnice
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Individual Site Status
Completed
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Nemocnice Na Bulovce
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Recruiting
Facility Name
ICH Hopital A. Morvan
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Name
Pole Sante Leonard de Vinci
City
Chambray-lès-Tours
ZIP/Postal Code
37170
Country
France
Individual Site Status
Recruiting
Facility Name
Clinique Sainte Marguerite
City
Hyeres
ZIP/Postal Code
83400
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Terminated
Facility Name
Polyclinique de Limoges - Francois Chenieux
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Edouard Herriot
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Européen
City
Marseille
ZIP/Postal Code
13698
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Regional du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Completed
Facility Name
CHU Nîmes
City
Nimes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Europeen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Name
Clinical La Croix Du Sud - Ramsay Santé
City
Quint-Fonsegrives
ZIP/Postal Code
31130
Country
France
Individual Site Status
Recruiting
Facility Name
Centre hospitalier universitaire de St Etienne
City
Saint-Etienne Cedex 2
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Prive
City
Saint-Grégoire
ZIP/Postal Code
35760
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Name
Urologicum Duisburg
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Düsseldorf
City
Düesseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Name
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
City
Frankfurt Am Main
ZIP/Postal Code
60431
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Herne - Urologie
City
Herne
ZIP/Postal Code
44625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Matthias Schulze - Germany
City
Markkleeberg
ZIP/Postal Code
04416
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Nürnberg Nord - Hautklinik
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Individual Site Status
Recruiting
Facility Name
Alexandra General Hospital of Athens
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
Metropolitan General A.E.
City
Holargos
ZIP/Postal Code
155 62
Country
Greece
Individual Site Status
Recruiting
Facility Name
Athens Medical Center
City
Maroussi
ZIP/Postal Code
151 25
Country
Greece
Individual Site Status
Recruiting
Facility Name
Metropolitan Hospital
City
Neo Faliro
ZIP/Postal Code
18547
Country
Greece
Individual Site Status
Recruiting
Facility Name
Bioclinic - Thessaloniki
City
Thessaloniki
ZIP/Postal Code
546 22
Country
Greece
Individual Site Status
Recruiting
Facility Name
Euromedica General Clinic
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Individual Site Status
Recruiting
Facility Name
'Papageorgiou' General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
TK 56403
Country
Greece
Individual Site Status
Recruiting
Facility Name
Anassa General Clinic
City
Volos
ZIP/Postal Code
38333
Country
Greece
Individual Site Status
Recruiting
Facility Name
Orszagos Onkologiai Intezet
City
Budapest N/a
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Eszak-Pesti Centrumkorhaz - Honvedkorhaz
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bajcsy-Zsilinszky Kórház és Rendelőintézet
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Completed
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Sujan Surgical Cancer Hospital & Amravati Cancer Foundation
City
Amravati
ZIP/Postal Code
400601
Country
India
Individual Site Status
Recruiting
Facility Name
Acharya Tulsi Regional Cancer Treatment Research Institute
City
Bikaner
ZIP/Postal Code
334 003
Country
India
Individual Site Status
Recruiting
Facility Name
Shatabdi Super Speciality Hospital
City
Nashik
ZIP/Postal Code
422005
Country
India
Individual Site Status
Recruiting
Facility Name
BLK Super Specialty Hospital
City
New Delhi
ZIP/Postal Code
110005
Country
India
Individual Site Status
Recruiting
Facility Name
Aakash Healthcare Super Speciality Hospital
City
New Delhi
ZIP/Postal Code
110075
Country
India
Individual Site Status
Recruiting
Facility Name
Rajiv Gandhi Cancer Institute & Research Centre
City
New Delhi
ZIP/Postal Code
110085
Country
India
Individual Site Status
Recruiting
Facility Name
Indira Gandhi Institute of Medical Sciences
City
Patna
ZIP/Postal Code
800014
Country
India
Individual Site Status
Recruiting
Facility Name
Jehangir Clinical Development Center Pvt Ltd
City
Pune
ZIP/Postal Code
411001
Country
India
Individual Site Status
Recruiting
Facility Name
Fondazione del Piemonte per I'Oncologia IRCC Candiolo
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Individual Site Status
Recruiting
Facility Name
SPDC Villa Scassi
City
Genova
ZIP/Postal Code
16100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Oncologico Veneto - IRCCS
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani
City
Pagani
ZIP/Postal Code
84016
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASL Napoli 2 Nord-SM delle Grazie Hospital
City
Pozzuoli
ZIP/Postal Code
80078
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Sant Andrea
City
Roma
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Name
Universita Campus Bio-Medico di Roma
City
Rome
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale Tumori Regina Elena
City
Rome
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Bortolo
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Completed
Facility Name
Aso Co.,Ltd Iizuka Hospital
City
Iizuka
ZIP/Postal Code
820-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
St.Marianna University Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nara Medical University Hospital
City
Kashihara
ZIP/Postal Code
634-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical University Hospital
City
Kawagoe-Shi
ZIP/Postal Code
350-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kimitsu Chuo Hospital
City
Kisarazu-shi
ZIP/Postal Code
292-8535
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
JOHAS Osaka Rosai Hospital
City
Osaka
ZIP/Postal Code
591-8025
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokuyama Central Hospital
City
Shunan
ZIP/Postal Code
745-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toranomon Hospital
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fujita Health University Hospital
City
Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamaguchi University Hospital
City
Ube
ZIP/Postal Code
755-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Medical Center
City
Yokohama
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
612-896
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Center
City
Namdong
ZIP/Postal Code
405 760
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan-si
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Oncologia Integral Satelite
City
Ciudad de México
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Consultorio Privado Dr Jose Arturo Rodriguez Rivera
City
Guadalajara
ZIP/Postal Code
45050
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro De Estudio Y Prevencion Del Cancer
City
Juchitan De Zaragoza
ZIP/Postal Code
70000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Dr. Marco Antonio Badillo Santoyo
City
Leon
ZIP/Postal Code
37000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
i Can Oncology Center
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Investigacion Clinica Chapultepec
City
Morelia
ZIP/Postal Code
58260
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Oncológico Potosino
City
San Luis Potosi
ZIP/Postal Code
78250
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V.
City
Zapopan
ZIP/Postal Code
45070
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Medyczne Pratia Poznan
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Individual Site Status
Completed
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Individual Site Status
Completed
Facility Name
Uniwersytecki Szpital Kliniczny
City
Wroclaw
ZIP/Postal Code
50556
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar e Universitario de Coimbra
City
Coimbra
ZIP/Postal Code
3000075
Country
Portugal
Individual Site Status
Recruiting
Facility Name
H. Santa Maria - Centro Hospitalar de Lisboa Norte
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Fundação Champalimaud
City
Lisbon
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital de Sao Joao
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Altlay Regional Oncology Dispensary
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Ivanovo Regional Oncology Dispensary
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Krasnoyarsk Regional Oncology Dispensary
City
Krasnoyarsk
ZIP/Postal Code
660133
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Hertzen Oncology Research Institute
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Completed
Facility Name
A. Tsyb Medical Radiological Research Center
City
Obninsk
ZIP/Postal Code
249031
Country
Russian Federation
Individual Site Status
Completed
Facility Name
BHI of Omsk region Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Ryazan State Medical University named after I.P.Pavlov
City
Ryazan
ZIP/Postal Code
390011
Country
Russian Federation
Individual Site Status
Completed
Facility Name
N.N. Petrov Research Institute Of Oncology
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Ogarev Mordovian State University
City
Saransk
ZIP/Postal Code
430005
Country
Russian Federation
Individual Site Status
Completed
Facility Name
State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Multifunctional clinical medical center 'Medical city'
City
Tyumen
ZIP/Postal Code
625041
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Bashkir State Medical University
City
Ufa
ZIP/Postal Code
450008
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Hosp. Univ. A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Virgen de Las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. de Jerez de La Frontera
City
Jerez de la Frontera
ZIP/Postal Code
11407
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. de La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Hm Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Corporacio Sanitari Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Memorial Hospital Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Adana Baskent Yuregir Hospital
City
Adana
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital
City
Ankara
ZIP/Postal Code
06050
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi
City
Balcova
ZIP/Postal Code
35330
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Bezmialem University Medical Faculty
City
Fatih
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medical Park Gaziantep Hastanesi
City
Gaziantep
ZIP/Postal Code
27584
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul Medeniyet University Goztepe Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34732
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Izmir Medical Park Hospital
City
Izmir
ZIP/Postal Code
35530
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Inonu University Medical Faculty
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Erciyes Univ MKD Hospital
City
Melikgazi
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Recruiting
Facility Name
T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma Hastanesi
City
Seyhan
ZIP/Postal Code
01330
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Chernihivskyi oblasnyi onkolohichnyi dyspanser
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Individual Site Status
Completed
Facility Name
SE Dnipropetrovsk Medical Academy
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Kharkiv Regional Clinical Hospital
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Individual Site Status
Completed
Facility Name
Khersonsky Regional Oncology Center
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Individual Site Status
Completed
Facility Name
Asklepion LLC
City
Kiev
ZIP/Postal Code
08173
Country
Ukraine
Individual Site Status
Completed
Facility Name
Kyiv City Clinical Hospital #3
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Individual Site Status
Completed
Facility Name
State Institution Academy Of Medical Sciences Of Ukraine
City
Kyiv
ZIP/Postal Code
04053
Country
Ukraine
Individual Site Status
Completed
Facility Name
P.L. Shupyk National Medical Academy of Post-Graduate Education
City
Kyiv
ZIP/Postal Code
04112
Country
Ukraine
Individual Site Status
Completed
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
ZIP/Postal Code
79000
Country
Ukraine
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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