A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Last updated: April 8, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

2

Condition

Urothelial Cancer

Bladder Cancer

Treatment

Erdafitinib

Investigator Choice (Gemcitabine)

Investigator Choice (Mitomycin C)

Clinical Study ID

NCT04172675
CR108699
2023-510306-40-00
42756493BLC2003
2019-002449-39
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of thebladder. Variant pathology are allowed

  • Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions

  • Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCGexperienced participants

  • Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only)

  • Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-1

  • Must sign an informed consent form (ICF) (or their legally acceptable representativemust sign) indicating that he or she understands the purpose of, and proceduresrequired for, the study and is willing to participate in the study

  • A woman of childbearing potential must have a negative pregnancy test (beta-humanchorionic gonadotropin [beta-hCG]) (urine or serum) within 7 days beforerandomization (Cohort 1) or the first dose of study drug (Cohort 2 and Cohort 3)

  • Adequate bone marrow, liver, and renal function as specified in the protocol

Exclusion

Exclusion Criteria:

  • Histologically confirmed, muscle-invasive (T2 or higher stage) urothelial carcinomaof the bladder

  • Histopathology demonstrating any small cell component, pure adenocarcinoma, puresquamous cell carcinoma, or pure squamous CIS of the bladder

  • Prior treatment with an FGFR inhibitor

  • Active malignancies other than the disease being treated under study. The onlyallowed exceptions are: (a) skin cancer treated within the last 24 months that isconsidered completely cured (b) adequately treated lobular carcinoma in situ (LCIS)and ductal CIS (c) history of localized breast cancer and receiving antihormonalagents, or history of localized prostate cancer (N0M0) and receiving androgendeprivation therapy

  • Current central serous retinopathy or retinal pigment epithelial detachment of anygrade

Study Design

Total Participants: 107
Treatment Group(s): 3
Primary Treatment: Erdafitinib
Phase: 2
Study Start date:
February 28, 2020
Estimated Completion Date:
February 27, 2025

Study Description

This study enrolls participants with high risk NMIBC and FGFR mutations or fusions. Erdafitinib is an oral pan-fibroblast growth factor receptor (FGFR) 1-4 inhibitor with demonstrated clinical activity in participants with solid tumors, including urothelial carcinoma, with alterations in the FGFR pathway. In Cohort 1, participants will be randomized to erdafitinib or to Investigators Choice (intravesical gemcitabine or intravesical mitomycin C [MMC] or hyperthermic MMC). The study consists of screening period, treatment phase, follow-up phase, and long-term extension phase.

Connect with a study center

  • Hospital Britanico de Buenos Aires

    Buenos Aires,
    Argentina

    Site Not Available

  • Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

    Buenos Aires, C1419AHN
    Argentina

    Site Not Available

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    Buenos Aires, C1419AHN
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de, C1199ABB
    Argentina

    Site Not Available

  • CEMIC Saavedra

    Ciudad Autonoma de Buenos Aires, C1431FWN
    Argentina

    Site Not Available

  • Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Cordoba, 5000
    Argentina

    Site Not Available

  • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Cordoba, 5000
    Argentina

    Site Not Available

  • Centro Urologico Profesor Bengio

    Cordoba, X5000KPH
    Argentina

    Site Not Available

  • Hospital Privado de Cordoba

    Cordoba, XX5016KEH
    Argentina

    Site Not Available

  • Flinders Medical Centre

    Bedford, 5042
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, 5042
    Australia

    Site Not Available

  • St Vincent s Hospital Sydney

    Darlinghurst, 2010
    Australia

    Site Not Available

  • St. Vincent's Hospital Sydney

    Darlinghurst, 2010
    Australia

    Site Not Available

  • Macquarie University

    Macquarie University, 2109
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, 3000
    Australia

    Site Not Available

  • Newcastle Private Hospital

    New Lambton Heights, 2305
    Australia

    Site Not Available

  • ICON Cancer Care

    South Brisbane, 4101
    Australia

    Site Not Available

  • Sydney Adventist Hospital

    Wahroonga, 2076
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, 4102
    Australia

    Site Not Available

  • Cliniques Universitaires Saint Luc

    Brussel, 1200
    Belgium

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  • AZ Maria Middelares

    Gent, 9000
    Belgium

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  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • University Hospital Leuven

    Leuven Belgie, 00000
    Belgium

    Site Not Available

  • CHU Sart-Tilman

    Liege, 4000
    Belgium

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  • Algemeen Ziekenhuis Delta

    Roeselare, 8800
    Belgium

    Site Not Available

  • Centro de Pesquisa Urologica e Oncologia de Campinas

    Campinas, 13073-400
    Brazil

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  • Liga Paranaense de Combate ao Cancer

    Curitiba, 81520 060
    Brazil

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  • Oncocentro Ceará

    Fortaleza, 60135-237
    Brazil

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

    Goiania, 74605-070
    Brazil

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  • Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás

    Goiânia, 74605-070
    Brazil

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  • Liga Norte Riograndense Contra O Cancer

    Natal, 59075-740
    Brazil

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  • Hospital Nossa Senhora da Conceicao S A

    Porto Alegre, 91350 200
    Brazil

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    Porto Alegre, 91350-200
    Brazil

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    Porto Alegre, 90050-170
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    Recife, 50070-550
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    Ribeirão Preto, 14048-900
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    Ribeirão Preto, 14048-900
    Brazil

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    Rio de Janeiro, 22280-003
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    Rio de Janeiro, 22250 905
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    São Paulo, 01308 901
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    São Paulo, 01308 901
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    Nanjing, 210008
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    Shanghai, 200240
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    Rouen, 76031
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    Villejuif Cedex, 94800
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  • GFO Kliniken Rhein Berg

    Bergisch-Gladbach, 51465
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    Duisburg, 47169
    Germany

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  • Praxis Dr. med. Stefan Carl

    Emmendingen, 79312
    Germany

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  • Klinikum Herne - Urologie

    Herne, 44625
    Germany

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  • Universitatsklinikum Schleswig Holstein Campus Lubeck

    Lubeck, 23538
    Germany

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    Lubeck, 23538
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  • Klinikum rechts der Isar - III. Med. Klinik und Poliklinik

    Muenchen, 81675
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  • Universitaetsklinikum Muenster

    Muenster, 48149
    Germany

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  • Praxisklinik Urologie Rhein/Ruhr - Germany

    Mülheim, 45468
    Germany

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    Mülheim an der Ruhr, 45468
    Germany

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  • MVZ Urologie 24 gGmbH

    Nuernberg, 90491
    Germany

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  • Studienpraxis Urologie Drs. Feyerabend

    Nuertingen, 72622
    Germany

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  • CUROS - Uberörtliche urologische Gemeinschaftspraxis

    Wesseling, 50389
    Germany

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  • Health Care Global Enterprises pvt Ltd

    Bangalore, 560027
    India

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    Bikaner, 334003
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    Delhi, 110085
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    Jaipur, 302020
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    Kolkata, 700160
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    Lucknow, 226003
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    Lucknow, 226003
    India

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  • Meenakshi Mission Hospital and Research Center

    Madhurai, 625107
    India

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  • Tata Memorial Hospital

    Mumbai, 400012
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  • Muljibhai Patel Urological Hospital

    Nadiad, 387001
    India

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  • CIMET s Inamdar Multispeciality Hospital

    Pune, 411040
    India

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  • CIMET's Inamdar Multispeciality Hospital

    Pune, 411040
    India

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  • Ente Ecclesiastico Ospedale Generale Regionale F. Miulli

    Acquaviva delle Fonti, 70021
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    Aosta, 11100
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    Guastalla, 42016
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    Lecce, 73100
    Italy

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  • UOC Oncologia Ospedale Provinciale di Macerata

    Macerata, 62100
    Italy

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  • IRCCS Ospedale San Raffaele

    Milan, 20132
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  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milano, 20133
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  • Humanitas Centro Catanese di Oncologia

    Misterbianco/Catania, 95045
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  • Fondazione G Pascale Istituto Nazionale Tumori IRCCS

    Napoli, 80138
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  • Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS

    Napoli, 80138
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  • Azienda Ospedaliera Sant Andrea

    Roma, 00189
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  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126
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  • Asahi General Hospital

    Asahi, 289-2511
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    Bunkyo Ku, 113 8431
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    Bunkyo Ku, 113 8519
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    Bunkyo-Ku, 113-8431
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    Bunkyo-Ku, 113-8510
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    Chiba, 289-2511
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  • Hakodate Goryokaku Hospital

    Hakodate, 040-8611
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  • Hakodate Goryoukaku Hospital

    Hakodate, 040 8611
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  • Saitama Medical University International Medical Center

    Hidaka, 350-1298
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  • Hitachi General Hospital

    Hitachi, 317-0077
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  • St Marianna University Hospital

    Kanagawa, 216 8511
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  • St.Marianna University Hospital

    Kanagawa, 216-8511
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  • The Cancer Institute Hospital of JFCR

    Koto-ku, 135-8550
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  • Nagoya University Hospital

    Nagoya, 466 8560
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  • JOHAS Osaka Rosai Hospital

    Osaka, 591-8025
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  • Gunma Prefectural Cancer Center

    Ota, 373 8550
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  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686
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  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550
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  • Toranomon Hospital

    Tokyo, 105-8470
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    Toyoake, 470-1192
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  • University of Tsukuba Hospital

    Tsukuba City, 305 8576
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  • University of Tsukuba Hospital

    Tsukuba-City, 305-8576
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  • Yokohama City University Medical Center

    Yokohama, 232 0024
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  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

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  • Chungbuk National University Hospital

    Cheongju, 361-711
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  • Kyungpook National University Chilgok Hospital

    Daegu, 41404
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  • National Cancer Center

    Goyang si, 10408
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  • National Cancer Center

    Goyang-si, 10408
    Korea, Republic of

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  • National Cancer Center

    Goyangsi, 410-769
    Korea, Republic of

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  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128
    Korea, Republic of

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  • Kangbuk Samsung Hospital

    Seoul, 03181
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  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

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    Seoul, 06351
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    Seoul, 03080
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  • Severance Hospital Yonsei University Health System

    Seoul, 03722
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    Seoul, 03722
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  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214
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    Krakow, 30 727
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    Lodz, 93-411
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    Rzeszow, 35-055
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    Szczecin, 70-111
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    Shreveport, Louisiana 71106
    United States

    Site Not Available

  • MI Medicine

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Missouri

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Albany Medical College

    Albany, New York 12208
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Strong Memorial Hospital University of Rochester

    Rochester, New York 16442
    United States

    Site Not Available

  • Great Lakes Physician PC d/b/a Western New York Urology Associates

    Sanborn, New York 14132
    United States

    Site Not Available

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • The Urology Group

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • The Ohio State University- James Cancer Hospital

    Columbus, Ohio 43221
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health And Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

  • Lancaster Urology

    Lancaster, Pennsylvania 17604
    United States

    Site Not Available

  • University of Pittsburgh Medical Center - Cancer Centers

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Urology Associates

    Nashville, Tennessee 37209
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98008
    United States

    Site Not Available

  • William S. Middleton Memorial VA

    Madison, Wisconsin 53705
    United States

    Site Not Available

  • Medical College of Wisconsin Froedtert Hospital

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin-Froedtert Hospital

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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