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 Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1419AHN
    • Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
  • Buenos Aires, Argentina, C1426AGE
    • Centro Oncologico Korben
  • Ciudad Autonoma de Buenos Aires, Argentina, C1431FWN
    • CEMIC Saavedra
  • Cordoba, Argentina, X5000KPH
    • Centro Urológico Profesor Bengió
  • Cordoba, 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 Investigacion Pergamino SA
  • Viedma, Argentina, R8500ACE
    • Clinica 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 - Universitätsklinikum 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
  • Antwerpen, Belgium, 2020
    • ZNA Middelheim
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires Saint Luc
  • Charleroi, Belgium, 6000
    • Clinique Notre Dame de Grâce
  • Gent, Belgium, 9000
    • UZ Gent
  • Gent, Belgium, 9000
    • AZ Maria Middelares
  • Liege, 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, 81520-060
    • Liga Paranaense de Combate ao Cancer
  • Curitiba, Brazil, 80530-010
    • Instituto de Oncologia do Parana
  • Goiania, Brazil, 74605-070
    • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
  • Itajai, Brazil, 88301-220
    • Clínica de Neoplasias Litoral Ltda.
  • Jau, Brazil, 17210-080
    • Fundacao Doutor Amaral Carvalho
  • Natal, Brazil, 59075-740
    • Liga Norte Riograndense Contra O Câncer
  • Porto Alegre, Brazil, 90035-903
    • Hospital das Clínicas de Porto Alegre
  • Porto Alegre, Brazil, 91350-200
    • Hospital Nossa Senhora da Conceicao S A
  • Rio De Janeiro, Brazil, 20231-050
    • Ministerio da Saude - Instituto Nacional do Cancer
  • Rio de Janeiro, Brazil, 22250 905
    • Oncoclinicas Rio de Janeiro S A
  • Salvador, Brazil, 41253-190
    • Hospital Sao Rafael
  • Santo Andre, Brazil, 09060-650
    • CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
  • Sao Jose do Rio Preto, Brazil, 15090-000
    • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
  • Sao Paulo, Brazil, 03102-002
    • Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia
  • Sao Paulo, Brazil, 01509 900
    • Fundacao Antonio Prudente A C Camargo Cancer Center
  • Sorocaba, Brazil, 18030-005
    • Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas
  • São Paulo, Brazil, 01308-901
    • Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
  • São Paulo, Brazil, 05652-900
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 04502-001
    • Instituto D Or de Pesquisa e Ensino (IDOR)
• 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, 510060
    • Sun Yat-sen University Cancer Center
  • Guangzhou, China, 510120
    • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • 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
  • Xian, China, 710061
    • The First Affiliated Hospital of Xian Jiaotong University
• France
  • Angers, France, 49055
    • Institut de Cancerologie de l Ouest ICO
  • Besancon Cedex, France, 25030
    • Hôpital Jean Minjoz
  • Bordeaux, France, 33000
    • Institut Bergonie
  • Brest, France, 29609
    • CHRU Brest - Hôpital Morvan
  • Clermont Ferrand, France, 63011
    • Centre Jean Perrin
  • Dijon, France, 21079
    • Centre Georges-François Leclerc
  • Lille, France, 59020
    • Centre Oscar Lambret
  • Lille, France, 59000
    • Hôpital privé 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
    • Hopital Europeen Georges-Pompidou
  • Paris Cedex 10, France, 75475
    • Hôspital Saint-Louis
  • Pierre-Bénite, France, 69495
    • Hospices Civils de Lyon HCL
  • Poitiers Cedex, France, 86021
    • Chu de Poitiers
  • Rennes Cedex, France, 35062
    • Centre Eugene 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 Cedex, 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
  • Duesseldorf, Germany, 40225
    • Universitaetsklinikum Duesseldorf
  • Erlangen, Germany, 91054
    • Friedrich-Alexander Universitaet Urologische Universitaetskl
  • Frankfurt, Germany, 60590
    • Universitatsklinikum Frankfurt
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg
  • Greifswald, Germany, 17475
    • Universitätsmedizin Greifswald
  • Göttingen, Germany, 37099
    • Universitatsmedizin Gottingen
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Lubeck, Germany, 23538
    • Universitatsklinikum Schleswig Holstein Campus Lubeck
  • Mannheim, Germany, 68167
    • Medizinische Fakultat Mannheim der Universitat Heidelberg
  • Muenster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Nuertingen, 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.
  • Athina, Greece, 115 28
    • University of Athens Medical School - Regional General Hospi
  • Larisa, Greece, 41110
    • University Hospital of Larissa
  • Patras, Greece, 26504
    • University General Hospital of Rio Patras
  • Thessaloniki, Greece, 54645
    • Euromedica General Clinic
  • Thessaloniki, Greece, 14564
    • Interbalkan European Medical Center
  • Thessaloniki, Greece, 56403
    • 'Papageorgiou' General Hospital of Thessaloniki
• 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-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
  • 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 Hashomer, Israel, 52621
    • The Chaim Sheba Medical Center
  • Tel-Aviv, Israel, 64239
    • Sourasky 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
  • Firenze, Italy, 50139
    • Oncología Médica
  • Genova, Italy
    • SPDC Villa Scassi
  • Macerata, Italy, 62100
    • UOC Oncologia Ospedale Provinciale di Macerata
  • Meldola, Italy, 47014
    • IRST Meldola - Forlì
  • Milan, Italy, 20132
    • IRCCS Ospedale San Raffaele
  • Milano, Italy, 20141
    • European Institute of Oncology
  • Milano, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Modena, Italy, 41124
    • AOU Policlinico di Modena
  • Napoli, Italy, 80131
    • IRCCS-Fondazione Pascale
  • Novara, Italy, 28100
    • Ospedale Maggiore della Carità
  • 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
  • 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
    • National Hospital Organizaiton Shikoku Cancer Center
  • Miyazaki, Japan, 889-1692
    • University of Miyazaki Hospital
  • Nagano, Japan, 381-8551
    • Nagano Municipal Hospital
  • Nagoya-Shi, Japan, 464-8681
    • Aichi Cancer Center Hospital
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Osaka, Japan, 545 8586
    • Osaka City University Hospital
  • Osaka-Sayama, Japan, 589-8511
    • Kindai University Hospital
  • Ota, Japan, 373 8550
    • Gunma Prefectural Cancer Center
  • 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, 135-8550
    • The Cancer Institute Hospital of JFCR
  • Tokyo, Japan, 105-8470
    • Toranomon Hospital
  • Tsukuba, Japan, 305 8576
    • University of Tsukuba Hospital
  • Ube, Japan, 755-8505
    • Yamaguchi University Hospital
  • Yokohama, Japan, 232 0024
    • Yokohama City University Medical Center
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Goyangsi, Korea, Republic of, 410-769
    • National Cancer Center
  • Gwangju, Korea, Republic of, 61469
    • Chonnam National University Hospital
  • Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Wonju-si, Korea, Republic of, 26426
    • Yonsei University Wonju Severance Christian Hospital
• Mexico
  • Aguascalientes, Mexico, 20230
    • Medicos Especialistas en Cancer, S.C.
  • Chihuahua, Mexico, 31000
    • Centro Estatal de Cancerologia de Chihuahua
  • Naucalpan, Mexico, 53100
    • Oncologia Integral Satelite
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • NKI-AVL, Amsterdam
  • Den Haag, Netherlands, 2545 CH
    • Haga ziekenhuis
  • Nieuwegein, Netherlands, 3430 EM
    • St. Antonius Ziekenhuis Nieuwegein
• Poland
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Warszawa, Poland, 02-781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
  • Wroclaw, Poland, 50-556
    • Uniwersytecki Szpital Kliniczny we Wrocławiu
• Portugal
  • Lisboa, Portugal, G1R 2J6
    • Chlc - Hosp. Sto Antonio Dos Capuchos
  • Lisboa, Portugal, 1500-458
    • Hospital Lusíadas
  • Lisboa, Portugal, 1649-035
    • H. Santa Maria - Centro Hospitalar de Lisboa Norte
  • Lisbon, Portugal, 1400-038
    • Champalimaud Foundation Champalimaud Centre
  • Porto, Portugal, 4200072
    • Instituto Português de Oncologia
• Russian Federation
  • Barnaul, Russian Federation, 656049
    • Altai Regional Oncology Dispensary
  • Chelyabinsk, Russian Federation, 454087
    • Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
  • Irkutsk, Russian Federation, 664035
    • Irkutsk Regional Oncology Dispensary
  • Ivanovo, Russian Federation, 153040
    • Ivanovo Regional Oncology Dispensary
  • Kostroma, Russian Federation, 156005
    • Kostroma regional oncology dispensary
  • Kuzmolovsky, Russian Federation, 188663
    • Leningrad Regional Oncology Dispensary
  • Moscow, Russian Federation, 125284
    • Hertzen Oncology Research Institute
  • Moscow, Russian Federation, 119991
    • I.M. Sechenov First Moscow State Medical University
  • Moscow, Russian Federation, 117997
    • Russian Scientific Center of Roentgenoradiology
  • Moscow, Russian Federation, 105077
    • City Clinical Hospital n.a. D.D.Pletnev
  • Moscow, Russian Federation, 115478
    • FSBSI 'N. N. Blokhin Russian Cancer Research Center'
  • Nalchik, Russian Federation, 360017
    • City Clinical Hospital #1
  • Nizhni Novgorod, Russian Federation, 603109
    • Privolzhsky District Medical Center under the Federal Medico-Biological Agency
  • Omsk, Russian Federation, 644013
    • Clinical Oncology Dispensary
  • Pyatigorsk, Russian Federation, 357502
    • GBUZ of Stavropol region Pyatigorsk Oncological Dispensary
  • Saint Petersburg, Russian Federation, 197022
    • Pavlov First Saint Petersburg State Medical University
  • Saint Petersburg, Russian Federation, 196603
    • Private Medical Institution Euromedservice
  • Saint-Petersburg, Russian Federation, 192148
    • LLC 'Strategic Medical Systems'
  • Saint-Petersburg, Russian Federation, 195067
    • Clinical hopital n/a Petra velikogo
  • Saransk, Russian Federation, 430032
    • FGBOU Vo Mordovian National Research State University N. A. N.P. Ogareva
  • Saratov, Russian Federation, 410000
    • Saratov State Medical University
  • Smolensk, Russian Federation, 214031
    • LLC Uromed
  • Sochi, Russian Federation, 354057
    • GBUZ Oncology Centre #2 of Healthcare Department of Krasno
  • St. Petersburg, Russian Federation, 197758
    • Russian Scientific Center of Radiology and Surgical Technologies
  • St.Petersburg, Russian Federation, 197758
    • Saint-Petersburg Clinical Scientific And Practical Center For Special Types Of Medical Care
  • Tyumen, Russian Federation, 625041
    • Multifunctional clinical medical center 'Medical city'
  • Ufa, Russian Federation, 450000
    • Bashkiria State Medical University
  • Vologda, Russian Federation, 160012
    • Vologda Regional Oncological Dispensary
• 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
  • Sevilla, Spain, 41013
    • Hosp. Virgen Del Rocio
  • Sevilla, 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, 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, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei, Taiwan, 11259
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taipei City, Taiwan, 10002
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 333
    • Chang-Gung Memorial Hospital, LinKou Branch
• Turkey
  • Adana, Turkey, 01120
    • Baskent University Adana Practice and Research Center Kisla Health Campus
  • Ankara, Turkey, 6100
    • Hacettepe University Medical Faculty
  • Istanbul, Turkey, 34098
    • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul, Turkey, 34214
    • Medipol Mega University Hospital
  • Istanbul, Turkey, 34722
    • T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi
  • Istanbul, Turkey, 34147
    • Bakirkoy Training and Research Hospital
  • Istanbul, Turkey, 34093
    • Bezmialem University Medical Faculty
  • Istanbul, Turkey, 34890
    • Pendik Training and Research Hospital
  • Izmir, Turkey, 35100
    • Ege University
  • Izmir, Turkey, 35340
    • Dokuz Eylul Universitesi Tip Fakultesi
  • Kocaeli, Turkey
    • Kocaeli University Medical Faculty
  • Malatya, Turkey, 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'
  • Uzhgorod, 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
    • Saint Helena, California, United States, 94574
      • St. Helena Hospital - Martin-O'Neil Cancer Center
  • District of Columbia
    • Washington, 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
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • New York, New York, United States, 10029
      • Weill Cornell Medical College
  • 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 is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.	Date of first randomization to the date of participant's death (approximately up to 3 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST v1.1] by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.	Date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever is reported first (approximately up to 3 years)
Overall Response Rate (ORR)	ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.	Approximately up to 3 years
Change from Baseline in Participant-Reported Health Status and Physical Functioning Scales of the Functional Assessment of Cancer Therapy (FACT-Bl)	The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being, and bladder symptom subscale. The answer scales range from "Not at all (score=0)" to "very much (score=4)" to assess the meaningful significant symptom deterioration.	Baseline up to end of treatment (approximately 3 years)
Time Until Symptom Deterioration (Subset of FACT-BI Items)	The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being, and bladder symptom subscale. The answer scales range from "Not at all (score=0)" to "very much (score=4)" to assess the meaningful significant symptom deterioration.	Baseline up to end of treatment (approximately 3 years)
Change from Baseline in Patient-Global Impression of Severity (PGIS) Score	The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.	Baseline up to end of treatment (approximately 3 years)
Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L	European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.	Baseline up to follow up phase (approximately 3 years)
Change from Baseline in the Utility Scale of the EQ-5D-5L	The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead.	Baseline up to follow up phase (approximately 3 years)
Duration of Response (DOR)	DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.	From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)
Number of Participants with Adverse Events (AEs) as a Measure of Safety	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Approximately up to 3 years
Oral Clearance (CL/F) of Erdafitinib	CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.	Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)
Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib	AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.	Day 14 (Cycle 1), Day 1 (Cycle 2) (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

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2018
• Primary Completion (Estimated): September 11, 2024
• Study Completion (Estimated): September 11, 2024

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): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Docetaxel; Pembrolizumab; Mitogens
• Other Study ID Numbers: CR108401; 2017-002932-18 (EudraCT Number); 42756493BLC3001 (Other Identifier: Janssen Research & Development, LLC); 2023-509329-32-00 (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