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NCT03473743Active, not recruitingPhase 1/2

A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer

Source: ClinicalTrials.gov · Last updated 28 Aug 2026

Brief summary (registry, in English)

The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
125 (actual)
First submitted
14 Mar 2018
Start date
5 Apr 2018
Primary completion date
30 Sept 2022
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT03473743
EU CT number
2023-510295-31-00
EudraCT number
2017-001980-19

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 125
  • From 5 Apr 2018 to the primary completion date, 30 Sept 2022
  • 127 sites in 13 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

  • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, participants who have received the following prior antitumor therapy: received nitrosoureas and mitomycin C within 6 weeks
  • Phase 1b erdafitinib + cetrelimab cohort: Chemotherapy within 3 weeks of Cycle 1 Day 1; Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort and Phase 2: Prior neoadjuvant/adjuvant chemotherapy is allowed if the last dose was given \>12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation
  • Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant/adjuvant checkpoint inhibitor therapy is allowed if the last dose was given more than (\>)12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation. PD-1 for non-muscle invasive bladder cancer is also allowed
  • Active malignancies requiring concurrent therapy other than urothelial cancer

Other

  • Symptomatic central nervous system metastases

Who the study is looking for

  • Histologic demonstration of transitional cell carcinoma of the urothelium. Variant urothelial carcinoma histologies such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
  • Metastatic or locally advanced urothelial cancer
  • Must have measurable disease by radiological imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline
  • Prior systemic therapy for metastatic urothelial cancer: (a) For Phase 1b erdafitinib + cetrelimab cohort: Any number of lines of prior therapy; (b) For Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: No prior systemic therapy for metastatic disease; and renal function for participants must have a creatinine clearance (CrCl) greater than (\>) 30 milliliter per minute (mL/min) to receive carboplatin and \>60 mL/min to receive cisplatin as calculated by Cockcroft Gault and (c) Phase 2: No prior systemic therapy for metastatic disease and cisplatin-ineligible based on: ECOG PS 0-1 and at least one of the following criteria: Renal function defined as creatinine clearance (CrCl) less than (˂) 60 mL/min as calculated by Cockcroft-Gault; Grade 2 or higher peripheral neuropathy per NCI-CTCAE version 5.0; Grade 2 or higher hearing loss per NCI-CTCAE version 5.0 OR ECOG PS 2
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: (a) Phase 1b erdafitinib + cetrelimab cohort: ECOG 0-2; (b) Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: ECOG 0-1 for cisplatin and 0-2 for carboplatin (c) Phase 2: ECOG 0-2

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

Full criteria on ClinicalTrials.gov

Sites (127)

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

SiteCityCountrySite status
Cliniques universitaires Saint-Luc
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BrusselsBelgiumUnknown status
ULB Hôpital Erasme
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BrusselsBelgiumUnknown status
Jolimont
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Haine-Saint-PaulBelgiumUnknown status
AZ Groeninge
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KortrijkBelgiumUnknown status
CHU de Liège - Domaine Universitaire du Sart Tilman
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LiègeBelgiumUnknown status
AZ Nikolaas - Campus Sint-Niklaas Moerland
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Sint-NiklaasBelgiumUnknown status
GZA Ziekenhuizen- Campus St Augustinus
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WilrijkBelgiumUnknown status
Fundacao Pio XII
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BarretosBrazilUnknown status
Santa Casa de Misericordia de Belo Horizonte
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Belo HorizonteBrazilUnknown status
Liga Paranaense de Combate ao Cancer
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CuritibaBrazilUnknown status
Oncocentro Servicos Medicos e Hospitalares Ltda - Oncocentro
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FortalezaBrazilUnknown status
Oncoclinicas Rio de Janeiro S A
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Rio de JaneiroBrazilUnknown status
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Rio de JaneiroBrazilUnknown status
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
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Santo AndréBrazilUnknown status
Brest Regional Oncology Dispensary
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BrestBelarusUnknown status
Grodno University Hospital
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GrodnoBelarusUnknown status
Gomel Regional Clinical Oncology Dispensary
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HomyelBelarusUnknown status
State Institution N.N. Alexandrov Republican Scientific and
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LesnoyBelarusUnknown status
Minsk city Clinical Oncological Dispensary
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MinskBelarusUnknown status
Mogilev Regional Hospital
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MogilevBelarusUnknown status
Vitebsk Regional Clinical Hospital
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VitebskBelarusUnknown status
Hosp Clinic de Barcelona
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BarcelonaSpainUnknown status
Hosp. Del Mar
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BarcelonaSpainUnknown status
Hosp. Univ. Ramon Y Cajal
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MadridSpainUnknown status
Hosp. Clinico San Carlos
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MadridSpainUnknown status
Hosp Univ Hm Sanchinarro
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MadridSpainUnknown status
Hosp Univ Fund Jimenez Diaz
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MadridSpainUnknown status
Hosp Virgen de La Victoria
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MálagaSpainUnknown status
Complexo Hosp. Univ. de Ourense
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OurenseSpainUnknown status
Complejo Hospitalario de Vigo
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PontevedraSpainUnknown status
Hosp. Quiron Madrid Pozuelo
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Pozuelo de AlarcónSpainUnknown status
Corporacio Sanitari Parc Tauli
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SabadellSpainUnknown status
Hosp. Univ. Marques de Valdecilla
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SantanderSpainUnknown status
H. Clinico Universitario de Santiago de Compostela
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Santiago de CompostelaSpainUnknown status
Hosp. Virgen Del Rocio
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SevilleSpainUnknown status
Hosp. Virgen Macarena
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SevilleSpainUnknown status
Hosp. Clinico Univ. de Valencia
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ValenciaSpainUnknown status
Instituto Valenciano de Oncologia
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ValenciaSpainUnknown status
Institut de Cancerologie de Ouest (ICO) Site Paul Papin
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AngersFranceUnknown status
Hôpital Saint-André
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BordeauxFranceUnknown status
Centre François Baclesse
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CaenFranceUnknown status
Centre Hospitalier Saint Louis
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La RochelleFranceUnknown status
Centre Leon Berard
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LyonFranceUnknown status
APHM - Hôpital Timone
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MarseilleFranceUnknown status
Hôpital Européen Georges Pompidou
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ParisFranceUnknown status
Clinique Sainte Anne
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StrasbourgFranceUnknown status
CHRU de Tours
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ToursFranceUnknown status
Institut de Cancérologie de Lorraine
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Vandœuvre-lès-NancyFranceUnknown status
Institut Gustave Roussy
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VillejuifFranceUnknown status
Royal Lancaster Infirmary
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LancasterUnited KingdomUnknown status
St. Bartholomew's Hospital
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LondonUnited KingdomUnknown status
University College London Hospitals NHS Foundation Trust
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LondonUnited KingdomUnknown status
Nottingham University Hospitals NHS Trust
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NottinghamUnited KingdomUnknown status
Cliniche Humanitas Gavazzeni
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BergamoItalyUnknown status
Istituto di Candiolo, IRCCS
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CandioloItalyUnknown status
Ospedale Di Zona B Ramazzini
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CarpiItalyUnknown status
UOS Oncologia Medica, A.O. Cannizzaro
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CataniaItalyUnknown status
Arcispedale S. Anna Ferrara
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FerraraItalyUnknown status
PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco
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LeccoItalyUnknown status
Ospedale Civile di Livorno
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LivornoItalyUnknown status
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyUnknown status
IRCCS Ospedale San Raffaele
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MilanItalyUnknown status
Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica
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PerugiaItalyUnknown status
AUSL di Piacenza-Ospedale Guglielmo Da Saliceto
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PiacenzaItalyUnknown status
Campus Bio Medico di Roma
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RomaItalyUnknown status
Azienda Socio Sanitaria Territoriale (ASST) della Valtellin
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SondrioItalyUnknown status
Azienda Ospedaliera S.Maria - Terni
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TerniItalyUnknown status
Azienda Ospedaliero Universitaria S.Maria Della Misericordia
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UdineItalyUnknown status
Chungnam National University Hospital
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DaejeonSouth KoreaUnknown status
Chonnam National University Hospital
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GwangjuSouth KoreaUnknown status
The Catholic University of Korea St. Vincent's Hospital
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Gyeonggi-doSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seoul Metropolitan Government Seoul National University Boramae Medical Center
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Pusan National University Yangsan Hospital
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YangsanSouth KoreaUnknown status
Przychodnia Lekarska Komed Roman Karaszewski
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KoninPolandUnknown status
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandUnknown status
LUX MED Onkologia Sp. z.o.o.
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WarsawPolandUnknown status
Centralny Szpital Kliniczny MSWiA w Warszawie
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WarsawPolandUnknown status
Altai Regional Oncology Dispensary
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BarnaulRussiaUnknown status
Ivanovo regional oncology dispensary
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IvanovoRussiaUnknown status
GUZ Kursk Regional Oncology Dispensary
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Kislino VillageRussiaUnknown status
Leningrad Regional Oncology Dispensary
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KuzmolovskyRussiaUnknown status
City Clinical Hospital n.a. D.D.Pletnev
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MoscowRussiaUnknown status
Russian Scientific Center of Roentgenoradiology
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MoscowRussiaUnknown status
Moscow City Clinical Hospital # 62
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MoscowRussiaUnknown status
Clinical Diagnostic Centre of Nizhny Novgorod Region
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Nizhny NovgorodRussiaUnknown status
Privolzhsky District Medical Centre
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Nizhny NovgorodRussiaUnknown status
Clinical Oncology Dispensary
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OmskRussiaUnknown status
LLC Novaya Clinica
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PyatigorskRussiaUnknown status
Russian Scientific Center of Radiology and Surgical Technologies
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Saint PetersburgRussiaUnknown status
Private Medical Institution Euromedservice
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Saint PetersburgRussiaUnknown status
Tambov Regional Oncology Clinical Dispansary
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TambovRussiaUnknown status
Multifunctional clinical medical center 'Medical city'
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TyumenRussiaUnknown status
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown 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
Chang Gung Memorial Hospital, Linkou Branch
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TaoyuanTaiwanUnknown status
Rocky Mountain Cancer Centers
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AuroraUnited StatesUnknown status
Levine Cancer Institute, Carolinas HealthCare System
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CharlotteUnited StatesUnknown status
Texas Oncology, P.A.
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Fort WorthUnited StatesUnknown status
Hackensack University Medical Center
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HackensackUnited StatesUnknown status
Penn State Hershey Cancer Institute
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HersheyUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Norton Cancer Institute
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LouisvilleUnited StatesUnknown status
Weill Cornell Medical College-NY Presbyterian Hospital
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New YorkUnited StatesUnknown status
Virginia Oncology Associates
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NorfolkUnited StatesUnknown status
Maryland Oncology Hematology, PA
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RockvilleUnited StatesUnknown status
Toledo Clinic Cancer Centers
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ToledoUnited StatesUnknown status
White Plains Hospital - Center for Cancer Care
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White PlainsUnited StatesUnknown status
Adana Acibadem Hospital
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AdanaTurkey (Türkiye)Unknown status
Memorial Ankara Hastanesi
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AnkaraTurkey (Türkiye)Unknown status
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
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AnkaraTurkey (Türkiye)Unknown status
Hacettepe University Medical Faculty
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AnkaraTurkey (Türkiye)Unknown status
Adnan Menderes University Training and Research Hospital
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AydinTurkey (Türkiye)Unknown status
Trakya University Medical Faculty
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EdirneTurkey (Türkiye)Unknown status
Istanbul University Cerrahpasa Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Istanbul Medeniyet University Goztepe Training and Research Hospital
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IstanbulTurkey (Türkiye)Unknown status
Ege University
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IzmirTurkey (Türkiye)Unknown status
Kocaeli University Medical Faculty
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KocaeliTurkey (Türkiye)Unknown status
Necmettin Erbakan University Meram Medical Faculty
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KonyaTurkey (Türkiye)Unknown status
Karadeniz Teknik University Medical Faculty
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TrabzonTurkey (Türkiye)Unknown status

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