AzTrials
AzTrials

Urothelial CancerPhase 3THORNCT03390504

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

A Phase 3 study testing Erdafitinib, Vinflunine and Docetaxel in people with Urothelial Cancer, run by Janssen Research & Development, LLC at 345 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Cancer
What is being tested?
Erdafitinib, Vinflunine and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
629 participants
Where
345 sitesin 27 countries
Study dates
23 Mar 2018to 31 Dec 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

345 sites in 27 countries.

345 sites in 27 countries

Russia28 sites

  • Altai Regional Oncology Dispensary

    Barnaul, 656049

  • Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

    Chelyabinsk, 454087

  • Irkutsk Regional Oncology Dispensary

    Irkutsk, 664035

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • Kostroma regional oncology dispensary

    Kostroma, 156005

  • Leningrad Regional Oncology Dispensary

    Kuzmolovsky, 188663

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

    Moscow, 105077

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

    Moscow, 115478

  • Russian Scientific Center of Roentgenoradiology

    Moscow, 117997

  • I.M. Sechenov First Moscow State Medical University

    Moscow, 119991

  • Hertzen Oncology Research Institute

    Moscow, 125284

  • City Clinical Hospital #1

    Nal'chik, 360017

  • Privolzhsky District Medical Center under the Federal Medico-Biological Agency

    Nizhny Novgorod, 603109

  • Clinical Oncology Dispensary

    Omsk, 644013

  • GBUZ of Stavropol region Pyatigorsk Oncological Dispensary

    Pyatigorsk, 357502

  • LLC 'Strategic Medical Systems'

    Saint Petersburg, 192148

  • Clinical hopital n/a Petra velikogo

    Saint Petersburg, 195067

  • Private Medical Institution Euromedservice

    Saint Petersburg, 196603

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197022

  • Russian Scientific Center of Radiology and Surgical Technologies

    Saint Petersburg, 197758

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

    Saint Petersburg, 197758

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

    Saransk, 430032

  • Saratov State Medical University

    Saratov, 410000

  • LLC Uromed

    Smolensk, 214031

  • GBUZ Oncology Centre #2 of Healthcare Department of Krasno

    Sochi, 354057

  • Multifunctional clinical medical center 'Medical city'

    Tyumen, 625041

  • Bashkiria State Medical University

    Ufa, 450000

  • Vologda Regional Oncological Dispensary

    Vologda, 160012

Other trials in Russia

Italy27 sites

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

    Alessandria, 15121

  • Ospedale S. Donato - Asl 8 Arezzo

    Arezzo, 52100

  • CRO IRCCS Istituto Nazionale Tumori

    Aviano, 33081

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

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

    Brescia, 25123

  • Istituti Ospitalieri di Cremona, AO di Cremona

    Cremona, 26100

  • Oncologia Medica

    Florence, 50139

  • SPDC Villa Scassi

    Genova

  • IRST Meldola Forli

    Meldola, 47014

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • European Institute of Oncology

    Milan, 20141

  • AOU Policlinico di Modena

    Modena, 41124

  • IRCCS-Fondazione Pascale

    Naples, 80131

  • Ospedale Maggiore della Carita

    Novara, 28100

  • Aou San Luigi Gonzaga

    Orbassano, 10043

  • Istituto Oncologico Veneto Iov Irccs Padova

    Padova, 35128

  • AOU di Parma

    Parma, 43126

  • IRCCS Policlinico San Matteo

    Pavia, 27100

  • Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncolo

    Pavia, 27100

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

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

    Poggibonsi (SI), 53100

  • UOC Oncologia Ospedale Provinciale di Macerata

    Province of Macerata, 62100

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

  • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte

    Siena, 53100

  • Oncologia Medica-Città Della Salute E Della Scienza Di Torino

    Torino, 10123

  • Azienda Ospedaliero - Universitaria Ospedali Riuniti

    Torrette Di Ancona, 60126

Other trials in Italy

United States26 sites

  • Alaska Urological Institute dba Alaska Clinical Research Center

    Anchorage, Alaska, 99503

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-5000

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30318-0922

  • Levine Cancer Institute, Carolinas HealthCare System

    Charlotte, North Carolina, 28204

  • Rush University

    Chicago, Illinois, 60612

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • INOVA Dwiight &Martha Schar Cancer Institute

    Fairfax, Virginia, 22031

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Edward Hines Jr V A Hospital

    Hines, Illinois, 60141

  • Texas Oncology-Memorial City

    Houston, Texas, 77024

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Maryland Oncology Hematology, PA

    Lanham, Maryland, 20706

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • University of Miami Sylvester Cancer Center

    Miami, Florida, 33136

  • Weill Cornell Medical College

    New York, New York, 10029

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Mid Florida Hematology Oncology

    Orange, Florida, 32763

  • VA Sierra Nevada Health Care System

    Reno, Nevada, 89509

  • University of Calif Davis Medical Center

    Sacramento, California, 95817

  • W G Bill Hefner VA Medical Center

    Salisbury, North Carolina, 28144

  • VA Puget Sound Healthcare System

    Seattle, Washington, 98108

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

    St. Helena, California, 94574

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Texas Oncology Tyler

    Tyler, Texas, 75702

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

China24 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Friendship Hospital

    Beijing, 100050

  • Peking University Third Hospital

    Beijing, 100191

  • Beijing Hospital

    Beijing, 100730

  • Peking Union Medical College Hospital

    Beijing, 100730

  • The First Bethune Hospital of Jilin University

    Changchun, 130021

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610000

  • Sichuan University Huaxi Hospital

    Chengdu, 610041

  • Chongqing University Cancer Hospital

    Chongqing, 400030

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510060

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

    Guangzhou, 510120

  • Guangzhou First Municipal People's Hospital

    Guangzhou, 510180

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310014

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310020

  • The First Affliated Hospital Of Nanchang University

    Nanchang, 330006

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200127

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, 200400

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004

  • Shenzhen university General Hospital

    Shenzhen, 518055

  • First Affiliated Hospital Of Wenzhou Medical College

    Wenzhou, 325000

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061

Other trials in China

France24 sites

  • Institut de Cancerologie de l Ouest ICO

    Angers, 49055

  • Hopital Jean Minjoz

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33000

  • CHRU Brest - Hopital Morvan

    Brest, 29609

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Georges-François Leclerc

    Dijon, 21079

  • Centre Oscar Lambret

    Lille, 59000

  • Hôpital Privé Le Bois

    Lille, 59000

  • Groupe Hospitalier Bretagne Sud

    Lorient, 56322

  • Hopital de la Timone

    Marseille, 13005

  • Institut Regional du Cancer de Montpellier Val d'Aurelle

    Montpellier, 34298

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut de Cancérologie du Gard

    Nîmes, 30029

  • Hopital Europeen Georges-Pompidou

    Paris, 75015

  • Hospital Saint-Louis

    Paris, 75475

  • Hospices Civils de Lyon HCL

    Pierre-Bénite, 69495

  • CHU De Poitiers

    Poitiers, 86021

  • Centre Eugene Marquis

    Rennes, 35062

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

    Ris-Orangis, 91130

  • Institut de Cancérologie de Loire

    Saint-Priest-en-Jarez, 42271

  • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67098

  • Institut Claudius Regaud

    Toulouse, 31059

  • Centre Les Dentellieres

    Valenciennes, 59300

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Japan23 sites

  • Chiba Cancer Center

    Chiba, 260-8717

  • Hirosaki University Hospital

    Hirosaki, 036-8563

  • National Cancer Center Hospital East

    Kashiwa, 277 8577

  • Kagawa University Hospital

    Kita Gun, 761 0793

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, 343-8555

  • Aso Co.,Ltd Iizuka Hospital

    Matsuyama, 791-0280

  • University of Miyazaki Hospital

    Miyazaki, 889-1692

  • Nagano Municipal Hospital

    Nagano, 381-8551

  • Aichi Cancer Center Hospital

    Nagoya, 464 8681

  • Osaka International Cancer Institute

    Osaka, 541 8567

  • Osaka City University Hospital

    Osaka, 545 8586

  • Kindai University Hospital

    Ōsaka-sayama, 589-8511

  • Gunma Prefectural Cancer Center

    Ōta-ku, 373-8550

  • Kitasato University Hospital

    Sagamihara, 252-0375

  • Toho University Sakura Medical Center

    Sakura, 285-8741

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, 003-0804

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, 162-8666

  • Toranomon Hospital

    Tokyo, 105-8470

  • The Cancer Institute Hospital of JFCR 1

    Tokyo, 135 8550

  • University of Tsukuba Hospital

    Tsukuba, 305 8576

  • Yamaguchi University Hospital

    Ube, 755-8505

  • Yokohama City University Medical Center

    Yokohama, 232 0024

Other trials in Japan

Brazil22 sites

  • Fundacao Pio XII

    Barretos, 14784-400

  • Universidade Federal De Minas Gerais - Hospital das Clínicas

    Belo Horizonte, 30130-100

  • Nucleo de Ensino e Pesquisa do Instituto Mario Penna

    Belo Horizonte, 30380-472

  • Instituto de Oncologia do Parana

    Curitiba, 80530-010

  • Liga Paranaense de Combate ao Cancer

    Curitiba, 81520 060

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

    Goiânia, 74605-070

  • Clínica de Neoplasias Litoral Ltda.

    Itajaí, 88301-220

  • Fundacao Doutor Amaral Carvalho

    Jaú, 17210 080

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59075-740

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Hospital Nossa Senhora da Conceicao S A

    Porto Alegre, 91350 200

  • Ministerio da Saude Instituto Nacional do Cancer

    Rio de Janeiro, 20231 050

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250 905

  • Hospital Sao Rafael

    Salvador, 41253-190

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060-650

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

    São José do Rio Preto, 15090-000

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes 1

    São Paulo, 01308 050

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

  • Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia

    São Paulo, 03102-002

  • Instituto D Or de Pesquisa e Ensino IDOR

    São Paulo, 04502-001

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652 900

  • Instituto de Oncologia de Sorocaba Onco Clinicas Especializadas

    Sorocaba, 18030-005

Other trials in Brazil

Spain20 sites

  • Hosp. Univ. Infanta Cristina

    Badajoz, 06006

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

    Badalona, 08916

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08041

  • Hosp. San Pedro de Alcantara

    Cáceres, 10003

  • Hosp Reina Sofia

    Córdoba, 14004

  • Hosp. Univ. Virgen de Las Nieves

    Granada, 18014

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Hosp. Univ. Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35016

  • Hosp. Univ. Lucus Augusti

    Lugo, 27003

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Majadahonda, 28220

  • ALTHAIA, Xarxa Assistencial Universitària de Manresa

    Manresa, 08243

  • Hosp. de Navarra

    Pamplona, 31008

  • Hosp. Virgen Macarena

    Seville, 41009

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Gral. Univ. Valencia

    Valencia, 46014

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

  • Hosp. Univ. Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Germany19 sites

  • Vivantes Klinikum Am Urban

    Berlin, 10967

  • Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie

    Braunschweig, 38126

  • Universitatsklinikum Carl Gustav Carcus Dresden

    Dresden, 01307

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

  • Friedrich-Alexander Universitaet Urologische Universitaetskl

    Erlangen, 91054

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitatsmedizin Gottingen

    Göttingen, 37099

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitatsklinikum Schleswig Holstein Campus Lubeck

    Lübeck, 23538

  • Medizinische Fakultät Mannheim der Universität Heidelberg

    Mannheim, 68167

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Studienpraxis Urologie Drs. Feyerabend

    Nürtingen, 72622

  • Caritas-Krankenhaus St. Josef

    Regensburg, 93053

  • Universitaetsmedizin Rostock

    Rostock, 18057

  • MVZ-Onkologie Velbert GbR

    Velbert, 42551

  • Kliniken Nordoberpfalz AG/Klinikum Weiden

    Weiden, 92637

Other trials in Germany

Ukraine13 sites

  • Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

    Dnipro, 49100

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

    Dnipro, 49102

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

    Dnipropetrovsk, 49005

  • Ivano-Frankivsk Regional Clinical Hospital

    Ivano-Frankivsk, 76008

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

    Kharkiv, 61037

  • Municipal non-profit enterprise 'Regional Center of Oncology'

    Kharkiv, 61070

  • National Cancer Institute

    Kyiv, 03022

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

    Kyiv, 03115

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

    Lviv, 79010

  • Transkarpathian Regional University Oncology Clinic

    Uzhhorod, 88000

  • Podilskiy Regional Center of Oncology

    Vinnitsa, 21029

  • Zaokod

    Zaporizhzhya, 69040

  • Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital

    Zaporizhzhya, 69600

Other trials in Ukraine

South Korea12 sites

  • Pusan National University Hospital

    Busan, 49241

  • Chungnam National University Hospital

    Daejeon, 35015

  • National Cancer Center

    Goyang-si, 410-769

  • Chonnam National University Hospital

    Gwangju, 61469

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 135-710

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 26426

Other trials in South Korea

Turkey (Türkiye)12 sites

  • Baskent University Adana Practice and Research Center Kisla Health Campus

    Adana, 01120

  • Hacettepe University Medical Faculty

    Ankara, 6100

  • Bezmialem University Medical Faculty

    Istanbul, 34093

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Bakirkoy Training and Research Hospital

    Istanbul, 34147

  • Medipol Mega University Hospital

    Istanbul, 34214

  • T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi

    Istanbul, 34722

  • Pendik Training and Research Hospital

    Istanbul, 34890

  • Ege University

    Izmir, 35100

  • Dokuz Eylul Universitesi Tip Fakultesi

    Izmir, 35340

  • Kocaeli University Medical Faculty

    Kocaeli

  • Inonu Universitesi Turgut Ozal Tip Merkezi, Ic Hastaliklari

    Malatya, 44400

Other trials in Turkey (Türkiye)

Taiwan11 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807

  • Chang Gung Medical Foundation

    Niao-Sung Hsiang, 833

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 70403

  • Chi Mei Medical Center Yong Kang

    Tainan, 710

  • National Taiwan University Hospital

    Taipei, 10002

  • Mackay Memorial Hospital

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 11259

  • Chang-Gung Memorial Hospital, LinKou Branch

    Taoyuan, 333

Other trials in Taiwan

Belgium9 sites

  • OLV Ziekenhuis Aalst

    Aalst, 9300

  • ZNA Middelheim

    Antwerp, 2020

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Clinique Notre Dame de Grâce

    Charleroi, 6000

  • AZ Maria Middelares

    Ghent, 9000

  • UZ Gent

    Ghent, 9000

  • CHC MontLegia

    Liège, 4000

  • Sint-Augustinus AZ

    Wilrijk, 2610

  • CHU UCL Namur - Site Godinne

    Yvoir, 5530

Other trials in Belgium

Greece9 sites

  • University of Athens Medical School - Regional General Hospi

    Athens, 115 28

  • Errikos Dunant Hospital Center

    Athens, 11526

  • Athens Medical Center

    Athens, 15125

  • Metropolitan General A E

    Athens, 15562

  • University Hospital Of Larissa

    Larissa, 41110

  • University General Hospital of Rio Patras

    Pátrai, 26504

  • Interbalkan European Medical Center

    Thessaloniki, 14564

  • Euromedica General Clinic

    Thessaloniki, 54645

  • Papageorgiou General Hospital Of Thessaloniki

    Thessaloniki, 56403

Other trials in Greece

United Kingdom9 sites

  • University Hospitals Bristol - Bristol Haematology & Oncolog

    Bristol, BS2 8ED

  • St Bartholomew's Hospital

    London, EC1A 7BE

  • Sarah Cannon Research Institute

    London, W1G 6AD

  • Charing Cross Hospital

    London, W6 8RF

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX

  • Derriford Hospital-Department of Medical Oncology

    Plymouth, PL6 8QH

  • University of Sheffield

    Sheffield, S10 2 RX

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Royal Marsden Hospital

    Sutton, SM2 5NG

Other trials in United Kingdom

Argentina8 sites

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    Buenos Aires, C1419AHN

  • Centro Oncológico Korben

    Buenos Aires, C1426AGE

  • CEMIC Saavedra

    Buenos Aires, C1431FWN

  • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, C5000

  • Centro Urologico Profesor Bengio

    Córdoba, X5000KPH

  • Hospital Privado de Comunidad

    Mar del Plata, B7602CBM

  • Centro de Investigacion Pergamino SA

    Pergamino, B2700CPM

  • Clínica Viedma

    Viedma, R8500ACE

Other trials in Argentina

Israel7 sites

  • Rambam Health Care Campus

    Haifa, 31096

  • Hadassah Medical Center

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center, Beilinson Hospital

    Petach Tikvah, 49100

  • Sourasky Medical Center

    Tel Aviv, 64239

  • The Chaim Sheba Medical Center

    Tel HaShomer, 52621

  • Assaf Harofeh Medical Center

    Tzrifin, 70300

Other trials in Israel

Australia6 sites

  • Chris O'Brien Lifehouse

    Camperdown, 2050

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, 3199

  • St George Hospital

    Kogarah, 2217

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

  • Frankston Hospital

    Melbourne, 3199

  • Fiona Stanley Hospital

    Murdoch, 6150

Other trials in Australia

Canada6 sites

  • BC Cancer Agency - Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 6V4

  • Princess Margaret Hospital- UHN

    Toronto, Ontario, M5G 2M9

  • Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • Cancercare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Austria5 sites

  • LKH-Univ. Klinikum Graz

    Graz, 8036

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, 4020

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

  • Krankenhaus der Barmherzigen Brüder

    Vienna, 1020

  • Medical University Vienna MUV

    Vienna, A-1090

Other trials in Austria

Bulgaria5 sites

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800

  • Complex Oncology Center - Plovdiv EOOD

    Plovdiv, 4004

  • Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

    Sofia, 1407

  • UMHAT Sofia Med

    Sofia, 1797

  • Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD

    Varna, 9010

Other trials in Bulgaria

Hungary5 sites

  • Semmelweis Egyetem

    Budapest, 1082

  • Országos Onkológiai Intézet, Urogenitális Tumorok és Klinikai Farmakológiai Osztály

    Budapest, 1122

  • Budapesti Uzsoki Utcai Korhaz

    Budapest, H-1145

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 04400

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7624

Other trials in Hungary

Portugal5 sites

  • Champalimaud Foundation Champalimaud Centre

    Lisbon, 1400-038

  • Hospital Lusíadas

    Lisbon, 1500-458

  • H. Santa Maria - Centro Hospitalar de Lisboa Norte

    Lisbon, 1649-035

  • Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos

    Lisbon, G1R 2J6

  • Instituto Portugues de Oncologia

    Porto, 4200072

Other trials in Portugal

Poland4 sites

  • Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85 796

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, 02-507

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

  • Uniwersytecki Szpital Kliniczny we Wroclawiu

    Wroclaw, 50 556

Other trials in Poland

Mexico3 sites

  • Medicos Especialistas en Cancer, S.C.

    Aguascalientes, 20230

  • Centro Estatal de Cancerología de Chihuahua

    Chihuahua City, 31000

  • Oncologia Integral Satelite

    Naucalpan, 53100

Other trials in Mexico

Netherlands3 sites

  • Antoni van Leeuwenhoek

    Amsterdam, 1066 CX

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3430 EM

  • Haga ziekenhuis

    The Hague, 2545 CH

Other trials in Netherlands

About this study

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

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).

Read the 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.

Being tested
Erdafitinib, Vinflunine, Docetaxel, Pembrolizumab, Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErdafitinibDrug

    Also called JNJ-42756493

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

  • VinflunineDrug

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

  • DocetaxelDrug

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

  • PembrolizumabDrug

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

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

    FGFRi CTA will be used to determine molecular eligibility.

Study groups in NCT03390504
Study groupRoleWhat they receive
Cohort 1 (Arm 1A): ErdafitinibExperimentalParticipants 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.
Receives: Drug: Erdafitinib; Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
Cohort 1 (Arm 1B): Vinflunine or DocetaxelExperimentalParticipants 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.
Receives: Drug: Vinflunine; Drug: Docetaxel; Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
Cohort 2 (Arm 2A): ErdafitinibExperimentalParticipants 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.
Receives: Drug: Erdafitinib; Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
Cohort 2 (Arm 2B): PembrolizumabExperimentalParticipants 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.
Receives: Drug: Pembrolizumab; Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall survival was measured from the date of randomization to the date of the participant's death.

    Measured: From randomization (3 days prior to Cycle 1 Day 1) until death due to any cause (maximum up to 51.7 months)

Secondary outcomes (20)

  1. 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.

    Measured: 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)

  2. 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.

    Measured: From start of the treatment (Day 1 Cycle 1) up to maximum of 51.7 months

  3. 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.

    Measured: Baseline up to Cycle 11 (each cycle was of 21 days)

  4. 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.

    Measured: Randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months

  5. 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.

    Measured: Baseline, 51.7 months

  6. 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.

    Measured: Baseline up to Cycle 11 (each cycle was of 21 days)

  7. 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.

    Measured: Baseline up to Cycle 11 (each cycle was of 21 days)

  8. 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.

    Measured: From date of first documented response to date of first documented PD or death whichever occurred first (maximum up to 51.7 months)

  9. 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.

    Measured: 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)

  10. 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.

    Measured: From baseline up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (maximum up to 51.7 months)

  11. 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.

    Measured: From baseline up to 30 days after last dose or start of new anticancer therapy, whichever occurred first (maximum up to 51.7 months)

  12. 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.

    Measured: Day 1 of Cycle 2 and 4 (Each Cycle 21 days)

  13. 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.

    Measured: Baseline, 51.7 months

  14. 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.

    Measured: From baseline up to maximum of 51.7 months

  15. 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.

    Measured: From baseline up to maximum of 51.7 months

  16. 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.

    Measured: From baseline up to maximum of 51.7 months

  17. 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.

    Measured: From baseline up to maximum of 51.7 months

  18. 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.

    Measured: From baseline up to maximum of 51.7 months

  19. 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.

    Measured: Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle was of 21 days)

  20. 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.

    Measured: Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle is of 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2018
  2. Study start23 Mar 2018
  3. Primary completion15 Apr 2024
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
629 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03390504
Sponsor's protocol ID
CR108401
Other IDs
42756493BLC3001, 2017-002932-18, 2023-510296-56-00, 2023, 2017
Acronym
THOR
Status last verified
Nov 2026
First submitted
20 Dec 2017
Last updated
3 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Expanded access
Available

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.

    PubMed 37870920

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erdafitinib, Vinflunine and Docetaxel in people with Urothelial Cancer, run by Janssen Research & Development, LLC at 345 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 345 sites in Russia, Italy, United States, China, France and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From randomization (3 days prior to Cycle 1 Day 1) until death due to any cause (maximum up to 51.7 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03390504, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in