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

NCT ID: NCT03390504

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 629 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-23
• Study Completion Date: 2026-12-31

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).

Detailed Description

A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up study completion for the respective cohort, whichever comes first). The study will have long term extension (LTE) period after clinical cutoff date is achieved for final analysis of each cohort and participants eligible in the opinion of the investigator, will continue to benefit from the study intervention. Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.

Conditions

Urothelial Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 (Arm 1A): Erdafitinib

Participants 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.

Group Type: EXPERIMENTAL

Erdafitinib

Intervention Type: DRUG

Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.

Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)

Intervention Type: DEVICE

FGFRi CTA will be used to determine molecular eligibility.

Cohort 1 (Arm 1B): Vinflunine or Docetaxel

Participants 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.

Group Type: EXPERIMENTAL

Vinflunine

Intervention Type: DRUG

Participants will receive vinflunine 320 mg/m\^2 as a 20-minute intravenous infusion.

Docetaxel

Intervention Type: DRUG

Participants will receive docetaxel 75 mg/m\^2 as a 1 hour intravenous infusion.

Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)

Intervention Type: DEVICE

FGFRi CTA will be used to determine molecular eligibility.

Cohort 2 (Arm 2A): Erdafitinib

Participants 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.

Group Type: EXPERIMENTAL

Erdafitinib

Intervention Type: DRUG

Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.

Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)

Intervention Type: DEVICE

FGFRi CTA will be used to determine molecular eligibility.

Cohort 2 (Arm 2B): Pembrolizumab

Participants 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.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: DRUG

Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.

Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)

Intervention Type: DEVICE

FGFRi CTA will be used to determine molecular eligibility.

Interventions

Erdafitinib

Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.

Intervention Type: DRUG

Vinflunine

Participants will receive vinflunine 320 mg/m\^2 as a 20-minute intravenous infusion.

Intervention Type: DRUG

Docetaxel

Participants will receive docetaxel 75 mg/m\^2 as a 1 hour intravenous infusion.

Intervention Type: DRUG

Pembrolizumab

Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.

Intervention Type: DRUG

Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)

FGFRi CTA will be used to determine molecular eligibility.

Intervention Type: DEVICE

Other Intervention Names

JNJ-42756493

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Alaska Urological Institute dba Alaska Clinical Research Center

Anchorage, Alaska, United States

University of Calif Davis Medical Center

Sacramento, California, United States

St. Helena Hospital - Martin-O'Neil Cancer Center

St. Helena, California, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

University of Miami Sylvester Cancer Center

Miami, Florida, United States

Mid Florida Hematology Oncology

Orange, Florida, United States

Piedmont Cancer Institute

Atlanta, Georgia, United States

Rush University

Chicago, Illinois, United States

Edward Hines Jr V A Hospital

Hines, Illinois, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Maryland Oncology Hematology, PA

Lanham, Maryland, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

VA Sierra Nevada Health Care System

Reno, Nevada, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Weill Cornell Medical College

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Levine Cancer Institute, Carolinas HealthCare System

Charlotte, North Carolina, United States

W G Bill Hefner VA Medical Center

Salisbury, North Carolina, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

Texas Oncology-Memorial City

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Texas Oncology Tyler

Tyler, Texas, United States

INOVA Dwiight &Martha Schar Cancer Institute

Fairfax, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

VA Puget Sound Healthcare System

Seattle, Washington, United States

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

Buenos Aires, , Argentina

Centro Oncológico Korben

Buenos Aires, , Argentina

CEMIC Saavedra

Buenos Aires, , Argentina

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, , Argentina

Centro Urologico Profesor Bengio

Córdoba, , Argentina

Hospital Privado de Comunidad

Mar del Plata, , Argentina

Centro de Investigacion Pergamino SA

Pergamino, , Argentina

Clínica Viedma

Viedma, , Argentina

Chris O'Brien Lifehouse

Camperdown, , Australia

Peninsula & South Eastern Haematology and Oncology Group

Frankston, , Australia

St George Hospital

Kogarah, , Australia

Peter MacCallum Cancer Centre

Melbourne, , Australia

Frankston Hospital

Melbourne, , Australia

Fiona Stanley Hospital

Murdoch, , Australia

LKH-Univ. Klinikum Graz

Graz, , Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, , Austria

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, , Austria

Krankenhaus der Barmherzigen Brüder

Vienna, , Austria

Medical University Vienna MUV

Vienna, , Austria

OLV Ziekenhuis Aalst

Aalst, , Belgium

ZNA Middelheim

Antwerp, , Belgium

Cliniques Universitaires Saint Luc

Brussels, , Belgium

Clinique Notre Dame de Grâce

Charleroi, , Belgium

AZ Maria Middelares

Ghent, , Belgium

UZ Gent

Ghent, , Belgium

CHC MontLegia

Liège, , Belgium

Sint-Augustinus AZ

Wilrijk, , Belgium

CHU UCL Namur - Site Godinne

Yvoir, , Belgium

Fundacao Pio XII

Barretos, , Brazil

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, , Brazil

Nucleo de Ensino e Pesquisa do Instituto Mario Penna

Belo Horizonte, , Brazil

Instituto de Oncologia do Parana

Curitiba, , Brazil

Liga Paranaense de Combate ao Cancer

Curitiba, , Brazil

Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

Goiânia, , Brazil

Clínica de Neoplasias Litoral Ltda.

Itajaí, , Brazil

Fundacao Doutor Amaral Carvalho

Jaú, , Brazil

Liga Norte Riograndense Contra O Cancer

Natal, , Brazil

Hospital das Clinicas de Porto Alegre

Porto Alegre, , Brazil

Hospital Nossa Senhora da Conceicao S A

Porto Alegre, , Brazil

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, , Brazil

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, , Brazil

Hospital Sao Rafael

Salvador, , Brazil

CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

Santo André, , Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

São José do Rio Preto, , Brazil

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, , Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, , Brazil

Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia

São Paulo, , Brazil

Instituto D Or de Pesquisa e Ensino IDOR

São Paulo, , Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, , Brazil

Instituto de Oncologia de Sorocaba Onco Clinicas Especializadas

Sorocaba, , Brazil

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, , Bulgaria

Complex Oncology Center - Plovdiv EOOD

Plovdiv, , Bulgaria

Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

Sofia, , Bulgaria

UMHAT Sofia Med

Sofia, , Bulgaria

Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD

Varna, , Bulgaria

BC Cancer Agency - Southern Interior

Kelowna, British Columbia, Canada

Vancouver Cancer Centre

Vancouver, British Columbia, Canada

Cancercare Manitoba

Winnipeg, Manitoba, Canada

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Princess Margaret Hospital- UHN

Toronto, Ontario, Canada

Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Peking University First Hospital

Beijing, , China

Beijing Friendship Hospital

Beijing, , China

Peking University Third Hospital

Beijing, , China

Beijing Hospital

Beijing, , China

Peking Union Medical College Hospital

Beijing, , China

The First Bethune Hospital of Jilin University

Changchun, , China

Sichuan Provincial Peoples Hospital

Chengdu, , China

Sichuan University Huaxi Hospital

Chengdu, , China

Chongqing University Cancer Hospital

Chongqing, , China

Sun Yat Sen University Cancer Center

Guangzhou, , China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, , China

Guangzhou First Municipal People's Hospital

Guangzhou, , China

Zhejiang Provincial People's Hospital

Hangzhou, , China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, , China

The First Affliated Hospital Of Nanchang University

Nanchang, , China

Nanjing Drum Tower Hospital

Nanjing, , China

Jiangsu Cancer Hospital

Nanjing, , China

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Huadong Hospital Affiliated to Fudan University

Shanghai, , China

Shengjing Hospital Of China Medical University

Shenyang, , China

Shenzhen university General Hospital

Shenzhen, , China

First Affiliated Hospital Of Wenzhou Medical College

Wenzhou, , China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, , China

Institut de Cancerologie de l Ouest ICO

Angers, , France

Hopital Jean Minjoz

Besançon, , France

Institut Bergonie

Bordeaux, , France

CHRU Brest - Hopital Morvan

Brest, , France

Centre Jean Perrin

Clermont-Ferrand, , France

Centre Georges-François Leclerc

Dijon, , France

Hôpital Privé Le Bois

Lille, , France

Centre Oscar Lambret

Lille, , France

Groupe Hospitalier Bretagne Sud

Lorient, , France

Hopital de la Timone

Marseille, , France

Institut Regional du Cancer de Montpellier Val d'Aurelle

Montpellier, , France

Centre Antoine Lacassagne

Nice, , France

Institut de Cancérologie du Gard

Nîmes, , France

Hopital Europeen Georges-Pompidou

Paris, , France

Hospital Saint-Louis

Paris, , France

Hospices Civils de Lyon HCL

Pierre-Bénite, , France

CHU De Poitiers

Poitiers, , France

Centre Eugene Marquis

Rennes, , France

Centre de radiothérapie et d'Oncologie médicale de l'Essonne

Ris-Orangis, , France

Institut de Cancérologie de Loire

Saint-Priest-en-Jarez, , France

Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

Strasbourg, , France

Institut Claudius Regaud

Toulouse, , France

Centre Les Dentellieres

Valenciennes, , France

Institut Gustave Roussy

Villejuif, , France

Vivantes Klinikum Am Urban

Berlin, , Germany

Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie

Braunschweig, , Germany

Universitatsklinikum Carl Gustav Carcus Dresden

Dresden, , Germany

Universitaetsklinikum Duesseldorf

Düsseldorf, , Germany

Friedrich-Alexander Universitaet Urologische Universitaetskl

Erlangen, , Germany

Universitatsklinikum Frankfurt

Frankfurt, , Germany

Universitatsklinikum Freiburg

Freiburg im Breisgau, , Germany

Universitatsmedizin Gottingen

Göttingen, , Germany

Universitätsmedizin Greifswald

Greifswald, , Germany

Asklepios Klinik Altona

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universitatsklinikum Schleswig Holstein Campus Lubeck

Lübeck, , Germany

Medizinische Fakultät Mannheim der Universität Heidelberg

Mannheim, , Germany

Universitaetsklinikum Muenster

Münster, , Germany

Studienpraxis Urologie Drs. Feyerabend

Nürtingen, , Germany

Caritas-Krankenhaus St. Josef

Regensburg, , Germany

Universitaetsmedizin Rostock

Rostock, , Germany

MVZ-Onkologie Velbert GbR

Velbert, , Germany

Kliniken Nordoberpfalz AG/Klinikum Weiden

Weiden, , Germany

University of Athens Medical School - Regional General Hospi

Athens, , Greece

Errikos Dunant Hospital Center

Athens, , Greece

Athens Medical Center

Athens, , Greece

Metropolitan General A E

Athens, , Greece

University Hospital Of Larissa

Larissa, , Greece

University General Hospital of Rio Patras

Pátrai, , Greece

Interbalkan European Medical Center

Thessaloniki, , Greece

Euromedica General Clinic

Thessaloniki, , Greece

Papageorgiou General Hospital Of Thessaloniki

Thessaloniki, , Greece

Semmelweis Egyetem

Budapest, , Hungary

Országos Onkológiai Intézet, Urogenitális Tumorok és Klinikai Farmakológiai Osztály

Budapest, , Hungary

Budapesti Uzsoki Utcai Korhaz

Budapest, , Hungary

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, , Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, , Hungary

Rambam Health Care Campus

Haifa, , Israel

Hadassah Medical Center

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Rabin Medical Center, Beilinson Hospital

Petach Tikvah, , Israel

Sourasky Medical Center

Tel Aviv, , Israel

The Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Assaf Harofeh Medical Center

Tzrifin, , Israel

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria

Alessandria, , Italy

Ospedale S. Donato - Asl 8 Arezzo

Arezzo, , Italy

CRO IRCCS Istituto Nazionale Tumori

Aviano, , Italy

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, , Italy

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

Brescia, , Italy

Istituti Ospitalieri di Cremona, AO di Cremona

Cremona, , Italy

Oncologia Medica

Florence, , Italy

SPDC Villa Scassi

Genova, , Italy

UOC Oncologia Ospedale Provinciale di Macerata

Macerata, , Italy

IRST Meldola Forli

Meldola, , Italy

IRCCS Ospedale San Raffaele

Milan, , Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

European Institute of Oncology

Milan, , Italy

AOU Policlinico di Modena

Modena, , Italy

IRCCS-Fondazione Pascale

Napoli, , Italy

Ospedale Maggiore della Carita

Novara, , Italy

Aou San Luigi Gonzaga

Orbassano, , Italy

Istituto Oncologico Veneto Iov Irccs Padova

Padua, , Italy

AOU di Parma

Parma, , Italy

IRCCS Policlinico San Matteo

Pavia, , Italy

Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncolo

Pavia, , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST

Poggibonsi (SI), , Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, , Italy

Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte

Siena, , Italy

Oncologia Medica-Città Della Salute E Della Scienza Di Torino

Torino, , Italy

Azienda Ospedaliero - Universitaria Ospedali Riuniti

Torrette Di Ancona, , Italy

Chiba Cancer Center

Chiba, , Japan

Hirosaki University Hospital

Hirosaki, , Japan

National Cancer Center Hospital East

Kashiwa, , Japan

Kagawa University Hospital

Kita Gun, , Japan

Kobe City Medical Center General Hospital

Kobe, , Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, , Japan

Aso Co.,Ltd Iizuka Hospital

Matsuyama, , Japan

University of Miyazaki Hospital

Miyazaki, , Japan

Nagano Municipal Hospital

Nagano, , Japan

Aichi Cancer Center Hospital

Nagoya, , Japan

Osaka International Cancer Institute

Osaka, , Japan

Osaka City University Hospital

Osaka, , Japan

Kindai University Hospital

Ōsaka-sayama, , Japan

Gunma Prefectural Cancer Center

Ōta-ku, , Japan

Kitasato University Hospital

Sagamihara, , Japan

Toho University Sakura Medical Center

Sakura, , Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, , Japan

Tokyo Women's Medical University Hospital

Shinjuku-ku, , Japan

Toranomon Hospital

Tokyo, , Japan

The Cancer Institute Hospital of JFCR

Tokyo, , Japan

University of Tsukuba Hospital

Tsukuba, , Japan

Yamaguchi University Hospital

Ube, , Japan

Yokohama City University Medical Center

Yokohama, , Japan

Medicos Especialistas en Cancer, S.C.

Aguascalientes, , Mexico

Centro Estatal de Cancerología de Chihuahua

Chihuahua City, , Mexico

Oncologia Integral Satelite

Naucalpan, , Mexico

Antoni van Leeuwenhoek

Amsterdam, , Netherlands

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, , Netherlands

Haga ziekenhuis

The Hague, , Netherlands

Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy

Bydgoszcz, , Poland

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, , Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, , Poland

Uniwersytecki Szpital Kliniczny we Wroclawiu

Wroclaw, , Poland

Champalimaud Foundation Champalimaud Centre

Lisbon, , Portugal

Hospital Lusíadas

Lisbon, , Portugal

H. Santa Maria - Centro Hospitalar de Lisboa Norte

Lisbon, , Portugal

Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos

Lisbon, , Portugal

Instituto Portugues de Oncologia

Porto, , Portugal

Altai Regional Oncology Dispensary

Barnaul, , Russia

Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

Chelyabinsk, , Russia

Irkutsk Regional Oncology Dispensary

Irkutsk, , Russia

Ivanovo Regional Oncology Dispensary

Ivanovo, , Russia

Kostroma regional oncology dispensary

Kostroma, , Russia

Leningrad Regional Oncology Dispensary

Kuzmolovsky, , Russia

City Clinical Hospital n.a. D.D.Pletnev

Moscow, , Russia

FSBSI 'N. N. Blokhin Russian Cancer Research Center'

Moscow, , Russia

Russian Scientific Center of Roentgenoradiology

Moscow, , Russia

I.M. Sechenov First Moscow State Medical University

Moscow, , Russia

Hertzen Oncology Research Institute

Moscow, , Russia

City Clinical Hospital #1

Nal'chik, , Russia

Privolzhsky District Medical Center under the Federal Medico-Biological Agency

Nizhny Novgorod, , Russia

Clinical Oncology Dispensary

Omsk, , Russia

GBUZ of Stavropol region Pyatigorsk Oncological Dispensary

Pyatigorsk, , Russia

LLC 'Strategic Medical Systems'

Saint Petersburg, , Russia

Clinical hopital n/a Petra velikogo

Saint Petersburg, , Russia

Private Medical Institution Euromedservice

Saint Petersburg, , Russia

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, , Russia

Russian Scientific Center of Radiology and Surgical Technologies

Saint Petersburg, , Russia

Saint-Petersburg Clinical Scientific And Practical Center For Special Types Of Medical Care

Saint Petersburg, , Russia

FGBOU Vo Mordovian National Research State University N. A. N.P. Ogareva

Saransk, , Russia

Saratov State Medical University

Saratov, , Russia

LLC Uromed

Smolensk, , Russia

GBUZ Oncology Centre #2 of Healthcare Department of Krasno

Sochi, , Russia

Multifunctional clinical medical center 'Medical city'

Tyumen, , Russia

Bashkiria State Medical University

Ufa, , Russia

Vologda Regional Oncological Dispensary

Vologda, , Russia

Pusan National University Hospital

Busan, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

National Cancer Center

Goyang-si, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Yonsei University Wonju Severance Christian Hospital

Wŏnju, , South Korea

Hosp. Univ. Infanta Cristina

Badajoz, , Spain

Institut Català D'Oncologia-Hospital Universitari Germans Trias I Pujol

Badalona, , Spain

Hosp Clinic de Barcelona

Barcelona, , Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, , Spain

Hosp. San Pedro de Alcantara

Cáceres, , Spain

Hosp Reina Sofia

Córdoba, , Spain

Hosp. Univ. Virgen de Las Nieves

Granada, , Spain

Complejo Hospitalario de Jaen

Jaén, , Spain

Hosp. Univ. Insular de Gran Canaria

Las Palmas de Gran Canaria, , Spain

Hosp. Univ. Lucus Augusti

Lugo, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Univ. La Paz

Madrid, , Spain

Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, , Spain

ALTHAIA, Xarxa Assistencial Universitària de Manresa

Manresa, , Spain

Hosp. de Navarra

Pamplona, , Spain

Hosp. Virgen Macarena

Seville, , Spain

Hosp. Virgen Del Rocio

Seville, , Spain

Hosp. Gral. Univ. Valencia

Valencia, , Spain

Hosp. Univ. I Politecni La Fe

Valencia, , Spain

Hosp. Univ. Miguel Servet

Zaragoza, , Spain

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, , Taiwan

Chang Gung Medical Foundation

Niao-Sung Hsiang, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Chi Mei Medical Center Yong Kang

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, , Taiwan

Chang-Gung Memorial Hospital, LinKou Branch

Taoyuan District, , Taiwan

Baskent University Adana Practice and Research Center Kisla Health Campus

Adana, , Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Bezmialem University Medical Faculty

Istanbul, , Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Bakirkoy Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Medipol Mega University Hospital

Istanbul, , Turkey (Türkiye)

T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi

Istanbul, , Turkey (Türkiye)

Pendik Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Ege University

Izmir, , Turkey (Türkiye)

Dokuz Eylul Universitesi Tip Fakultesi

Izmir, , Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, , Turkey (Türkiye)

Inonu Universitesi Turgut Ozal Tip Merkezi, Ic Hastaliklari

Malatya, , Turkey (Türkiye)

Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

Dnipro, , Ukraine

Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

Dnipro, , Ukraine

MI Dnipropetrovsk Region Clinical Hospital n a I.I.Mechnikov

Dnipropetrovsk, , Ukraine

Ivano-Frankivsk Regional Clinical Hospital

Ivano-Frankivsk, , Ukraine

Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval

Kharkiv, , Ukraine

Municipal non-profit enterprise 'Regional Center of Oncology'

Kharkiv, , Ukraine

National Cancer Institute

Kyiv, , Ukraine

State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

Kyiv, , Ukraine

Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

Lviv, , Ukraine

Transkarpathian Regional University Oncology Clinic

Uzhhorod, , Ukraine

Podilskiy Regional Center of Oncology

Vinnitsa, , Ukraine

Zaokod

Zaporizhzhia, , Ukraine

Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital

Zaporizhzhia, , Ukraine

University Hospitals Bristol - Bristol Haematology & Oncolog

Bristol, , United Kingdom

St Bartholomew's Hospital

London, , United Kingdom

Sarah Cannon Research Institute

London, , United Kingdom

Charing Cross Hospital

London, , United Kingdom

The Christie NHS Foundation Trust Christie Hospital

Manchester, , United Kingdom

Derriford Hospital-Department of Medical Oncology

Plymouth, , United Kingdom

University of Sheffield

Sheffield, , United Kingdom

Southampton General Hospital

Southampton, , United Kingdom

Royal Marsden Hospital

Sutton, , United Kingdom

Countries

Czechia; Denmark; India; Lebanon; Thailand; United States; Argentina; Australia; Austria; Belgium; Brazil; Bulgaria; Canada; China; France; Germany; Greece; Hungary; Israel; Italy; Japan; Mexico; Netherlands; Poland; Portugal; Russia; South Korea; Spain; Taiwan; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37870920 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

42756493BLC3001

Identifier Type: OTHER

Identifier Source: secondary_id

2017-002932-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-510296-56-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR108401

Identifier Type: -

Identifier Source: org_study_id