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

Urothelial Cancer Clinical Trial

— THOR  

Official title:

A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03390504
• Other study ID #: CR108401
• Secondary ID: 2017-002932-1842
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 23, 2018
• Est. completion date: November 1, 2026

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-[L]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 629
• Est. completion date: November 1, 2026
• Est. primary completion date: September 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urothelial Cancer

Intervention

Drug:
• Erdafitinib
Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.
• Vinflunine
Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.
• Docetaxel
Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.
• Pembrolizumab
Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.

Device:
• Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
FGFRi CTA will be used to determine molecular eligibility.

Locations

Country	Name	City	State
Argentina	Centro Oncológico Korben	Buenos Aires
Argentina	Sociedade Beneficente de Senhoras - Hospital Sírio Libanês	Buenos Aires
Argentina	CEMIC Saavedra	Ciudad Autonoma de Buenos Aires
Argentina	Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica	Cordoba
Argentina	Centro Urologico Profesor Bengio	Cordoba
Argentina	Hospital Privado de Comunidad	Mar Del Plata
Argentina	Centro de Investigacion Pergamino SA	Pergamino
Argentina	Clínica Viedma	Viedma
Australia	Chris O'Brien Lifehouse	Camperdown
Australia	Peninsula & South Eastern Haematology and Oncology Group	Frankston
Australia	St George Hospital	Kogarah
Australia	Frankston Hospital	Melbourne
Australia	Peter MacCallum Cancer Centre	Melbourne
Australia	Fiona Stanley Hospital	Murdoch
Austria	LKH-Univ. Klinikum Graz	Graz
Austria	Ordensklinikum Linz GmbH Elisabethinen	Linz
Austria	LKH - Universitätsklinikum der PMU Salzburg	Salzburg
Austria	Krankenhaus der Barmherzigen Brüder	Vienna
Austria	Medical University Vienna MUV	Vienna
Belgium	OLV Ziekenhuis Aalst	Aalst
Belgium	ZNA Middelheim	Antwerpen
Belgium	Cliniques Universitaires Saint Luc	Bruxelles
Belgium	Clinique Notre Dame de Grâce	Charleroi
Belgium	AZ Maria Middelares	Gent
Belgium	UZ Gent	Gent
Belgium	CHC MontLegia	Liege
Belgium	Sint-Augustinus AZ	Wilrijk
Belgium	CHU UCL Namur - Site Godinne	Yvoir
Brazil	Fundacao Pio XII	Barretos
Brazil	Nucleo de Ensino e Pesquisa do Instituto Mario Penna	Belo Horizonte
Brazil	Universidade Federal De Minas Gerais - Hospital das Clínicas	Belo Horizonte
Brazil	Instituto de Oncologia do Parana	Curitiba
Brazil	Liga Paranaense de Combate ao Cancer	Curitiba
Brazil	Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge	Goiania
Brazil	Clínica de Neoplasias Litoral Ltda.	Itajai
Brazil	Fundacao Doutor Amaral Carvalho	Jau
Brazil	Liga Norte Riograndense Contra O Cancer	Natal
Brazil	Hospital das Clinicas de Porto Alegre	Porto Alegre
Brazil	Hospital Nossa Senhora da Conceicao S A	Porto Alegre
Brazil	Ministerio da Saude - Instituto Nacional do Cancer	Rio De Janeiro
Brazil	Oncoclinicas Rio de Janeiro S A	Rio de Janeiro
Brazil	Hospital Sao Rafael	Salvador
Brazil	CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia	Santo Andre
Brazil	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base	Sao Jose do Rio Preto
Brazil	Fundacao Antonio Prudente A C Camargo Cancer Center	Sao Paulo
Brazil	Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia	Sao Paulo
Brazil	Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein	Sao Paulo
Brazil	Instituto D Or de Pesquisa e Ensino (IDOR)	São Paulo
Brazil	Sociedade Beneficente de Senhoras - Hospital Sírio Libanês	São Paulo
Brazil	Instituto de Oncologia de Sorocaba Onco Clinicas Especializadas	Sorocaba
Bulgaria	UMHAT 'Dr. Georgi Stranski', EAD	Pleven
Bulgaria	Complex Oncology Center - Plovdiv EOOD	Plovdiv
Bulgaria	Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'	Sofia
Bulgaria	UMHAT Sofia Med	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD	Varna
Canada	BC Cancer Agency - Southern Interior	Kelowna	British Columbia
Canada	Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Princess Margaret Hospital- UHN	Toronto	Ontario
Canada	Vancouver Cancer Centre	Vancouver	British Columbia
Canada	Cancercare Manitoba	Winnipeg	Manitoba
China	Beijing Friendship Hospital	Beijing
China	Beijing Hospital	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Peking University First Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	The First Bethune Hospital of Jilin University	Changchun
China	Sichuan Provincial Peoples Hospital	Chengdu
China	Sichuan University Huaxi Hospital	Chengdu
China	Chongqing University Cancer Hospital	ChongQing
China	Guangzhou First Municipal People's Hospital	Guangzhou
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou
China	Sun Yat-Sen University Cancer Center	Guangzhou
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Provincial People's Hospital	Hangzhou
China	The First Affliated Hospital Of Nanchang University	Nanchang
China	Jiangsu Cancer Hospital	Nanjing
China	Nanjing Drum Tower Hospital	Nanjing
China	Huadong Hospital Affiliated to Fudan University	Shanghai
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	ShangHai
China	Shengjing Hospital Of China Medical University	Shenyang
China	Shenzhen university General Hospital	Shenzhen
China	First Affiliated Hospital Of Wenzhou Medical College	Wenzhou
China	The First Affiliated Hospital of Xian Jiaotong University	Xian
France	Institut de Cancerologie de l Ouest ICO	Angers
France	Hopital Jean Minjoz	Besancon Cedex
France	Institut Bergonie	Bordeaux
France	CHRU Brest - Hopital Morvan	Brest
France	Centre Jean Perrin	Clermont Ferrand
France	Centre Georges-François Leclerc	Dijon
France	Centre Oscar Lambret	Lille
France	Hôpital Privé Le Bois	Lille
France	Groupe Hospitalier Bretagne Sud	Lorient
France	Hopital de la Timone	Marseille
France	Institut Regional du Cancer de Montpellier Val d'Aurelle	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Institut de Cancérologie du Gard	Nîmes
France	Hopital Europeen Georges-Pompidou	Paris
France	Hospital Saint-Louis	Paris Cedex 10
France	Hospices Civils de Lyon HCL	Pierre-Bénite
France	CHU De Poitiers	Poitiers Cedex
France	Centre Eugene Marquis	Rennes Cedex
France	Centre de radiothérapie et d'Oncologie médicale de l'Essonne	Ris Orangis
France	Institut de Cancérologie de Loire	Saint-Priest-en-Jarez
France	Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre	Strasbourg Cedex
France	Institut Claudius Regaud	Toulouse
France	Centre Les Dentellieres	Valenciennes
France	Institut Gustave Roussy	Villejuif
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie	Braunschweig
Germany	Universitatsklinikum Carl Gustav Carcus Dresden	Dresden
Germany	Universitaetsklinikum Duesseldorf	Duesseldorf
Germany	Friedrich-Alexander Universitaet Urologische Universitaetskl	Erlangen
Germany	Universitatsklinikum Frankfurt	Frankfurt
Germany	Universitatsklinikum Freiburg	Freiburg
Germany	Universitatsmedizin Gottingen	Göttingen
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	Asklepios Klinik Altona	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitatsklinikum Schleswig Holstein Campus Lubeck	Lubeck
Germany	Medizinische Fakultät Mannheim der Universität Heidelberg	Mannheim
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Studienpraxis Urologie Drs. Feyerabend	Nuertingen
Germany	Caritas-Krankenhaus St. Josef	Regensburg
Germany	Universitaetsmedizin Rostock	Rostock
Germany	MVZ-Onkologie Velbert GbR	Velbert
Germany	Kliniken Nordoberpfalz AG/Klinikum Weiden	Weiden
Greece	Athens Medical Center	Athens
Greece	Errikos Dunant Hospital Center	Athens
Greece	Metropolitan General A E	Athens
Greece	University of Athens Medical School - Regional General Hospi	Athina
Greece	University Hospital Of Larissa	Larisa
Greece	University General Hospital of Rio Patras	Patras
Greece	Euromedica General Clinic	Thessaloniki
Greece	Interbalkan European Medical Center	Thessaloniki
Greece	Papageorgiou General Hospital Of Thessaloniki	Thessaloniki
Hungary	Budapesti Uzsoki Utcai Korhaz	Budapest
Hungary	Országos Onkológiai Intézet, Urogenitális Tumorok és Klinikai Farmakológiai Osztály	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz	Nyíregyháza
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pécs
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center, Beilinson Hospital	Petach Tikvah
Israel	The Chaim Sheba Medical Center	Tel Hashomer
Israel	Sourasky Medical Center	Tel-Aviv
Israel	Assaf Harofeh Medical Center	Tzrifin
Italy	Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria	Alessandria
Italy	Ospedale S. Donato - Asl 8 Arezzo	Arezzo
Italy	CRO IRCCS Istituto Nazionale Tumori	Aviano
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo
Italy	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili	Brescia
Italy	Istituti Ospitalieri di Cremona, AO di Cremona	Cremona
Italy	Oncologia Medica	Firenze
Italy	SPDC Villa Scassi	Genova
Italy	UOC Oncologia Ospedale Provinciale di Macerata	Macerata
Italy	IRST Meldola Forli	Meldola
Italy	IRCCS Ospedale San Raffaele	Milan
Italy	European Institute of Oncology	Milano
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano
Italy	AOU Policlinico di Modena	Modena
Italy	IRCCS-Fondazione Pascale	Napoli
Italy	Ospedale Maggiore della Carita	Novara
Italy	Aou San Luigi Gonzaga	Orbassano
Italy	Istituto Oncologico Veneto Iov Irccs Padova	Padova
Italy	AOU di Parma	Parma
Italy	IRCCS Policlinico San Matteo	Pavia
Italy	Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncolo	Pavia
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST	Poggibonsi (SI)
Italy	Fondazione Policlinico Universitario A Gemelli IRCCS	Roma
Italy	Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte	Siena
Italy	Oncologia Medica-Città Della Salute E Della Scienza Di Torino	Torino
Italy	Azienda Ospedaliero - Universitaria Ospedali Riuniti	Torrette Di Ancona
Japan	Chiba Cancer Center	Chiba
Japan	Hirosaki University Hospital	Hirosaki
Japan	National Cancer Center Hospital East	Kashiwa
Japan	Kagawa University Hospital	Kita-Gun
Japan	Kobe City Medical Center General Hospital	Kobe
Japan	Dokkyo Medical University Saitama Medical Center	Koshigaya
Japan	National Hospital Organizaiton Shikoku Cancer Center	Matsuyama
Japan	University of Miyazaki Hospital	Miyazaki
Japan	Nagano Municipal Hospital	Nagano
Japan	Aichi Cancer Center Hospital	Nagoya Shi
Japan	Osaka City University Hospital	Osaka
Japan	Osaka International Cancer Institute	Osaka City
Japan	Kindai University Hospital	Osaka-Sayama
Japan	Gunma Prefectural Cancer Center	Ota
Japan	Kitasato University Hospital	Sagamihara
Japan	Toho University Sakura Medical Center	Sakura
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo
Japan	Tokyo Women's Medical University Hospital	Shinjuku-ku
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Japan	Toranomon Hospital	Tokyo
Japan	University of Tsukuba Hospital	Tsukuba
Japan	Yamaguchi University Hospital	Ube
Japan	Yokohama City University Medical Center	Yokohama
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	National Cancer Center	Goyangsi
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju-si
Mexico	Medicos Especialistas en Cancer, S.C.	Aguascalientes
Mexico	Centro Estatal de Cancerología de Chihuahua	Chihuahua
Mexico	Oncologia Integral Satelite	Naucalpan
Netherlands	NKI AVL Amsterdam	Amsterdam
Netherlands	Haga ziekenhuis	Den Haag
Netherlands	St. Antonius Ziekenhuis Nieuwegein	Nieuwegein
Poland	Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy	Bydgoszcz
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie	Warszawa
Poland	Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy	Warszawa
Poland	Uniwersytecki Szpital Kliniczny we Wroclawiu	Wroclaw
Portugal	Chlc - Hosp. Sto Antonio Dos Capuchos	Lisboa
Portugal	H. Santa Maria - Centro Hospitalar de Lisboa Norte	Lisboa
Portugal	Hospital Lusíadas	Lisboa
Portugal	Champalimaud Foundation Champalimaud Centre	Lisbon
Portugal	Instituto Portugues de Oncologia	Porto
Russian Federation	Altai Regional Oncology Dispensary	Barnaul
Russian Federation	Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine	Chelyabinsk
Russian Federation	Irkutsk Regional Oncology Dispensary	Irkutsk
Russian Federation	Ivanovo Regional Oncology Dispensary	Ivanovo
Russian Federation	Kostroma regional oncology dispensary	Kostroma
Russian Federation	Leningrad Regional Oncology Dispensary	Kuzmolovsky
Russian Federation	City Clinical Hospital n.a. D.D.Pletnev	Moscow
Russian Federation	FSBSI 'N. N. Blokhin Russian Cancer Research Center'	Moscow
Russian Federation	Hertzen Oncology Research Institute	Moscow
Russian Federation	I.M. Sechenov First Moscow State Medical University	Moscow
Russian Federation	Russian Scientific Center of Roentgenoradiology	Moscow
Russian Federation	City Clinical Hospital #1	Nalchik
Russian Federation	Privolzhsky District Medical Center under the Federal Medico-Biological Agency	Nizhni Novgorod
Russian Federation	Clinical Oncology Dispensary	Omsk
Russian Federation	GBUZ of Stavropol region Pyatigorsk Oncological Dispensary	Pyatigorsk
Russian Federation	Pavlov First Saint Petersburg State Medical University	Saint Petersburg
Russian Federation	Private Medical Institution Euromedservice	Saint Petersburg
Russian Federation	Clinical hopital n/a Petra velikogo	Saint-Petersburg
Russian Federation	LLC 'Strategic Medical Systems'	Saint-Petersburg
Russian Federation	FGBOU Vo Mordovian National Research State University N. A. N.P. Ogareva	Saransk
Russian Federation	Saratov State Medical University	Saratov
Russian Federation	LLC Uromed	Smolensk
Russian Federation	GBUZ Oncology Centre #2 of Healthcare Department of Krasno	Sochi
Russian Federation	Russian Scientific Center of Radiology and Surgical Technologies	St. Petersburg
Russian Federation	Saint-Petersburg Clinical Scientific And Practical Center For Special Types Of Medical Care	St.Petersburg
Russian Federation	Multifunctional clinical medical center 'Medical city'	Tyumen
Russian Federation	Bashkiria State Medical University	Ufa
Russian Federation	Vologda Regional Oncological Dispensary	Vologda
Spain	Hosp. Univ. Infanta Cristina	Badajoz
Spain	Institut Català D'Oncologia-Hospital Universitari Germans Trias I Pujol	Badalona
Spain	Hosp Clinic de Barcelona	Barcelona
Spain	Hosp. de La Santa Creu I Sant Pau	Barcelona
Spain	Hosp. San Pedro de Alcantara	Cáceres
Spain	Hosp Reina Sofia	Córdoba
Spain	Hosp. Univ. Virgen de Las Nieves	Granada
Spain	Complejo Hospitalario de Jaen	Jaén
Spain	Hosp. Univ. Insular de Gran Canaria	Las Palmas de Gran Canaria
Spain	Hosp. Univ. Lucus Augusti	Lugo
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Univ. La Paz	Madrid
Spain	Hosp. Univ. Pta. de Hierro Majadahonda	Majadahonda
Spain	ALTHAIA, Xarxa Assistencial Universitària de Manresa	Manresa
Spain	Hosp. de Navarra	Pamplona
Spain	Hosp. Virgen Del Rocio	Sevilla
Spain	Hosp. Virgen Macarena	Sevilla
Spain	Hosp. Gral. Univ. Valencia	Valencia
Spain	Hosp. Univ. I Politecni La Fe	Valencia
Spain	Hosp. Univ. Miguel Servet	Zaragoza
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Chang Gung Medical Foundation	Niao-Sung Hsiang
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chi Mei Medical Center Yong Kang	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Chang-Gung Memorial Hospital, LinKou Branch	Taoyuan
Turkey	Baskent University Adana Practice and Research Center Kisla Health Campus	Adana
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	Bakirkoy Training and Research Hospital	Istanbul
Turkey	Bezmialem University Medical Faculty	Istanbul
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul
Turkey	Medipol Mega University Hospital	Istanbul
Turkey	Pendik Training and Research Hospital	Istanbul
Turkey	T C Saglik Bakanligi Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi	Istanbul
Turkey	Dokuz Eylul Universitesi Tip Fakultesi	Izmir
Turkey	Ege University	Izmir
Turkey	Kocaeli University Medical Faculty	Kocaeli
Turkey	Inonu Universitesi Turgut Ozal Tip Merkezi, Ic Hastaliklari	Malatya
Ukraine	Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4	Dnipro
Ukraine	Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council	Dnipro
Ukraine	MI Dnipropetrovsk Region Clinical Hospital n a I.I.Mechnikov	Dnipropetrovsk
Ukraine	Ivano-Frankivsk Regional Clinical Hospital	Ivano-Frankivsk
Ukraine	Municipal non-profit enterprise 'Regional Center of Oncology'	Kharkiv
Ukraine	Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval	Kharkiv
Ukraine	National Cancer Institute	Kyiv
Ukraine	State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center	Kyiv
Ukraine	Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'	Lviv
Ukraine	Transkarpathian Regional University Oncology Clinic	Uzhgorod
Ukraine	Podilskiy Regional Center of Oncology	Vinnitsa
Ukraine	Zaokod	Zaporizhzhia
Ukraine	Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital	Zaporizhzhia
United Kingdom	University Hospitals Bristol - Bristol Haematology & Oncolog	Bristol
United Kingdom	Charing Cross Hospital	London
United Kingdom	Sarah Cannon Research Institute	London
United Kingdom	St Bartholomew's Hospital	London
United Kingdom	The Christie NHS Foundation Trust Christie Hospital	Manchester
United Kingdom	Derriford Hospital-Department of Medical Oncology	Plymouth
United Kingdom	University of Sheffield	Sheffield
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	Royal Marsden Hospital	Sutton
United States	Alaska Urological Institute dba Alaska Clinical Research Center	Anchorage	Alaska
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Piedmont Cancer Institute	Atlanta	Georgia
United States	Montefiore Medical Center	Bronx	New York
United States	Levine Cancer Institute, Carolinas HealthCare System	Charlotte	North Carolina
United States	Rush University	Chicago	Illinois
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	INOVA Dwiight &Martha Schar Cancer Institute	Fairfax	Virginia
United States	The Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	Edward Hines Jr V A Hospital	Hines	Illinois
United States	MD Anderson Cancer Center	Houston	Texas
United States	Texas Oncology-Memorial City	Houston	Texas
United States	Maryland Oncology Hematology, PA	Lanham	Maryland
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Norton Cancer Institute	Louisville	Kentucky
United States	University of Miami Sylvester Cancer Center	Miami	Florida
United States	Weill Cornell Medical College	New York	New York
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Mid Florida Hematology Oncology	Orange	Florida
United States	VA Sierra Nevada Health Care System	Reno	Nevada
United States	University of Calif Davis Medical Center	Sacramento	California
United States	St. Helena Hospital - Martin-O'Neil Cancer Center	Saint Helena	California
United States	W. G. 'Bill' Hefner VA Medical Center	Salisbury	North Carolina
United States	VA Puget Sound Healthcare System	Seattle	Washington
United States	Texas Oncology Tyler	Tyler	Texas
United States	MedStar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Russian Federation,  Spain,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)