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NCT04658862Active, not recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
518 (actual)
First submitted
19 Nov 2020
Start date
7 Dec 2020
Primary completion date
30 Dec 2026
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT04658862
EU CT number
2023-507188-21-00
EudraCT number
2020-002620-36

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 518
  • From 7 Dec 2020 to the primary completion date, 30 Dec 2026
  • 221 sites in 25 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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
  • Evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has healed prior to randomization

Other

  • 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
  • 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

Who the study is looking for

  • Ineligible for or have elected not to undergo radical cystectomy
  • All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade less than (\<) 2 prior to randomization
  • Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
  • Thyroid function tests are within the normal range per investigator assessment (or stable on hormone supplementation). Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal test results
  • Adequate bone marrow, liver, and renal function: Bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding two weeks): Absolute neutrophil count (ANC) greater than or equal to (\>=) 1,500/cubic millimeters (mm\^3); Platelet count \>=80,000/mm\^3; Hemoglobin \>=9.0 grams per deciliter (g/dL); Liver function: (Total bilirubin less than or equal to (\<=) 1.5 \* upper limit of normal (ULN) or direct bilirubin \<= ULN for participants with total bilirubin levels greater than (\>)1.5\*ULN (except participants with Gilbert's Syndrome, who must have a total bilirubin \< 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (\<=) 2.5\* institutional ULN); Renal function: Creatinine clearance \>=30 mL/min using the Cockcroft-Gault formula. 24-hour creatinine clearance test will also be accepted for estimating renal function in situations where Cockcroft-Gault formula is not a good predictor of estimating adequate renal function

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (221)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fundación Intecnus
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BarilocheArgentinaUnknown status
Asociación de Beneficencia Hospital Sirio Libanés
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Buenos AiresArgentinaUnknown status
Hospital Italiano de Buenos Aires
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Buenos AiresArgentinaUnknown status
Instituto Medico Especializado Alexander Fleming
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Buenos AiresArgentinaUnknown status
Centro de Urologia (CDU)
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Ciudad Automoma Buenos AiresArgentinaUnknown status
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
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CórdobaArgentinaUnknown status
Sanatorio Allende Cerro
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CórdobaArgentinaUnknown status
Centro Urológico Profesor Bengió
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CórdobaArgentinaUnknown status
Centro Oncologico Riojano Integral (Cori)
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La RiojaArgentinaUnknown status
Centro de Investigación Pergamino SA
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PergaminoArgentinaUnknown status
CEDIC Centro de Investigaciones Clinicas
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ViedmaArgentinaUnknown status
Medical University of Vienna
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ViennaAustriaActive, not recruiting
Flinders Medical Centre
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Bedford ParkAustraliaUnknown status
Az St-Jan Brugge-Oostende A.V.
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BruggeBelgiumCompleted
Fundacao Pio XII
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BarretosBrazilUnknown status
Fundação Hospitalar São Francisco de Assis
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Belo HorizonteBrazilUnknown status
Liga Paranaense de Combate ao Cancer
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CuritibaBrazilUnknown status
Centro Regional Integrado de Oncologia - CRIO
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FortalezaBrazilUnknown status
Clinica de Oncologia Reichow
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Jardim BlumenauBrazilUnknown status
Fundacao Doutor Amaral Carvalho
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JaúBrazilUnknown status
Liga Norte Riograndense Contra o Cancer
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NatalBrazilUnknown status
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
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Porto AlegreBrazilUnknown status
Associacao Hospitalar Moinhos de Vento
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Porto AlegreBrazilUnknown status
Hospital das Clinicas de Porto Alegre
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Porto AlegreBrazilUnknown status
Hospital Regional do Cancer Hospital de Esperanca
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Presidente PrudenteBrazilUnknown status
Hospital Sao Rafael
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SalvadorBrazilUnknown status
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
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Santo AndréBrazilUnknown status
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base
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São José do Rio PretoBrazilUnknown status
Hospital Alemão Oswaldo Cruz
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São PauloBrazilUnknown status
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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São PauloBrazilUnknown status
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São PauloBrazilUnknown status
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
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São PauloBrazilUnknown status
Fundacao Antonio Prudente A C Camargo Cancer Center
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São PauloBrazilUnknown status
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
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São PauloBrazilUnknown status
Centro Oncológico do Triângulo
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UberlândiaBrazilUnknown status
McGill University Health Centre
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MontrealCanadaUnknown status
CHU de Quebec - L'Hôtel-Dieu de Québec
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QuébecCanadaUnknown status
Centre Hospitalier Universitaire de Sherbrooke
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SherbrookeCanadaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Beijing Hospital
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
The Third Xiangya Hospital of Central Sourth University
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ChangshaChinaUnknown status
Hunan Cancer hospital
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Changsha ShiChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
Chongqing University Cancer Hospital
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ChongqingChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
Guangzhou First Municipal People's Hospital
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GuangzhouChinaUnknown status
Zhejiang Provincial People's Hospital
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HangzhouChinaUnknown status
The First Hospital Of Jiaxing
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JiaxingChinaUnknown status
Nanjing Drum Tower hospital
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NanjingChinaUnknown status
QingDao Municipal Hospital
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QingdaoChinaUnknown status
Ruijin hospital
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ShanghaiChinaUnknown status
RenJi Hospital
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ShanghaiChinaUnknown status
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Wuhan Union Hospital
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WuhanChinaUnknown status
Wuhan Tongji Hospital Tongji Medical College
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WuhanChinaUnknown status
Yantai Yuhuangding Hospital
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YantaiChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Fakultni nemocnice v Motole
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PragueCzechiaCompleted
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaCompleted
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyActive, not recruiting
Klinikum Nuernberg
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NurembergGermanyActive, not recruiting
Hospital Germans Trias i Pujol
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BadalonaSpainCompleted
Fundació Puigvert
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BarcelonaSpainCompleted
Hospital Universitario Puerta del Mar
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CadizSpainCompleted
Hospital Universitario Virgen de las Nieves
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GranadaSpainCompleted
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainCompleted
Clinica Universidad de Navarra
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MadridSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario HM Sanchinarro
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MadridSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
Parc Tauli Hospital Universitari
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SabadellSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Fundación Instituto Valenciano de Oncología
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ValenciaSpainCompleted
Hopital Europeen Marseille
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MarseilleFranceCompleted
Centre Medico Chirurgical Ambroise Pare Hartmann
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Neuilly-Sur-SeineFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceCompleted
Alexandra Hospital
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AthensGreeceActive, not recruiting
Athens Medical Center S.A.
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ThessalonikiGreeceActive, not recruiting
St. Luke's Hospital S.A.
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ThessalonikiGreeceActive, not recruiting
Euromedica General Clinic of Thessaloniki
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ThessalonikiGreeceActive, not recruiting
Ioannou Private Clinic-Private Polyclinics S.A.
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VolosGreeceActive, not recruiting
Orszagos Onkologiai Intezet
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Budapest XIIHungaryCompleted
Sujan Surgical Cancer Hospital & Amravati Cancer Foundation
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AmravatiIndiaUnknown status
Bangalore Medical College and Research Institute
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BangaloreIndiaUnknown status
Acharya Tulsi Regional Cancer Treatment Research Institute
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BikanerIndiaUnknown status
Shatabdi Super Speciality Hospital
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NashikIndiaUnknown status
BLK Super Specialty Hospital
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New DelhiIndiaUnknown status
Rajiv Gandhi Cancer Institute & Research Centre
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New DelhiIndiaUnknown status
Aakash Healthcare Super Speciality Hospital
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New DelhiIndiaUnknown status
Indira Gandhi Institute of Medical Sciences
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PatnaIndiaUnknown status
Jehangir Clinical Development Center Pvt Ltd
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PuneIndiaUnknown status
Azienda Unita Sanitaria Locale Di Modena
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CarpiItalyCompleted
Azienda Sanitaria Locale Napoli 2 Nord
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FrattamaggioreItalyCompleted
IRCCS Ospedale Policlinico San Martino
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GenoaItalyCompleted
Istituto Europeo di Oncologia s.r.l
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MilanItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
Istituto Oncologico Veneto
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PadovaItalyCompleted
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyCompleted
Humanitas Mirasole S.p.A.
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RozzanoItalyCompleted
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyCompleted
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
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VareseItalyCompleted
Aso Co.,Ltd Iizuka Hospital
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IizukaJapanUnknown status
St Marianna University Hospital
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KanagawaJapanUnknown status
Nara Medical University Hospital
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KashiharaJapanUnknown status
Saitama Medical University Hospital
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Kawagoe-ShiJapanUnknown status
Kimitsu Chuo Hospital
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Kisarazu-shiJapanUnknown status
Nagasaki University Hospital
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NagasakiJapanUnknown status
JOHAS Osaka Rosai Hospital
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OsakaJapanUnknown status
Tokuyama Central Hospital
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ShūnanJapanUnknown status
Toranomon Hospital
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TokyoJapanUnknown status
Nippon Medical School Hospital
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TokyoJapanUnknown status
Fujita Health University Hospital
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ToyoakeJapanUnknown status
Yamaguchi University Hospital
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UbeJapanUnknown status
Yokohama City University Medical Center
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YokohamaJapanUnknown status
Inje University Haeundae Paik Hospital
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BusanSouth KoreaUnknown status
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaUnknown status
Keimyung University Dongsan Hospital
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DaeguSouth KoreaUnknown status
Samsung Medical Center
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Gangnam-GuSouth KoreaUnknown status
National Cancer Center
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Goyang-siSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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Hwasun-gunSouth KoreaUnknown status
Gachon University Gil Medical Center
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NamdongSouth KoreaUnknown status
Gangnam Severance Hospital
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SeoulSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaUnknown status
Severance hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Hanyang University Hospital
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SeoulSouth KoreaUnknown status
Pusan National University Yangsan Hospital
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YangsanSouth KoreaUnknown status
Consultorio Privado Dr Jose Arturo Rodriguez Rivera
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GuadalajaraMexicoUnknown status
Hospital Civil de Guadalajara Fray Antonio Alcalde
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GuadalajaraMexicoUnknown status
Centro De Estudio Y Prevencion Del Cancer
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Juchitán de ZaragozaMexicoUnknown status
Dr. Marco Antonio Badillo Santoyo
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LeónMexicoUnknown status
Oncologia Integral Satelite
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Mexico CityMexicoUnknown status
i Can Oncology Center
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MonterreyMexicoUnknown status
Centro de Investigacion Clinica Chapultepec
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MoreliaMexicoUnknown status
Centro de Investigacion Clinica de Oaxaca
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Oaxaca CityMexicoUnknown status
Oaxaca Site Management Organization S.C.
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Oaxaca CityMexicoUnknown status
Oncologico Potosino
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San Luis Potosí CityMexicoUnknown status
Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V.
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ZapopanMexicoUnknown status
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
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SiedlcePolandUnknown status
Centrum Medyczne Pratia Poznan
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SkórzewoPolandUnknown status
Centralny Szpital Kliniczny MSWiA w Warszawie
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WarsawPolandUnknown status
Uniwersytecki Szpital Kliniczny
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WroclawPolandUnknown status
Unidade Local De Saude De Almada-Seixal E.P.E.
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AlmadaPortugalCompleted
Unidade Local de Saúde de Coimbra, E.P.E.
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CoimbraPortugalCompleted
Unidade Local De Saude De Sao Jose E.P.E.
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LisbonPortugalCompleted
Hospital De Santa Maria E.P.E.
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LisbonPortugalCompleted
Champalimaud Clinical Centre
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LisbonPortugalCompleted
Altlay Regional Oncology Dispensary
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BarnaulRussiaUnknown status
Ivanovo regional oncology dispensary
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IvanovoRussiaUnknown status
Krasnoyarsk Regional Oncology Dispensary
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KrasnoyarskRussiaUnknown status
Hertzen Oncology Research Institute
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MoscowRussiaUnknown status
A. Tsyb Medical Radiological Research Center
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ObninskRussiaUnknown status
BHI of Omsk region "Clinical Oncology Dispensary"
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OmskRussiaUnknown status
Ryazan State Medical University named after I.P.Pavlov
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RyazanRussiaUnknown status
N.N. Petrov Research Institute Of Oncology
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Saint PetersburgRussiaUnknown status
Ogarev Mordovian State University
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SaranskRussiaUnknown status
State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio
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SochiRussiaUnknown status
Multifunctional clinical medical center 'Medical city'
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TyumenRussiaUnknown status
Bashkir State Medical University
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UfaRussiaUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Tri-Service General Hospital
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TaipeiTaiwanUnknown status
Chang Gung Memorial Hospital, Linkou Branch
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TaoyuanTaiwanUnknown status
Chernihivskyi oblasnyi onkolohichnyi dyspanser
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ChernihivUkraineUnknown status
SE Dnipropetrovsk Medical Academy
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DniproUkraineUnknown status
Kharkiv Regional Clinical Hospital
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KharkivUkraineUnknown status
Khersonsky Regional Oncology Center
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KhersonUkraineUnknown status
Asklepion LLC
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KievUkraineUnknown status
State Institution Academy Of Medical Sciences Of Ukraine
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KyivUkraineUnknown status
Kyiv City Clinical Hospital #3
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KyivUkraineUnknown status
P.L. Shupyk National Medical Academy of Post-Graduate Education
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KyivUkraineUnknown status
Lviv Regional Clinical Hospital
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LvivUkraineUnknown status
University Hospitals Seidman Cancer Center
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Ann ArborUnited StatesUnknown status
Winship Cancer Institute of Emory University
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AtlantaUnited StatesUnknown status
MidLantic Urology
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Bala-CynwydUnited StatesUnknown status
Boca Raton Regional Hospital
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Boca RatonUnited StatesUnknown status
Wexner Medical Center at the Ohio State University
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ColumbusUnited StatesUnknown status
The Urology Center of Colorado
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DenverUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Foothills Urology - Golden Off
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GoldenUnited StatesUnknown status
Vidant Urology - Greenville
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GreenvilleUnited StatesUnknown status
Urological Research Network
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HialeahUnited StatesUnknown status
Houston Metro Urology
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HoustonUnited StatesUnknown status
University of Tennessee Medical Center
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KnoxvilleUnited StatesUnknown status
University of Texas Medical Branch
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League CityUnited StatesUnknown status
DuPage Medical Group
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LisleUnited StatesUnknown status
Loma Linda Univ Faculty Medic
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Loma LindaUnited StatesUnknown status
University of Southern California
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Los AngelesUnited StatesUnknown status
Garden State Urology
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MorristownUnited StatesUnknown status
Carolina Urologic Research Center
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Myrtle BeachUnited StatesUnknown status
Virginia Oncology Associates
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NorfolkUnited StatesUnknown status
Stephenson Cancer Center
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Oklahoma CityUnited StatesUnknown status
Adult Pediatric Urology & Urogynecology, P.C
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OmahaUnited StatesUnknown status
Memorial Healthcare System
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Pembroke PinesUnited StatesUnknown status
Providence Saint John's Health Center
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Santa MonicaUnited StatesUnknown status
Stanford University Medical Center
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StanfordUnited StatesUnknown status
Cardiology Clinic at Montefiore Hutchinson Complex
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The BronxUnited StatesUnknown status
Michigan Institute of Urology
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TroyUnited StatesUnknown status
New Jersey Urology LLC
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Voorhees TownshipUnited StatesUnknown status
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
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Winston-SalemUnited StatesUnknown status
Adana Baskent Yuregir Hospital
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AdanaTurkey (Türkiye)Unknown status
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
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AnkaraTurkey (Türkiye)Unknown status
Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital
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AnkaraTurkey (Türkiye)Unknown status
Dokuz Eylul Universitesi Tip Fakultesi
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BalçovaTurkey (Türkiye)Unknown status
Bezmialem University Medical Faculty
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FatihTurkey (Türkiye)Unknown status
Medical Park Gaziantep Hastanesi
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Istanbul University Cerrahpasa Medical Faculty
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Istanbul Medeniyet University Goztepe Training and Research Hospital
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Izmir Medical Park Hospital
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Inonu University Medical Faculty
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MalatyaTurkey (Türkiye)Unknown status
Erciyes Univ MKD Hospital
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T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma Hastanesi
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SeyhanTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.