A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations
THOR
A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations
4 other identifiers
interventional
629
26 countries
340
Brief Summary
The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-\[L\]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2018
Longer than P75 for phase_3
340 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2017
CompletedFirst Posted
Study publicly available on registry
January 4, 2018
CompletedStudy Start
First participant enrolled
March 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedResults Posted
Study results publicly available
May 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedApril 13, 2026
April 1, 2026
6.1 years
December 20, 2017
April 28, 2025
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall survival was measured from the date of randomization to the date of the participant's death.
From randomization (3 days prior to Cycle 1 Day 1) until death due to any cause (maximum up to 51.7 months)
Secondary Outcomes (20)
Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
From randomization (3 days prior to Cycle 1 Day 1) until disease progression or relapse from CR or death (maximum up to 51.7 months)
Objective Response Rate (ORR) Per RECIST Version 1.1
From start of the treatment (Day 1 Cycle 1) up to maximum of 51.7 months
Change From Baseline in Physical Functioning Scales of the Functional Assessment of Cancer Therapy - Bladder Cancer (FACT-Bl)
Baseline up to Cycle 11 (each cycle was of 21 days)
Time Until Symptom Deterioration
Randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months
Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS)
Baseline, 51.7 months
- +15 more secondary outcomes
Study Arms (4)
Cohort 1 (Arm 1A): Erdafitinib
EXPERIMENTALParticipants will be screened based on Fibroblast Growth Factor Receptor Inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-\[L\] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events \[AEs\]). Participants who enter in Long-term extension (LTE) phase will continue to receive the erdafitinib tablet as per investigator's decision.
Cohort 1 (Arm 1B): Vinflunine or Docetaxel
EXPERIMENTALParticipants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-\[L\] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m\^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m\^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities. Participants who enter in LTE phase will continue to receive Vinflunine or Docetaxel until the participant can commercially receive chemotherapy within the local healthcare system.
Cohort 2 (Arm 2A): Erdafitinib
EXPERIMENTALParticipants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-\[L\] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs). Participants who enter in LTE phase will continue to receive the erdafitinib tablet as per investigator's decision.
Cohort 2 (Arm 2B): Pembrolizumab
EXPERIMENTALParticipants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-\[L\] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities. Participants who enter in LTE phase will continue to receive the pembrolizumab until 2 years after the first dose of pembrolizumab (at start of study) or until the participant can commercially receive pembrolizumab within the local healthcare system, whichever comes first.
Interventions
FGFRi CTA will be used to determine molecular eligibility.
Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.
Participants will receive vinflunine 320 mg/m\^2 as a 20-minute intravenous infusion.
Participants will receive docetaxel 75 mg/m\^2 as a 1 hour intravenous infusion.
Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.
Eligibility Criteria
You may qualify if:
- Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than \[\<\] 50 percent \[%\] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
- Metastatic or surgically unresectable urothelial cancer
- Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization
- Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.
- A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin \[beta hCG\]) at Screening (urine or serum)
- Participants must meet appropriate molecular eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
- Adequate bone marrow, liver, and renal function
You may not qualify if:
- Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization
- Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.
- Symptomatic central nervous system metastases
- Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment
- Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
- Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.
- History of uncontrolled cardiovascular disease
- Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (345)
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, 99503, United States
University of Calif Davis Medical Center
Sacramento, California, 95817, United States
St. Helena Hospital - Martin-O'Neil Cancer Center
St. Helena, California, 94574, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
University of Miami Sylvester Cancer Center
Miami, Florida, 33136, United States
Mid Florida Hematology Oncology
Orange, Florida, 32763, United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318-0922, United States
Rush University
Chicago, Illinois, 60612, United States
Edward Hines Jr V A Hospital
Hines, Illinois, 60141, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Maryland Oncology Hematology, PA
Lanham, Maryland, 20706, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109-5000, United States
VA Sierra Nevada Health Care System
Reno, Nevada, 89509, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Weill Cornell Medical College
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Levine Cancer Institute, Carolinas HealthCare System
Charlotte, North Carolina, 28204, United States
W G Bill Hefner VA Medical Center
Salisbury, North Carolina, 28144, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Texas Oncology-Memorial City
Houston, Texas, 77024, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology Tyler
Tyler, Texas, 75702, United States
INOVA Dwiight &Martha Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
VA Puget Sound Healthcare System
Seattle, Washington, 98108, United States
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Buenos Aires, C1419AHN, Argentina
Centro Oncológico Korben
Buenos Aires, C1426AGE, Argentina
CEMIC Saavedra
Buenos Aires, C1431FWN, Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, C5000, Argentina
Centro Urologico Profesor Bengio
Córdoba, X5000KPH, Argentina
Hospital Privado de Comunidad
Mar del Plata, B7602CBM, Argentina
Centro de Investigacion Pergamino SA
Pergamino, B2700CPM, Argentina
Clínica Viedma
Viedma, R8500ACE, Argentina
Chris O'Brien Lifehouse
Camperdown, 2050, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, 3199, Australia
St George Hospital
Kogarah, 2217, Australia
Peter MacCallum Cancer Centre
Melbourne, 3000, Australia
Frankston Hospital
Melbourne, 3199, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
LKH-Univ. Klinikum Graz
Graz, 8036, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020, Austria
Krankenhaus der Barmherzigen Brüder
Vienna, 1020, Austria
Medical University Vienna MUV
Vienna, A-1090, Austria
OLV Ziekenhuis Aalst
Aalst, 9300, Belgium
ZNA Middelheim
Antwerp, 2020, Belgium
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Clinique Notre Dame de Grâce
Charleroi, 6000, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
UZ Gent
Ghent, 9000, Belgium
CHC MontLegia
Liège, 4000, Belgium
Sint-Augustinus AZ
Wilrijk, 2610, Belgium
CHU UCL Namur - Site Godinne
Yvoir, 5530, Belgium
Fundacao Pio XII
Barretos, 14784-400, Brazil
Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, 30130-100, Brazil
Nucleo de Ensino e Pesquisa do Instituto Mario Penna
Belo Horizonte, 30380-472, Brazil
Instituto de Oncologia do Parana
Curitiba, 80530-010, Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, 81520 060, Brazil
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
Goiânia, 74605-070, Brazil
Clínica de Neoplasias Litoral Ltda.
Itajaí, 88301-220, Brazil
Fundacao Doutor Amaral Carvalho
Jaú, 17210 080, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59075-740, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Hospital Nossa Senhora da Conceicao S A
Porto Alegre, 91350 200, Brazil
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, 20231 050, Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, 22250 905, Brazil
Hospital Sao Rafael
Salvador, 41253-190, Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, 09060-650, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, 15090-000, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, 01308 901, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01509 900, Brazil
Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia
São Paulo, 03102-002, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo, 04502-001, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652 900, Brazil
Instituto de Oncologia de Sorocaba Onco Clinicas Especializadas
Sorocaba, 18030-005, Brazil
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800, Bulgaria
Complex Oncology Center - Plovdiv EOOD
Plovdiv, 4004, Bulgaria
Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'
Sofia, 1407, Bulgaria
UMHAT Sofia Med
Sofia, 1797, Bulgaria
Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD
Varna, 9010, Bulgaria
BC Cancer Agency - Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Cancercare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4, Canada
Princess Margaret Hospital- UHN
Toronto, Ontario, M5G 2M9, Canada
Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021, China
Peking University First Hospital
Beijing, 100034, China
Beijing Friendship Hospital
Beijing, 100050, China
Peking University Third Hospital
Beijing, 100191, China
Beijing Hospital
Beijing, 100730, China
Peking Union Medical College Hospital
Beijing, 100730, China
The First Bethune Hospital of Jilin University
Changchun, 130021, China
Sichuan Provincial Peoples Hospital
Chengdu, 610000, China
Sichuan University Huaxi Hospital
Chengdu, 610041, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
Sun Yat Sen University Cancer Center
Guangzhou, 510060, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, 510120, China
Guangzhou First Municipal People's Hospital
Guangzhou, 510180, China
Zhejiang Provincial People's Hospital
Hangzhou, 310014, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310020, China
The First Affliated Hospital Of Nanchang University
Nanchang, 330006, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200127, China
Huadong Hospital Affiliated to Fudan University
Shanghai, 200400, China
Shengjing Hospital Of China Medical University
Shenyang, 110004, China
Shenzhen university General Hospital
Shenzhen, 518055, China
First Affiliated Hospital Of Wenzhou Medical College
Wenzhou, 325000, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061, China
Institut de Cancerologie de l Ouest ICO
Angers, 49055, France
Hopital Jean Minjoz
Besançon, 25030, France
Institut Bergonie
Bordeaux, 33000, France
CHRU Brest - Hopital Morvan
Brest, 29609, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Georges-François Leclerc
Dijon, 21079, France
Centre Oscar Lambret
Lille, 59000, France
Hôpital Privé Le Bois
Lille, 59000, France
Groupe Hospitalier Bretagne Sud
Lorient, 56322, France
Hopital de la Timone
Marseille, 13005, France
Institut Regional du Cancer de Montpellier Val d'Aurelle
Montpellier, 34298, France
Centre Antoine Lacassagne
Nice, 06189, France
Institut de Cancérologie du Gard
Nîmes, 30029, France
Hopital Europeen Georges-Pompidou
Paris, 75015, France
Hospital Saint-Louis
Paris, 75475, France
Hospices Civils de Lyon HCL
Pierre-Bénite, 69495, France
CHU De Poitiers
Poitiers, 86021, France
Centre Eugene Marquis
Rennes, 35062, France
Centre de radiothérapie et d'Oncologie médicale de l'Essonne
Ris-Orangis, 91130, France
Institut de Cancérologie de Loire
Saint-Priest-en-Jarez, 42271, France
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098, France
Institut Claudius Regaud
Toulouse, 31059, France
Centre Les Dentellieres
Valenciennes, 59300, France
Institut Gustave Roussy
Villejuif, 94805, France
Vivantes Klinikum Am Urban
Berlin, 10967, Germany
Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie
Braunschweig, 38126, Germany
Universitatsklinikum Carl Gustav Carcus Dresden
Dresden, 01307, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225, Germany
Friedrich-Alexander Universitaet Urologische Universitaetskl
Erlangen, 91054, Germany
Universitatsklinikum Frankfurt
Frankfurt, 60590, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Universitatsmedizin Gottingen
Göttingen, 37099, Germany
Universitätsmedizin Greifswald
Greifswald, 17475, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitatsklinikum Schleswig Holstein Campus Lubeck
Lübeck, 23538, Germany
Medizinische Fakultät Mannheim der Universität Heidelberg
Mannheim, 68167, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Studienpraxis Urologie Drs. Feyerabend
Nürtingen, 72622, Germany
Caritas-Krankenhaus St. Josef
Regensburg, 93053, Germany
Universitaetsmedizin Rostock
Rostock, 18057, Germany
MVZ-Onkologie Velbert GbR
Velbert, 42551, Germany
Kliniken Nordoberpfalz AG/Klinikum Weiden
Weiden, 92637, Germany
University of Athens Medical School - Regional General Hospi
Athens, 115 28, Greece
Errikos Dunant Hospital Center
Athens, 11526, Greece
Athens Medical Center
Athens, 15125, Greece
Metropolitan General A E
Athens, 15562, Greece
University Hospital Of Larissa
Larissa, 41110, Greece
University General Hospital of Rio Patras
Pátrai, 26504, Greece
Interbalkan European Medical Center
Thessaloniki, 14564, Greece
Euromedica General Clinic
Thessaloniki, 54645, Greece
Papageorgiou General Hospital Of Thessaloniki
Thessaloniki, 56403, Greece
Semmelweis Egyetem
Budapest, 1082, Hungary
Országos Onkológiai Intézet, Urogenitális Tumorok és Klinikai Farmakológiai Osztály
Budapest, 1122, Hungary
Budapesti Uzsoki Utcai Korhaz
Budapest, H-1145, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, 04400, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7624, Hungary
Rambam Health Care Campus
Haifa, 31096, Israel
Hadassah Medical Center
Jerusalem, 91120, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center, Beilinson Hospital
Petach Tikvah, 49100, Israel
Sourasky Medical Center
Tel Aviv, 64239, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Assaf Harofeh Medical Center
Tzrifin, 70300, Israel
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
Alessandria, 15121, Italy
Ospedale S. Donato - Asl 8 Arezzo
Arezzo, 52100, Italy
CRO IRCCS Istituto Nazionale Tumori
Aviano, 33081, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
Brescia, 25123, Italy
Istituti Ospitalieri di Cremona, AO di Cremona
Cremona, 26100, Italy
Oncologia Medica
Florence, 50139, Italy
SPDC Villa Scassi
Genova, Italy
UOC Oncologia Ospedale Provinciale di Macerata
Macerata, 62100, Italy
IRST Meldola Forli
Meldola, 47014, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
European Institute of Oncology
Milan, 20141, Italy
AOU Policlinico di Modena
Modena, 41124, Italy
IRCCS-Fondazione Pascale
Naples, 80131, Italy
Ospedale Maggiore della Carita
Novara, 28100, Italy
Aou San Luigi Gonzaga
Orbassano, 10043, Italy
Istituto Oncologico Veneto Iov Irccs Padova
Padova, 35128, Italy
AOU di Parma
Parma, 43126, Italy
IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncolo
Pavia, 27100, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST
Poggibonsi (SI), 53100, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
Siena, 53100, Italy
Oncologia Medica-Città Della Salute E Della Scienza Di Torino
Torino, 10123, Italy
Azienda Ospedaliero - Universitaria Ospedali Riuniti
Torrette Di Ancona, 60126, Italy
Chiba Cancer Center
Chiba, 260-8717, Japan
Hirosaki University Hospital
Hirosaki, 036-8563, Japan
National Cancer Center Hospital East
Kashiwa, 277 8577, Japan
Kagawa University Hospital
Kita Gun, 761 0793, Japan
Kobe City Medical Center General Hospital
Kobe, 650-0047, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, 343-8555, Japan
Aso Co.,Ltd Iizuka Hospital
Matsuyama, 791-0280, Japan
University of Miyazaki Hospital
Miyazaki, 889-1692, Japan
Nagano Municipal Hospital
Nagano, 381-8551, Japan
Aichi Cancer Center Hospital
Nagoya, 464 8681, Japan
Osaka International Cancer Institute
Osaka, 541 8567, Japan
Osaka City University Hospital
Osaka, 545 8586, Japan
Kindai University Hospital
Ōsaka-sayama, 589-8511, Japan
Gunma Prefectural Cancer Center
Ōta-ku, 373 8550, Japan
Kitasato University Hospital
Sagamihara, 252-0375, Japan
Toho University Sakura Medical Center
Sakura, 285-8741, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, 003-0804, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, 162-8666, Japan
Toranomon Hospital
Tokyo, 105-8470, Japan
The Cancer Institute Hospital of JFCR 1
Tokyo, 135 8550, Japan
University of Tsukuba Hospital
Tsukuba, 305 8576, Japan
Yamaguchi University Hospital
Ube, 755-8505, Japan
Yokohama City University Medical Center
Yokohama, 232 0024, Japan
Medicos Especialistas en Cancer, S.C.
Aguascalientes, 20230, Mexico
Centro Estatal de Cancerología de Chihuahua
Chihuahua City, 31000, Mexico
Oncologia Integral Satelite
Naucalpan, 53100, Mexico
Antoni van Leeuwenhoek
Amsterdam, 1066 CX, Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3430 EM, Netherlands
Haga ziekenhuis
The Hague, 2545 CH, Netherlands
Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
Bydgoszcz, 85 796, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, 02-507, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Uniwersytecki Szpital Kliniczny we Wroclawiu
Wroclaw, 50 556, Poland
Champalimaud Foundation Champalimaud Centre
Lisbon, 1400-038, Portugal
Hospital Lusíadas
Lisbon, 1500-458, Portugal
H. Santa Maria - Centro Hospitalar de Lisboa Norte
Lisbon, 1649-035, Portugal
Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
Lisbon, G1R 2J6, Portugal
Instituto Portugues de Oncologia
Porto, 4200072, Portugal
Altai Regional Oncology Dispensary
Barnaul, 656049, Russia
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
Chelyabinsk, 454087, Russia
Irkutsk Regional Oncology Dispensary
Irkutsk, 664035, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040, Russia
Kostroma regional oncology dispensary
Kostroma, 156005, Russia
Leningrad Regional Oncology Dispensary
Kuzmolovsky, 188663, Russia
City Clinical Hospital n.a. D.D.Pletnev
Moscow, 105077, Russia
FSBSI 'N. N. Blokhin Russian Cancer Research Center'
Moscow, 115478, Russia
Russian Scientific Center of Roentgenoradiology
Moscow, 117997, Russia
I.M. Sechenov First Moscow State Medical University
Moscow, 119991, Russia
Hertzen Oncology Research Institute
Moscow, 125284, Russia
City Clinical Hospital #1
Nal'chik, 360017, Russia
Privolzhsky District Medical Center under the Federal Medico-Biological Agency
Nizhny Novgorod, 603109, Russia
Clinical Oncology Dispensary
Omsk, 644013, Russia
GBUZ of Stavropol region Pyatigorsk Oncological Dispensary
Pyatigorsk, 357502, Russia
LLC 'Strategic Medical Systems'
Saint Petersburg, 192148, Russia
Clinical hopital n/a Petra velikogo
Saint Petersburg, 195067, Russia
Private Medical Institution Euromedservice
Saint Petersburg, 196603, Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, 197022, Russia
Russian Scientific Center of Radiology and Surgical Technologies
Saint Petersburg, 197758, Russia
Saint-Petersburg Clinical Scientific And Practical Center For Special Types Of Medical Care
Saint Petersburg, 197758, Russia
FGBOU Vo Mordovian National Research State University N. A. N.P. Ogareva
Saransk, 430032, Russia
Saratov State Medical University
Saratov, 410000, Russia
LLC Uromed
Smolensk, 214031, Russia
GBUZ Oncology Centre #2 of Healthcare Department of Krasno
Sochi, 354057, Russia
Multifunctional clinical medical center 'Medical city'
Tyumen, 625041, Russia
Bashkiria State Medical University
Ufa, 450000, Russia
Vologda Regional Oncological Dispensary
Vologda, 160012, Russia
Pusan National University Hospital
Busan, 49241, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
National Cancer Center
Goyang-si, 410-769, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Hosp. Univ. Infanta Cristina
Badajoz, 06006, Spain
Institut Català D'Oncologia-Hospital Universitari Germans Trias I Pujol
Badalona, 08916, Spain
Hosp Clinic de Barcelona
Barcelona, 08036, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08041, Spain
Hosp. San Pedro de Alcantara
Cáceres, 10003, Spain
Hosp Reina Sofia
Córdoba, 14004, Spain
Hosp. Univ. Virgen de Las Nieves
Granada, 18014, Spain
Complejo Hospitalario de Jaen
Jaén, 23007, Spain
Hosp. Univ. Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016, Spain
Hosp. Univ. Lucus Augusti
Lugo, 27003, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, 28220, Spain
ALTHAIA, Xarxa Assistencial Universitària de Manresa
Manresa, 08243, Spain
Hosp. de Navarra
Pamplona, 31008, Spain
Hosp. Virgen Macarena
Seville, 41009, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Hosp. Gral. Univ. Valencia
Valencia, 46014, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Hosp. Univ. Miguel Servet
Zaragoza, 50009, Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Chang Gung Medical Foundation
Niao-Sung Hsiang, 833, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Chi Mei Medical Center Yong Kang
Tainan, 710, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 11259, Taiwan
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan District, 333, Taiwan
Baskent University Adana Practice and Research Center Kisla Health Campus
Adana, 01120, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, 6100, Turkey (Türkiye)
Bezmialem University Medical Faculty
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
Bakirkoy Training and Research Hospital
Istanbul, 34147, Turkey (Türkiye)
Medipol Mega University Hospital
Istanbul, 34214, Turkey (Türkiye)
T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Pendik Training and Research Hospital
Istanbul, 34890, Turkey (Türkiye)
Ege University
Izmir, 35100, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, 35340, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, Turkey (Türkiye)
Inonu Universitesi Turgut Ozal Tip Merkezi, Ic Hastaliklari
Malatya, 44400, Turkey (Türkiye)
Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
Dnipro, 49100, Ukraine
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
Dnipro, 49102, Ukraine
MI Dnipropetrovsk Region Clinical Hospital n a I.I.Mechnikov
Dnipropetrovsk, 49005, Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, 76008, Ukraine
Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
Kharkiv, 61037, Ukraine
Municipal non-profit enterprise 'Regional Center of Oncology'
Kharkiv, 61070, Ukraine
National Cancer Institute
Kyiv, 03022, Ukraine
State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
Kyiv, 03115, Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
Lviv, 79010, Ukraine
Transkarpathian Regional University Oncology Clinic
Uzhhorod, 88000, Ukraine
Podilskiy Regional Center of Oncology
Vinnitsa, 21029, Ukraine
Zaokod
Zaporizhzhia, 69040, Ukraine
Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital
Zaporizhzhia, 69600, Ukraine
University Hospitals Bristol - Bristol Haematology & Oncolog
Bristol, BS2 8ED, United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Sarah Cannon Research Institute
London, W1G 6AD, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Manchester, M20 4BX, United Kingdom
Derriford Hospital-Department of Medical Oncology
Plymouth, PL6 8QH, United Kingdom
University of Sheffield
Sheffield, S10 2 RX, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5NG, United Kingdom
Related Publications (1)
Loriot Y, Matsubara N, Park SH, Huddart RA, Burgess EF, Houede N, Banek S, Guadalupi V, Ku JH, Valderrama BP, Tran B, Triantos S, Kean Y, Akapame S, Deprince K, Mukhopadhyay S, Stone NL, Siefker-Radtke AO; THOR Cohort 1 Investigators. Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2023 Nov 23;389(21):1961-1971. doi: 10.1056/NEJMoa2308849. Epub 2023 Oct 21.
PMID: 37870920DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- SR DIRECTOR ONCOLOGY CDTL
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 20, 2017
First Posted
January 4, 2018
Study Start
March 23, 2018
Primary Completion
April 15, 2024
Study Completion (Estimated)
December 31, 2026
Last Updated
April 13, 2026
Results First Posted
May 14, 2025
Record last verified: 2026-04