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)

February 12, 2026 updated by: Janssen Research & Development, LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Británico 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 Câncer
      • 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
        • Fakultni Nemocnice u sv. Anny v Brne
      • Liberec, Czechia, 460 63
        • Krajská nemocnice Liberec
      • Prague, Czechia, 128 08
        • Vseobecna Fakultni 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
        • Hôpital Charles Nicolle
      • Saint-Grégoire, France, 35760
        • CHP Saint Grégoire
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cohort 1: Recurrence-Free Survival (RFS)
Time Frame: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cohort 1: Recurrence-Free Survival Rate at 6 Months and 12 Months
Time Frame: At Month 6 and Month 12
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 Frame: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months
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
Time Frame: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months
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)
Time Frame: From start of treatment (Day 1) up to 25.2 months
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
Time Frame: 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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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