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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Urothelial Cancer
• Intervention / Treatment: Drug: Erdafitinib; Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA); Drug: Vinflunine; Drug: Docetaxel; Drug: Pembrolizumab

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.

• Study Type: Interventional
• Enrollment (Actual): 629
• Phase: Phase 3

Expanded Access

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Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426AGE
    • Centro Oncologico Korben
  • Buenos Aires, Argentina, C1419AHN
    • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
  • Buenos Aires, Argentina, C1431FWN
    • CEMIC Saavedra
  • Córdoba, Argentina, X5000KPH
    • Centro Urologico Profesor Bengio
  • Córdoba, Argentina, C5000
    • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • Mar del Plata, Argentina, B7602CBM
    • Hospital Privado de Comunidad
  • Pergamino, Argentina, B2700CPM
    • Centro de Investigación Pergamino SA
  • Viedma, Argentina, R8500ACE
    • Clínica Viedma
• Australia
  • Camperdown, Australia, 2050
    • Chris O'Brien Lifehouse
  • Frankston, Australia, 3199
    • Peninsula & South Eastern Haematology and Oncology Group
  • Kogarah, Australia, 2217
    • St George Hospital
  • Melbourne, Australia, 3000
    • Peter Maccallum Cancer Centre
  • Melbourne, Australia, 3199
    • Frankston Hospital
  • Murdoch, Australia, 6150
    • Fiona Stanley Hospital
• Austria
  • Graz, Austria, 8036
    • Lkh-Univ. Klinikum Graz
  • Linz, Austria, 4020
    • Ordensklinikum Linz GmbH Elisabethinen
  • Salzburg, Austria, 5020
    • Lkh - Universitatsklinikum Der Pmu Salzburg
  • Vienna, Austria, 1020
    • Krankenhaus der Barmherzigen Brüder
  • Vienna, Austria, A-1090
    • Medical University Vienna MUV
• Belgium
  • Aalst, Belgium, 9300
    • OLV Ziekenhuis Aalst
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint Luc
  • Charleroi, Belgium, 6000
    • Clinique Notre Dame de Grâce
  • Ghent, Belgium, 9000
    • AZ Maria Middelares
  • Ghent, Belgium, 9000
    • UZ Gent
  • Liège, Belgium, 4000
    • CHC MontLegia
  • Wilrijk, Belgium, 2610
    • Sint-Augustinus AZ
  • Yvoir, Belgium, 5530
    • CHU UCL Namur - Site Godinne
• Brazil
  • Barretos, Brazil, 14784-400
    • Fundação Pio XII
  • Belo Horizonte, Brazil, 30130-100
    • Universidade Federal De Minas Gerais - Hospital das Clínicas
  • Belo Horizonte, Brazil, 30380-472
    • Nucleo de Ensino e Pesquisa do Instituto Mario Penna
  • Curitiba, Brazil, 80530-010
    • Instituto de Oncologia do Parana
  • Curitiba, Brazil, 81520 060
    • Liga Paranaense de Combate ao Cancer
  • Goiânia, Brazil, 74605-070
    • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
  • Itajaí, Brazil, 88301-220
    • Clínica de Neoplasias Litoral Ltda.
  • Jaú, Brazil, 17210 080
    • Fundação Doutor Amaral Carvalho
  • Natal, Brazil, 59075-740
    • Liga Norte Riograndense Contra o Câncer
  • Porto Alegre, Brazil, 90035-903
    • Hospital das Clinicas de Porto Alegre
  • Porto Alegre, Brazil, 91350 200
    • Hospital Nossa Senhora da Conceicao S A
  • Rio de Janeiro, Brazil, 22250 905
    • Oncoclinicas Rio de Janeiro S A
  • Rio de Janeiro, Brazil, 20231 050
    • Ministerio da Saude Instituto Nacional do Cancer
  • Salvador, Brazil, 41253-190
    • Hospital Sao Rafael
  • Santo André, Brazil, 09060-650
    • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
  • Sorocaba, Brazil, 18030-005
    • Instituto de Oncologia de Sorocaba Onco Clinicas Especializadas
  • São José do Rio Preto, Brazil, 15090-000
    • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base
  • São Paulo, Brazil, 04502-001
    • Instituto D Or de Pesquisa e Ensino IDOR
  • São Paulo, Brazil, 01509 900
    • Fundacao Antonio Prudente A C Camargo Cancer Center
  • São Paulo, Brazil, 05652 900
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 03102-002
    • Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia
  • São Paulo, Brazil, 01308 050
    • Sociedade Beneficente de Senhoras Hospital Sirio Libanes 1
• Bulgaria
  • Pleven, Bulgaria, 5800
    • UMHAT 'Dr. Georgi Stranski', EAD
  • Plovdiv, Bulgaria, 4004
    • Complex Oncology Center - Plovdiv EOOD
  • Sofia, Bulgaria, 1407
    • Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'
  • Sofia, Bulgaria, 1797
    • UMHAT Sofia Med
  • Varna, Bulgaria, 9010
    • Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD
• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • BC Cancer Agency - Southern Interior
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Vancouver Cancer Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba
  • Ontario
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Thunder Bay Regional Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital- UHN
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre
• China
  • Beijing, China, 100730
    • Beijing Hospital
  • Beijing, China, 100730
    • Peking Union Medical College Hospital
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100050
    • Beijing Friendship Hospital
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences
  • Changchun, China, 130021
    • The First Bethune Hospital of Jilin University
  • Chengdu, China, 610041
    • Sichuan University Huaxi Hospital
  • Chengdu, China, 610000
    • Sichuan Provincial Peoples Hospital
  • Chongqing, China, 400030
    • Chongqing University Cancer Hospital
  • Guangzhou, China, 510180
    • Guangzhou First Municipal People's Hospital
  • Guangzhou, China, 510120
    • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Guangzhou, China, 510060
    • Sun Yat Sen University Cancer Center
  • Hangzhou, China, 310014
    • Zhejiang Provincial People's Hospital
  • Hangzhou, China, 310020
    • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  • Nanchang, China, 330006
    • The First Affliated Hospital Of Nanchang University
  • Nanjing, China, 210009
    • Jiangsu Cancer Hospital
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Shanghai, China, 200127
    • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai, China, 200400
    • Huadong Hospital affiliated to Fudan University
  • Shenyang, China, 110004
    • Shengjing Hospital of China Medical University
  • Shenzhen, China, 518055
    • Shenzhen University General Hospital
  • Wenzhou, China, 325000
    • First Affiliated Hospital Of Wenzhou Medical College
  • Xi'an, China, 710061
    • The First Affiliated Hospital of Xian Jiaotong University
• France
  • Angers, France, 49055
    • Institut de Cancerologie de l Ouest ICO
  • Besançon, France, 25030
    • Hôpital Jean Minjoz
  • Bordeaux, France, 33000
    • Institut Bergonie
  • Brest, France, 29609
    • CHRU Brest - Hopital Morvan
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Dijon, France, 21079
    • Centre Georges-Francois Leclerc
  • Lille, France, 59000
    • Centre Oscar Lambret
  • Lille, France, 59000
    • Hopital prive Le Bois
  • Lorient, France, 56322
    • Groupe Hospitalier Bretagne Sud
  • Marseille, France, 13005
    • Hôpital de la Timone
  • Montpellier, France, 34298
    • Institut Regional du Cancer de Montpellier Val d'Aurelle
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Nîmes, France, 30029
    • Institut de cancerologie du Gard
  • Paris, France, 75015
    • Hôpital Européen Georges-Pompidou
  • Paris, France, 75475
    • Hospital Saint-Louis
  • Pierre-Bénite, France, 69495
    • Hospices Civils de Lyon HCL
  • Poitiers, France, 86021
    • CHU de Poitiers
  • Rennes, France, 35062
    • Centre Eugène Marquis
  • Ris-Orangis, France, 91130
    • Centre de radiothérapie et d'Oncologie médicale de l'Essonne
  • Saint-Priest-en-Jarez, France, 42271
    • Institut de Cancérologie de Loire
  • Strasbourg, France, 67098
    • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
  • Toulouse, France, 31059
    • Institut Claudius Regaud
  • Valenciennes, France, 59300
    • Centre Les Dentellieres
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Germany
  • Berlin, Germany, 10967
    • Vivantes Klinikum Am Urban
  • Braunschweig, Germany, 38126
    • Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carcus Dresden
  • Düsseldorf, Germany, 40225
    • Universitaetsklinikum Duesseldorf
  • Erlangen, Germany, 91054
    • Friedrich-Alexander Universitaet Urologische Universitaetskl
  • Frankfurt, Germany, 60590
    • Universitätsklinikum Frankfurt
  • Freiburg im Breisgau, Germany, 79106
    • Universitätsklinikum Freiburg
  • Greifswald, Germany, 17475
    • Universitätsmedizin Greifswald
  • Göttingen, Germany, 37099
    • Universitätsmedizin Göttingen
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Lübeck, Germany, 23538
    • Universitatsklinikum Schleswig Holstein Campus Lubeck
  • Mannheim, Germany, 68167
    • Medizinische Fakultät Mannheim der Universität Heidelberg
  • Münster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Nürtingen, Germany, 72622
    • Studienpraxis Urologie Drs. Feyerabend
  • Regensburg, Germany, 93053
    • Caritas-Krankenhaus St. Josef
  • Rostock, Germany, 18057
    • Universitaetsmedizin Rostock
  • Velbert, Germany, 42551
    • MVZ-Onkologie Velbert GbR
  • Weiden, Germany, 92637
    • Kliniken Nordoberpfalz AG/Klinikum Weiden
• Greece
  • Athens, Greece, 15125
    • Athens Medical Center
  • Athens, Greece, 11526
    • Errikos Dunant Hospital Center
  • Athens, Greece, 15562
    • Metropolitan General A E
  • Athens, Greece, 115 28
    • University of Athens Medical School - Regional General Hospi
  • Larissa, Greece, 41110
    • University Hospital of Larissa
  • Pátrai, Greece, 26504
    • University General Hospital of Rio Patras
  • Thessaloniki, Greece, 56403
    • Papageorgiou General Hospital of Thessaloniki
  • Thessaloniki, Greece, 54645
    • Euromedica General Clinic
  • Thessaloniki, Greece, 14564
    • Interbalkan European Medical Center
• Hungary
  • Budapest, Hungary, 1082
    • Semmelweis Egyetem
  • Budapest, Hungary, 1122
    • Országos Onkológiai Intézet, Urogenitális Tumorok és Klinikai Farmakológiai Osztály
  • Budapest, Hungary, H-1145
    • Budapesti Uzsoki Utcai Korhaz
  • Nyíregyháza, Hungary, 04400
    • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
  • Pécs, Hungary, 7624
    • Pecsi Tudomanyegyetem Klinikai Kozpont
• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center
  • Kfar Saba, Israel, 44281
    • Meir Medical Center
  • Petach Tikvah, Israel, 49100
    • Rabin Medical Center, Beilinson Hospital
  • Tel Aviv, Israel, 64239
    • Sourasky Medical Center
  • Tel Litwinsky, Israel, 52621
    • The Chaim Sheba Medical Center
  • Tzrifin, Israel, 70300
    • Assaf Harofeh Medical Center
• Italy
  • Alessandria, Italy, 15121
    • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
  • Arezzo, Italy, 52100
    • Ospedale S. Donato - Asl 8 Arezzo
  • Aviano, Italy, 33081
    • CRO IRCCS Istituto Nazionale Tumori
  • Bergamo, Italy, 24127
    • Azienda Ospedaliera Papa Giovanni XXIII
  • Brescia, Italy, 25123
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
  • Cremona, Italy, 26100
    • Istituti Ospitalieri di Cremona, AO di Cremona
  • Florence, Italy, 50139
    • Oncologia Medica
  • Genova, Italy
    • SPDC Villa Scassi
  • Meldola, Italy, 47014
    • IRST Meldola Forli
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Milan, Italy, 20141
    • European Institute of Oncology
  • Milan, Italy, 20132
    • IRCCS Ospedale San Raffaele
  • Modena, Italy, 41124
    • AOU Policlinico di Modena
  • Naples, Italy, 80131
    • IRCCS-Fondazione Pascale
  • Novara, Italy, 28100
    • Ospedale Maggiore Della Carita
  • Orbassano, Italy, 10043
    • AOU San Luigi Gonzaga
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto Iov Irccs Padova
  • Parma, Italy, 43126
    • AOU di Parma
  • Pavia, Italy, 27100
    • IRCCS Policlinico San Matteo
  • Pavia, Italy, 27100
    • Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncolo
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana
  • Poggibonsi (SI), Italy, 53100
    • Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST
  • Province of Macerata, Italy, 62100
    • UOC Oncologia Ospedale Provinciale di Macerata
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A Gemelli IRCCS
  • Siena, Italy, 53100
    • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
  • Torino, Italy, 10123
    • Oncologia Medica-Città Della Salute E Della Scienza Di Torino
  • Torrette Di Ancona, Italy, 60126
    • Azienda Ospedaliero - Universitaria Ospedali Riuniti
• Japan
  • Chiba, Japan, 260-8717
    • Chiba Cancer Center
  • Hirosaki, Japan, 036-8563
    • Hirosaki University Hospital
  • Kashiwa, Japan, 277 8577
    • National Cancer Center Hospital East
  • Kita Gun, Japan, 761 0793
    • Kagawa University Hospital
  • Kobe, Japan, 650-0047
    • Kobe City Medical Center General Hospital
  • Koshigaya, Japan, 343-8555
    • Dokkyo Medical University Saitama Medical Center
  • Matsuyama, Japan, 791-0280
    • Aso Co.,Ltd Iizuka Hospital
  • Miyazaki, Japan, 889-1692
    • University of Miyazaki Hospital
  • Nagano, Japan, 381-8551
    • Nagano Municipal Hospital
  • Nagoya, Japan, 464 8681
    • Aichi Cancer Center Hospital
  • Osaka, Japan, 545 8586
    • Osaka City University Hospital
  • Osaka, Japan, 541 8567
    • Osaka International Cancer Institute
  • Sagamihara, Japan, 252-0375
    • Kitasato University Hospital
  • Sakura, Japan, 285-8741
    • Toho University Sakura Medical Center
  • Sapporo, Japan, 003-0804
    • National Hospital Organization Hokkaido Cancer Center
  • Shinjuku-ku, Japan, 162-8666
    • Tokyo Women's Medical University Hospital
  • Tokyo, Japan, 105-8470
    • Toranomon Hospital
  • Tokyo, Japan, 135 8550
    • The Cancer Institute Hospital of JFCR 1
  • Tsukuba, Japan, 305 8576
    • University of Tsukuba Hospital
  • Ube, Japan, 755-8505
    • Yamaguchi University Hospital
  • Yokohama, Japan, 232 0024
    • Yokohama City University Medical Center
  • Ōsaka-sayama, Japan, 589-8511
    • Kindai University Hospital
  • Ōta-ku, Japan, 373 8550
    • Gunma Prefectural Cancer Center
• Mexico
  • Aguascalientes, Mexico, 20230
    • Medicos Especialistas en Cancer, S.C.
  • Chihuahua City, Mexico, 31000
    • Centro Estatal de Cancerologia de Chihuahua
  • Naucalpan, Mexico, 53100
    • Oncología Integral Satélite
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Antoni van Leeuwenhoek
  • Nieuwegein, Netherlands, 3430 EM
    • St. Antonius Ziekenhuis Nieuwegein
  • The Hague, Netherlands, 2545 CH
    • Haga Ziekenhuis
• Poland
  • Bydgoszcz, Poland, 85 796
    • Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
  • Warsaw, Poland, 02-507
    • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Warsaw, Poland, 02-781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
  • Wroclaw, Poland, 50 556
    • Uniwersytecki Szpital Kliniczny we Wroclawiu
• Portugal
  • Lisbon, Portugal, 1400-038
    • Champalimaud Foundation Champalimaud Centre
  • Lisbon, Portugal, G1R 2J6
    • Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
  • Lisbon, Portugal, 1500-458
    • Hospital Lusíadas
  • Lisbon, Portugal, 1649-035
    • H. Santa Maria - Centro Hospitalar de Lisboa Norte
  • Porto, Portugal, 4200072
    • Instituto Portugues de Oncologia
• Russia
  • Barnaul, Russia, 656049
    • Altai Regional Oncology Dispensary
  • Chelyabinsk, Russia, 454087
    • Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
  • Irkutsk, Russia, 664035
    • Irkutsk Regional Oncology Dispensary
  • Ivanovo, Russia, 153040
    • Ivanovo regional oncology dispensary
  • Kostroma, Russia, 156005
    • Kostroma regional oncology dispensary
  • Kuzmolovsky, Russia, 188663
    • Leningrad Regional Oncology Dispensary
  • Moscow, Russia, 105077
    • City Clinical Hospital n.a. D.D.Pletnev
  • Moscow, Russia, 117997
    • Russian Scientific Center of Roentgenoradiology
  • Moscow, Russia, 119991
    • I.M. Sechenov First Moscow State Medical University
  • Moscow, Russia, 125284
    • Hertzen Oncology Research Institute
  • Moscow, Russia, 115478
    • FSBSI 'N. N. Blokhin Russian Cancer Research Center'
  • Nal'chik, Russia, 360017
    • City Clinical Hospital #1
  • Nizhny Novgorod, Russia, 603109
    • Privolzhsky District Medical Center under the Federal Medico-Biological Agency
  • Omsk, Russia, 644013
    • Clinical Oncology Dispensary
  • Pyatigorsk, Russia, 357502
    • GBUZ of Stavropol region Pyatigorsk Oncological Dispensary
  • Saint Petersburg, Russia, 196603
    • Private Medical Institution Euromedservice
  • Saint Petersburg, Russia, 197758
    • Russian Scientific Center of Radiology and Surgical Technologies
  • Saint Petersburg, Russia, 192148
    • LLC 'Strategic Medical Systems'
  • Saint Petersburg, Russia, 195067
    • Clinical hopital n/a Petra velikogo
  • Saint Petersburg, Russia, 197022
    • Pavlov First Saint Petersburg State Medical University
  • Saint Petersburg, Russia, 197758
    • Saint-Petersburg Clinical Scientific And Practical Center For Special Types Of Medical Care
  • Saransk, Russia, 430032
    • FGBOU Vo Mordovian National Research State University N. A. N.P. Ogareva
  • Saratov, Russia, 410000
    • Saratov State Medical University
  • Smolensk, Russia, 214031
    • LLC Uromed
  • Sochi, Russia, 354057
    • GBUZ Oncology Centre #2 of Healthcare Department of Krasno
  • Tyumen, Russia, 625041
    • Multifunctional clinical medical center 'Medical city'
  • Ufa, Russia, 450000
    • Bashkiria State Medical University
  • Vologda, Russia, 160012
    • Vologda Regional Oncological Dispensary
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Daejeon, South Korea, 35015
    • Chungnam National University Hospital
  • Goyang-si, South Korea, 410-769
    • National Cancer Center
  • Gwangju, South Korea, 61469
    • Chonnam National University Hospital
  • Gyeonggi-do, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Incheon, South Korea, 21565
    • Gachon University Gil Medical Center
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
  • Seoul, South Korea, 135-710
    • Samsung Medical Center
  • Wŏnju, South Korea, 26426
    • Yonsei University Wonju Severance Christian Hospital
• Spain
  • Badajoz, Spain, 06006
    • Hosp. Univ. Infanta Cristina
  • Badalona, Spain, 08916
    • Institut Català D'Oncologia-Hospital Universitari Germans Trias I Pujol
  • Barcelona, Spain, 08041
    • Hosp. de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08036
    • Hosp Clinic de Barcelona
  • Cáceres, Spain, 10003
    • Hosp. San Pedro de Alcantara
  • Córdoba, Spain, 14004
    • Hosp Reina Sofia
  • Granada, Spain, 18014
    • Hosp. Univ. Virgen de Las Nieves
  • Jaén, Spain, 23007
    • Complejo Hospitalario de Jaén
  • Las Palmas de Gran Canaria, Spain, 35016
    • Hosp. Univ. Insular de Gran Canaria
  • Lugo, Spain, 27003
    • Hosp. Univ. Lucus Augusti
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28046
    • Hosp. Univ. La Paz
  • Majadahonda, Spain, 28220
    • Hosp. Univ. Pta. de Hierro Majadahonda
  • Manresa, Spain, 08243
    • Althaia, Xarxa Assistencial Universitària de Manresa
  • Pamplona, Spain, 31008
    • Hosp. de Navarra
  • Seville, Spain, 41013
    • Hosp. Virgen Del Rocio
  • Seville, Spain, 41009
    • Hosp. Virgen Macarena
  • Valencia, Spain, 46014
    • Hosp. Gral. Univ. Valencia
  • Valencia, Spain, 46026
    • Hosp. Univ. I Politecni La Fe
  • Zaragoza, Spain, 50009
    • Hosp. Univ. Miguel Servet
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung Ho Memorial Hospital
  • Niao-Sung Hsiang, Taiwan, 833
    • Chang Gung Medical Foundation
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Tainan, Taiwan, 710
    • Chi Mei Medical Center Yong Kang
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei, Taiwan, 11259
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taoyuan, Taiwan, 333
    • Chang-Gung Memorial Hospital, Linkou Branch
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01120
    • Baskent University Adana Practice and Research Center Kisla Health Campus
  • Ankara, Turkey (Türkiye), 6100
    • Hacettepe University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul Universitesi Cerrahpasa Tip Fakultesi
  • Istanbul, Turkey (Türkiye), 34147
    • Bakirkoy Training and Research Hospital
  • Istanbul, Turkey (Türkiye), 34722
    • T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
  • Istanbul, Turkey (Türkiye), 34214
    • Medipol Mega University Hospital
  • Istanbul, Turkey (Türkiye), 34093
    • Bezmialem University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34890
    • Pendik Training and Research Hospital
  • Izmir, Turkey (Türkiye), 35340
    • Dokuz Eylul Universitesi Tip Fakultesi
  • Izmir, Turkey (Türkiye), 35100
    • Ege University
  • Kocaeli, Turkey (Türkiye)
    • Kocaeli University Medical Faculty
  • Malatya, Turkey (Türkiye), 44400
    • Inonu Universitesi Turgut Ozal Tip Merkezi, Ic Hastaliklari
• Ukraine
  • Dnipro, Ukraine, 49102
    • Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
  • Dnipro, Ukraine, 49100
    • Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
  • Dnipropetrovsk, Ukraine, 49005
    • MI Dnipropetrovsk Region Clinical Hospital n a I.I.Mechnikov
  • Ivano-Frankivsk, Ukraine, 76008
    • Ivano-Frankivsk Regional Clinical Hospital
  • Kharkiv, Ukraine, 61070
    • Municipal non-profit enterprise 'Regional Center of Oncology'
  • Kharkiv, Ukraine, 61037
    • Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
  • Kyiv, Ukraine, 03022
    • National Cancer Institute
  • Kyiv, Ukraine, 03115
    • State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
  • Lviv, Ukraine, 79010
    • Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
  • Uzhhorod, Ukraine, 88000
    • Transkarpathian Regional University Oncology Clinic
  • Vinnitsa, Ukraine, 21029
    • Podilskiy Regional Center of Oncology
  • Zaporizhzhia, Ukraine, 69040
    • Zaokod
  • Zaporizhzhia, Ukraine, 69600
    • Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital
• United Kingdom
  • Bristol, United Kingdom, BS2 8ED
    • University Hospitals Bristol - Bristol Haematology & Oncolog
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • London, United Kingdom, EC1A 7BE
    • St Bartholomew's Hospital
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust Christie Hospital
  • Plymouth, United Kingdom, PL6 8QH
    • Derriford Hospital-Department of Medical Oncology
  • Sheffield, United Kingdom, S10 2 RX
    • University of Sheffield
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
  • Sutton, United Kingdom, SM2 5NG
    • Royal Marsden Hospital
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99503
      • Alaska Urological Institute dba Alaska Clinical Research Center
  • California
    • Sacramento, California, United States, 95817
      • University of Calif Davis Medical Center
    • St. Helena, California, United States, 94574
      • St. Helena Hospital - Martin-O'Neil Cancer Center
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Sylvester Cancer Center
    • Orange, Florida, United States, 32763
      • Mid Florida Hematology Oncology
  • Georgia
    • Atlanta, Georgia, United States, 30318-0922
      • Piedmont Cancer Institute
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University
    • Hines, Illinois, United States, 60141
      • Edward Hines Jr V A Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute
  • Maryland
    • Lanham, Maryland, United States, 20706
      • Maryland Oncology Hematology, PA
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5000
      • University of Michigan Health System
  • Nevada
    • Reno, Nevada, United States, 89509
      • VA Sierra Nevada Health Care System
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New York
    • New York, New York, United States, 10029
      • Weill Cornell Medical College
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute, Carolinas HealthCare System
    • Salisbury, North Carolina, United States, 28144
      • W G Bill Hefner VA Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care
  • Texas
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer and Blood Disorders
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • Houston, Texas, United States, 77024
      • Texas Oncology-Memorial City
    • Tyler, Texas, United States, 75702
      • Texas Oncology Tyler
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • INOVA Dwiight &Martha Schar Cancer Institute
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Erdafitinib; Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.; Other Names: JNJ-42756493; Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA); FGFRi CTA will be used to determine molecular eligibility.
Experimental: 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.	Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA); FGFRi CTA will be used to determine molecular eligibility.; Drug: Vinflunine; Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.; Drug: Docetaxel; Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.
Experimental: 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.	Drug: Erdafitinib; Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.; Other Names: JNJ-42756493; Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA); FGFRi CTA will be used to determine molecular eligibility.
Experimental: 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.	Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA); FGFRi CTA will be used to determine molecular eligibility.; Drug: Pembrolizumab; Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	PFS was defined as the time from the date of randomization to the date of disease progression or relapse from complete response (CR) based on investigator assessment using RECIST v 1.1, or death due to any cause, whichever occurred first. As per RECIST v 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (<) 10 millimeters (mm). Progressive disease (PD) was defined as at least 20 percent (%) increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of greater than or equal to (>=) 5 mm or appearance of at least 1 new lesion.	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	ORR was defined as the percentage of participants who achieved CR or partial response (PR) as determined by investigator per RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	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)	The FACT-Bl consisted of 39 items, with 5-point Likert scales, covering 5 primary domains: physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns for participants with bladder cancer. The response options ranged from 0 to 4 where, 0='Not at all" and 4= "very much." FACT-Bl total score ranged from 0 (worst) to 156 (best). The higher the score, the better the quality of life (QOL). The baseline value was defined as the value collected at the time closest to but prior to the randomization.	Baseline up to Cycle 11 (each cycle was of 21 days)
Time Until Symptom Deterioration	Time until symptom deterioration was defined as the first time to increase in urinary bladder cancer symptoms score from the day of randomization beyond a meaningful change threshold compared to baseline. The urinary bladder cancer symptom score was subset of FACT-Bl which included 3 items related to urinary symptoms, 5-point Likert scale. Response options ranged from 0 to 4, 0 = Not at all, 1= A little bit, 2= Somewhat, 3=Quite a bit, 4 = Very much. A response of 0 indicated no symptoms and 4 indicated severe symptoms. Total sum scores ranged from 0 to 12, higher scores indicate relatively poor quality of life.	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)	The PGI-S was a single item patient-reported measure assessing participants' impression of severity in bladder cancer symptoms. It uses a 4-point Likert scale as follows: symptoms are: 0-"absent (no symptoms)", 1-"mild", 2-"moderate", 3="severe" and 4= "very severe". Percentage of participants with shift from baseline in PGIS score were reported. A negative shift from baseline in PGIS score indicated Improvement and positive shift from baseline in PGIS score indicated Worsening. The baseline value was defined as the value collected at the time closest to but prior to the randomization.	Baseline, 51.7 months
Change From Baseline in Utility Scale of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)	The EQ-5D-5L was a generic measure of health status. The EQ-5D-5L was a 5-item questionnaire that assessed 5 domains included mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Health utility values generated from the EQ-5D generally range from 0 (a state as bad as being dead) to 1 (full health), with higher scores indicating better QoL. The EQ visual analog scale (VAS) recorded the patient's self-rated health on a VAS, ranged from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better QoL. The baseline value was defined as the value collected at the time closest to but prior to the randomization.	Baseline up to Cycle 11 (each cycle was of 21 days)
Change From Baseline in Visual Analog Scale (VAS) of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)	The EQ-5D-5L was a generic measure of health status. The EQ-5D-5L was a 5-item questionnaire that assessed 5 domains included mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Health utility values generated from the EQ-5D generally range from 0 (a state as bad as being dead) to 1 (full health), with higher scores indicating better QoL. The EQ VAS recorded the patient's self-rated health on a VAS, ranged from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better QoL. The baseline value was defined as the value collected at the time closest to but prior to the randomization.	Baseline up to Cycle 11 (each cycle was of 21 days)
Duration of Response (DOR) as Per RECIST Version 1.1	DOR was defined as time from the date of initial documentation of an overall response (CR or PR) to the date of first documented evidence of progressive disease (PD) (or relapse for participants who experience CR) or death. As per RECIST Version 1.1: CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion.	From date of first documented response to date of first documented PD or death whichever occurred first (maximum up to 51.7 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were the events between first dose of study drug and up to 30 days after last dose or before start of new anticancer therapy, whichever occurred first. All TEAEs including serious and non-serious events were reported in this outcome measure.	From start of the treatment (Day 1 Cycle 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy (maximum up to 51.7 months)
Number of Participants With Shift From Baseline Grade Less Than or Equal to (<=) 2 to Grade Greater Than or Equal to (>=) 3 Post-Baseline in Laboratory Parameter: Hematology	Hematology parameters included: hemoglobin, platelet count, white blood cell (WBC) count, and absolute neutrophil count (ANC). According to national cancer institute (NCI)-common terminology criteria for adverse events (CTCAE) version 4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE and Grade 0= normal. In this outcome measure number of participants with shifts from baseline (BL) Grade <= 2 to Grade >=3 post-baseline in any of hematology parameters are reported. The baseline value for safety assessment was defined as the value collected at the time closest to, but prior to, the administration of the first dose of study drug. Only those categories in which at least one participant had data were reported in this outcome measure.	From baseline up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (maximum up to 51.7 months)
Number of Participants With Shift From Baseline Grade <= 2 to Grade >=3 Post-Baseline in Laboratory Parameter: Chemistry	Chemistry parameters included: albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, chloride, creatinine, bicarbonate, corrected calcium, magnesium, potassium, sodium, serum phosphate, serum parathyroid hormone. According to NCI-CTCAE version 4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE and Grade 0= normal. In this outcome measure number of participants with shifts from baseline (BL) Grade <= 2 to Grade >=3 post-baseline in any of chemistry parameters are reported. The baseline value for safety assessment was defined as the value collected at the time closest to, but prior to, the administration of the first dose of study drug. Only those categories in which at least one participant had data were reported in this outcome measure.	From baseline up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (maximum up to 51.7 months)
Number of Participants With Abnormalities in Electrocardiograms (ECG) Parameters	Number of participants with abnormalities in ECG parameters were reported. The ECG variables included heart rate, RR interval, PR interval, QRS interval, QT interval and QT corrected according to Fridericia's formula (QTcF). ECG abnormality criteria include: Heart rate: Low <50 beats per minute (bpm); High > 100 bpm, RR interval: Low < 600 milliseconds (ms); High > 1000 ms, QT interval: High > 500 ms, QTc interval: High > (450 ms for males, 470 ms for females); increase to >500 ms.	Day 1 of Cycle 2 and 4 (Each Cycle 21 days)
Change From Baseline in Vital Signs: Weight	Changes from baseline in vital signs (weight) was reported. The baseline value for safety assessment was defined as the value collected at the time closest to, but prior to, the administration of the first dose of study drug.	Baseline, 51.7 months
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Amsler Grid Test	Number of participants with shift from baseline to worst post-baseline in Amsler grid test was reported. Baseline and post-baseline visit findings included normal, abnormal CS (clinically significant) and abnormal NCS (not clinically significant). Clinical significance was determined by investigator's assessment. The baseline value for safety assessment was defined as the value collected at the time closest to, but prior to, the administration of the first dose of study drug. Only categories in which at least one participant had data for worsening post-baseline measurement was reported.	From baseline up to maximum of 51.7 months
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Visual Acuity	Number of participants with shift from baseline to worst post-baseline in visual acuity (VA) was reported. Worst post-baseline was defined as the visual acuity value that resulted in the largest change from baseline value for either eye. Baseline value was considered for the eye that reported the worst-post baseline value. Baseline and post-baseline visit visual acuity findings included: <= 20/30, >20/30 to <= 20/40, >20/40 to <= 20/80, >20/80 to <= 20/120, >20/120 to <= 20/160, >20/160 to <= 20/200, >20/200. The baseline value for safety assessment was defined as the value collected at the time closest to, but prior to, the administration of the first dose of study drug. Only categories in which at least one participant had data for worsening in visual acuity from baseline value to worst post-baseline measurement was reported.	From baseline up to maximum of 51.7 months
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Optical Coherence Tomography: Subretinal Fluid	Number of participants with shift from baseline to worst post-baseline in optical coherence tomography for subretinal fluid was reported. At the baseline visit, findings may have been absent or present/visible. At all post-baseline visits, findings were compared to baseline and results may have been increased, decreased, stable or resolved. The baseline value for safety assessment was defined as the value collected at the time closest to, but prior to, the administration of the first dose of study drug. Only category (shift from absent at baseline to increased at post-baseline) in which at least one participant had data for worsening post-baseline measurement was reported.	From baseline up to maximum of 51.7 months
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Optical Coherence Tomography: Retinal Pigment Epithelium (RPE) Elevation	Number of participants with shift from baseline to worst post-baseline in optical coherence tomography for RPE elevation was reported. At the baseline visit, findings may have been absent or present/visible. At all post-baseline visits, findings were compared to baseline and results may have been increased, decreased, stable or resolved. The baseline value for safety assessment was defined as the value collected at the time closest to, but prior to, the administration of the first dose of study drug. Only categories in which at least one participant had data for worsening post-baseline measurement was reported.	From baseline up to maximum of 51.7 months
Number of Participants With Shift From Baseline to Worst Post-baseline Ophthalmologic Examination: Slit Lamp Biomicroscopy: Retinal Assessment	Number of participants with shift from baseline to worst post-baseline in slit lamp biomicroscopy examination for retinal assessment was reported. Baseline and post-baseline visit findings included normal, abnormal CS and abnormal NCS. Clinical significance was determined by investigator's assessment. The baseline value for safety assessment was defined as the value collected at the time closest to, but prior to, the administration of the first dose of study drug. Only categories in which at least one participant had data for worsening post-baseline measurement was reported.	From baseline up to maximum of 51.7 months
Oral Clearance (CL/F) of Erdafitinib	Clearance was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.	Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle was of 21 days)
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of Erdafitinib	Area under the plasma concentration time-curve from time zero to the time t (AUC[0-t]) was reported.	Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle is of 21 days)

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2018
• Primary Completion (Actual): April 15, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (Actual): January 4, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; pembrolizumab; erdafitinib; vinflunine
• Other Study ID Numbers: CR108401; 2017-002932-18 (EudraCT Number); 42756493BLC3001 (Other Identifier: Janssen Research & Development, LLC); 2023-510296-56-00 (Registry Identifier: EUCT number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes