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)

A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions

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.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder Neoplasms
• Intervention / Treatment: Drug: Erdafitinib; Drug: Investigator Choice (Gemcitabine); Drug: Investigator Choice (Mitomycin C)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Hospital Britanico de Buenos Aires
  • Buenos Aires, Argentina, C1419AHN
    • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
  • Buenos Aires, Argentina, C1431FWN
    • CEMIC Saavedra
  • Ciudad Autonoma de, Argentina, C1199ABB
    • Hospital Italiano de Buenos Aires
  • Córdoba, Argentina, 5000
    • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • Córdoba, Argentina, X5000KPH
    • Centro Urologico Profesor Bengio
  • Córdoba, Argentina, XX5016KEH
    • Hospital Privado de Cordoba
• Australia
  • Bedford Park, Australia, 5042
    • Flinders Medical Centre
  • Darlinghurst, Australia, 2010
    • St Vincent s Hospital Sydney
  • Macquarie University, Australia, 2109
    • Macquarie University
  • Melbourne, Australia, 3000
    • Peter MacCallum Cancer Centre
• Belgium
  • Ghent, Belgium, 9000
    • AZ Maria Middelares
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liège, Belgium, 4000
    • CHU Sart-Tilman
  • Roeselare, Belgium, 8800
    • Algemeen Ziekenhuis Delta
• Brazil
  • Curitiba, Brazil, 81520 060
    • Liga Paranaense de Combate ao Cancer
  • Fortaleza, Brazil, 60135-237
    • Oncocentro Ceará
  • Goiânia, Brazil, 74605-070
    • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
  • Natal, Brazil, 59075-740
    • Liga Norte Riograndense Contra O Cancer
  • Porto Alegre, Brazil, 90050-170
    • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre, Brazil, 91350 200
    • Hospital Nossa Senhora da Conceicao S A
  • Recife, Brazil, 50070-550
    • Instituto de Medicina Integral Professor Fernando Figueira
  • Ribeirão Preto, Brazil, 14048-900
    • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
  • Rio de Janeiro, Brazil, 22250 905
    • Oncoclinicas Rio de Janeiro S A
  • Rio de Janeiro, Brazil, 22775 001
    • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • Santo André, Brazil, 09060-650
    • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
  • São Paulo, Brazil, 01308 901
    • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
  • São Paulo, Brazil, 04039-004
    • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
  • São Paulo, Brazil, 01246 000
    • Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
• China
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Shanghai, China, 200240
    • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Wuhan, China, 430030
    • Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
• Czechia
  • Brno, Czechia, 656 91
    • Fakultní nemocnice u sv. Anny v Brne
  • Liberec, Czechia, 460 63
    • Krajská nemocnice Liberec
  • Prague, Czechia, 128 08
    • Všeobecná fakultní nemocnice v Praze
  • Prague, Czechia, 150 06
    • Fakultni nemocnice v Motole
• France
  • Bordeaux, France, 33076
    • Hopital Pellegrin CHU Bordeaux
  • Clermont-Ferrand, France, 63000
    • CHU Gabriel-Montpied
  • Lille, France, 59037
    • Hôpital Huriez
  • Lyon, France, 69437
    • Hôpital Edouard Herriot
  • Marseille, France, 13273
    • Institut Paoli Calmettes
  • Paris, France, 75013
    • Hôpital Universitaire Pitié-Salpêtrière
  • Paris, France, 75877
    • Hopital Bichat Claude Bernard
  • Paris, France, 75020
    • Groupe Hospitalier Diaconesses Croix Saint Simon
  • Poitiers, France, 86021
    • CHU De Poitiers
  • Rennes, France, 35033
    • Chu Rennes Hopital Pontchaillou
  • Rouen, France, 76031
    • Hopital Charles Nicolle
  • Saint-Grégoire, France, 35760
    • CHP Saint Gregoire
  • Toulouse, France, 31000
    • Institut Universitaire du Cancer Toulouse Oncopole
  • Vandœuvre-lès-Nancy, France, 54519
    • Centre Hospitalier Universitaire de Nancy - Hôpital Central
  • Villejuif, France, 94800
    • Gustave Roussy
• Germany
  • Duisburg, Germany, 47169
    • Urologicum Duisburg
  • Herne, Germany, 44625
    • Klinikum Herne - Urologie
  • Lübeck, Germany, 23538
    • Universitatsklinikum Schleswig Holstein Campus Lubeck
  • Mülheim, Germany, 45468
    • Praxisklinik Urologie Rhein/Ruhr - Germany
  • München, Germany, 81675
    • Klinikum rechts der Isar - III. Med. Klinik und Poliklinik
  • Münster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Nuremberg, Germany, 90491
    • MVZ Urologie 24 gGmbH
  • Nürtingen, Germany, 72622
    • Studienpraxis Urologie Drs. Feyerabend
  • Wesseling, Germany, 50389
    • CUROS - Uberörtliche urologische Gemeinschaftspraxis
• India
  • Bangalore, India, 560027
    • Health Care Global Enterprises pvt Ltd
  • Delhi, India, 110085
    • Rajiv Gandhi Cancer Institute & Research Centre
  • Lucknow, India, 226003
    • King Georges Medical University
  • Madurai, India, 625107
    • Meenakshi Mission Hospital and Research Center
  • Nadiād, India, 387001
    • Muljibhai Patel Urological Hospital
  • Pune, India, 411040
    • CIMET s Inamdar Multispeciality Hospital
• Italy
  • Acquaviva delle Fonti, Italy, 70021
    • Ente Ecclesiastico Ospedale Generale Regionale F. Miulli
  • Aosta, Italy, 11100
    • Ospedale Regionale Umberto Parini
  • Cefalù, Italy, 90015
    • Fondazione Istituto G. Giglio
  • Guastalla, Italy, 42016
    • Ospedale Civile di Guastalla
  • Lecce, Italy, 73100
    • Azienda Ospedaliera ''Vito Fazzi''
  • Macerata, Italy, 62100
    • UOC Oncologia Ospedale Provinciale di Macerata
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Milan, Italy, 20132
    • IRCCS Ospedale San Raffaele
  • Napoli, Italy, 80138
    • Fondazione G Pascale Istituto Nazionale Tumori IRCCS
  • Roma, Italy, 00189
    • Azienda Ospedaliera Sant Andrea
  • Verona, Italy, 37126
    • Azienda Ospedaliera Universitaria Integrata Verona
• Japan
  • Bunkyō City, Japan, 113 8519
    • Tokyo Medical and Dental University Hospital
  • Bunkyō City, Japan, 113 8431
    • Juntendo University Hospital
  • Chiba, Japan, 289-2511
    • Asahi General Hospital
  • Hakodate, Japan, 040 8611
    • Hakodate Goryoukaku Hospital
  • Hidaka, Japan, 350-1298
    • Saitama Medical University International Medical Center
  • Hitachi, Japan, 317-0077
    • Hitachi General Hospital
  • Kanagawa, Japan, 216 8511
    • St Marianna University Hospital
  • Nagoya, Japan, 466 8560
    • Nagoya University Hospital
  • Osaka, Japan, 591-8025
    • JOHAS Osaka Rosai Hospital
  • Takatsuki, Japan, 569-8686
    • Osaka Medical and Pharmaceutical University Hospital
  • Tokyo, Japan, 105-8470
    • Toranomon Hospital
  • Tokyo, Japan, 135 8550
    • The Cancer Institute Hospital of JFCR
  • Toyoake, Japan, 470-1192
    • Fujita Health University Hospital
  • Tsukuba, Japan, 305 8576
    • University of Tsukuba Hospital
  • Yokohama, Japan, 232 0024
    • Yokohama City University Medical Center
  • Ōta-ku, Japan, 373 8550
    • Gunma Prefectural Cancer Center
• Poland
  • Gdansk, Poland, 80 214
    • Uniwersyteckie Centrum Kliniczne
  • Krakow, Poland, 30-727
    • Pratia MCM Krakow
  • Rzeszów, Poland, 35-055
    • Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
  • Szczecin, Poland, 70-111
    • Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
  • Warsaw, Poland, 02-473
    • City Clinic Sp. z o.o.
  • Warsaw, Poland, 02 798
    • Medical Concierge Centrum Medyczne
  • Wroclaw, Poland, 50-556
    • Uniwersytecki Szpital Kliniczny
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Cheongju-si, South Korea, 361-711
    • Chungbuk National University Hospital
  • Daegu, South Korea, 41404
    • Kyungpook National University Chilgok Hospital
  • Goyang-si, South Korea, 10408
    • National Cancer Center
  • Jeollanam-do, South Korea, 58128
    • Chonnam National University Hwasun Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
• Spain
  • Barcelona, Spain, 08025
    • Fund. Puigvert
  • Barcelona, Spain, 8036
    • Hosp Clinic de Barcelona
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28034
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28046
    • Hosp. Univ. La Paz
  • Sabadell, Spain, 08208
    • Corporacio Sanitari Parc Tauli
  • Santander, Spain, 39008
    • Hosp. Univ. Marques de Valdecilla
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Chung Ho Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 33305
    • Chang Gung Memorial Hospital- Linkou
• United Kingdom
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust Christie Hospital
  • Sheffield, United Kingdom, S10 2JF
    • Universirty of Sheffield Teaching Hospitals NHS Trust
  • Stevenage, United Kingdom, SG1 4AB
    • Lister Hospital
• United States
  • Arizona
    • Tucson, Arizona, United States, 85741
      • Urological Associates of Southern Arizona, P.C.
  • California
    • Los Angeles, California, United States, 90033
      • USC Institute of Urology
  • Colorado
    • Denver, Colorado, United States, 80211
      • The Urology Center of Colorado
  • Florida
    • Hialeah, Florida, United States, 33016
      • Urological Research Network
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Winship Cancer Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Springfield, Illinois, United States, 62702
      • Simmons Cancer Institute
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • New York, New York, United States, 10016
      • NYU Langone Health
    • Sanborn, New York, United States, 14132
      • Great Lakes Physician PC d/b/a Western New York Urology Associates
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • The Urology Group
    • Columbus, Ohio, United States, 43221
      • The Ohio State University- James Cancer Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • MidLantic Urology
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center - Cancer Centers
  • Tennessee
    • Nashville, Tennessee, United States, 37209
      • Urology Associates
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
  • Washington
    • Seattle, Washington, United States, 98008
      • University of Washington
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin Froedtert Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. 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 BCG experienced 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 representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
• A woman of childbearing potential must have a negative pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) (urine or serum) within 7 days before randomization (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 Criteria:

• Histologically confirmed, muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder
• Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous 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 only allowed exceptions are: (a) skin cancer treated within the last 24 months that is considered completely cured (b) adequately treated lobular carcinoma in situ (LCIS) and ductal CIS (c) history of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy
• Current central serous retinopathy or retinal pigment epithelial detachment of any grade

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Erdafitinib; Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ [CIS], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy will receive treatment with erdafitinib.	Drug: Erdafitinib; Participants will receive erdafitinib orally beginning on Cycle 1 Day 1 until 2 years of treatment have been completed, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurs first. Each cycle is of 28 days.; Other Names: JNJ-42756493
Experimental: Cohort 2; Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor will receive treatment with erdafitinib.	Drug: Erdafitinib; Participants will receive erdafitinib orally beginning on Cycle 1 Day 1 until 2 years of treatment have been completed, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurs first. Each cycle is of 28 days.; Other Names: JNJ-42756493
Experimental: Cohort 3; Marker lesion study in intermediate-risk NMIBC presenting as papillary disease only. All enrolled participants will receive treatment with erdafitinib.	Drug: Erdafitinib; Participants will receive erdafitinib orally beginning on Cycle 1 Day 1 until 2 years of treatment have been completed, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurs first. Each cycle is of 28 days.; Other Names: JNJ-42756493
Active Comparator: Cohort 1: Investigators Choice; Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy will receive the investigator's choice of either intravesical gemcitabine or intravesical mitomycin C (MMC) or hyperthermic MMC. Participants who are randomized to gemcitabine or MMC or hyperthermic MMC in Cohort 1 and demonstrate a recurrence via investigator disease assessment will have the opportunity to cross over to treatment with erdafitinib.	Drug: Investigator Choice (Gemcitabine); Investigator's Choice treatment will be given once weekly for at least 4 doses of induction followed by monthly maintenance for at least 6 months.; Drug: Investigator Choice (Mitomycin C); Investigator's Choice treatment will be given once weekly for at least 4 doses of induction followed by monthly maintenance for at least 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Recurrence-Free Survival (RFS)	RFS was defined as the time from the date of randomization until the date of the reappearance of high-risk disease (high-grade Ta, T1 or carcinoma in situ [CIS]), or death, whichever was reported first. Recurrence was assessed using cystoscopy, bladder mapping, urine cytology, and computed tomography (CT)/ magnetic resonance imaging (MRI) urogram. Participants who were recurrence-free and alive or had unknown status were censored at the last tumor assessment. The Kaplan-Meier method was used to estimate the distribution of overall RFS for each treatment group.	From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Recurrence-Free Survival Rate at 6 Months and 12 Months	RFS rate was the proportion of participants who were recurrence-free and alive based on Kaplan-Meier estimates. RFS was defined as the time from the date of randomization until the date of the reappearance of high-risk disease (high-grade Ta, T1 or CIS), or death, whichever was reported first. Recurrence was assessed using cystoscopy, bladder mapping, urine cytology, and CT/ MRI urogram. Participants who were recurrence-free and alive or had unknown status were censored at the last tumor assessment.	At Month 6 and Month 12
Cohort 1: Time to Progression	Time to progression (TTP) was defined as the time from the date of randomization until the date of first documented evidence of any of the following: disease progression (PD) or death. PD included development of or increase in stage to lamina propria invasion (for example- increase from Ta to T1), development of or increase in stage to muscle-invasive disease (stage greater than or equal to [>=] T2), development of or increase in stage to lymph node (N+) or distant metastasis (M1) disease (participants must have previously been diagnosed with N0 and/or M0 disease), increase in tumor grade from low to high (including CIS).	From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months
Cohort 1: Overall Survival	Overall survival was defined as the time from the date of randomization to the date of the participant's death due to any cause.	From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were the events between first dose of study drug and up to 30 (+7 days) days after last dose or before start of subsequent anticancer therapy, whichever occurred first. All TEAEs including serious and non-serious events were reported in this outcome measure (OM).	From start of treatment (Day 1) up to 25.2 months
Plasma Concentrations of Erdafitinib	Plasma concentrations of erdafitinib were reported. Plasma samples were analyzed using liquid chromatography/mass spectrometry method.	All cohorts: Pre-dose on Cycle 1 Day 14, pre-dose and 3 hours post-dose on Cycle 2 Day 1 (each cycle was of 28 days)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Han MA, Maisch P, Jung JH, Hwang JE, Narayan V, Cleves A, Hwang EC, Dahm P. Intravesical gemcitabine for non-muscle invasive bladder cancer. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD009294. doi: 10.1002/14651858.CD009294.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2020
• Primary Completion (Actual): July 12, 2024
• Study Completion (Actual): February 27, 2025

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Non muscle invasive bladder cancer (NMIBC); Bacillus calmette- guerin (BCG) failure; BCG unresponsive
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Quinones; Azirines; Mitomycins; Indolequinones; Gemcitabine; Mitomycin; erdafitinib
• Other Study ID Numbers: CR108699; 2019-002449-39 (EudraCT Number); 42756493BLC2003 (Other Identifier: Janssen Research & Development, LLC); 2023-510306-40-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No