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)
NCT ID: NCT04172675
Last Updated: 2025-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
107 participants
INTERVENTIONAL
2020-02-28
2025-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
Cohort 2
Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor will receive treatment with erdafitinib.
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.
Cohort 3
Marker lesion study in intermediate-risk NMIBC presenting as papillary disease only. All enrolled participants will receive treatment with erdafitinib.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, United States
USC Institute of Urology
Los Angeles, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
Urological Research Network
Hialeah, Florida, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Simmons Cancer Institute
Springfield, Illinois, United States
University of Kansas
Westwood, Kansas, United States
Albany Medical College
Albany, New York, United States
NYU Langone Health
New York, New York, United States
Great Lakes Physician PC d/b/a Western New York Urology Associates
Sanborn, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
The Urology Group
Cincinnati, Ohio, United States
The Ohio State University- James Cancer Hospital
Columbus, Ohio, United States
Oregon Health And Science University
Portland, Oregon, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
University of Pittsburgh Medical Center - Cancer Centers
Pittsburgh, Pennsylvania, United States
Urology Associates
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
Medical College of Wisconsin Froedtert Hospital
Milwaukee, Wisconsin, United States
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Buenos Aires, , Argentina
CEMIC Saavedra
Buenos Aires, , Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de, , Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, , Argentina
Centro Urologico Profesor Bengio
Córdoba, , Argentina
Hospital Privado de Cordoba
Córdoba, , Argentina
Flinders Medical Centre
Bedford Park, , Australia
St Vincent s Hospital Sydney
Darlinghurst, , Australia
Macquarie University
Macquarie University, , Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
AZ Maria Middelares
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
CHU Sart-Tilman
Liège, , Belgium
Algemeen Ziekenhuis Delta
Roeselare, , Belgium
Liga Paranaense de Combate ao Cancer
Curitiba, , Brazil
Oncocentro Ceará
Fortaleza, , Brazil
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
Goiânia, , Brazil
Liga Norte Riograndense Contra O Cancer
Natal, , Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
Hospital Nossa Senhora da Conceicao S A
Porto Alegre, , Brazil
Instituto de Medicina Integral Professor Fernando Figueira
Recife, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirão Preto, , Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, , Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, , Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, , Brazil
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
São Paulo, , Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, , Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
São Paulo, , Brazil
Nanjing Drum Tower Hospital
Nanjing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, , China
Fakultni nemocnice u sv. Anny v Brne
Brno, , Czechia
Krajská nemocnice Liberec
Liberec, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Hopital Pellegrin CHU Bordeaux
Bordeaux, , France
CHU Gabriel-Montpied
Clermont-Ferrand, , France
Hopital Huriez
Lille, , France
Hôpital Edouard Herriot
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Hôpital Universitaire Pitié-Salpêtrière
Paris, , France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, , France
Hopital Bichat Claude Bernard
Paris, , France
CHU De Poitiers
Poitiers, , France
Chu Rennes Hopital Pontchaillou
Rennes, , France
Hopital Charles Nicolle
Rouen, , France
CHP Saint Gregoire
Saint-Grégoire, , France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, , France
Centre Hospitalier Universitaire de Nancy - Hôpital Central
Vandœuvre-lès-Nancy, , France
Gustave Roussy
Villejuif, , France
Urologicum Duisburg
Duisburg, , Germany
Klinikum Herne - Urologie
Herne, , Germany
Universitatsklinikum Schleswig Holstein Campus Lubeck
Lübeck, , Germany
Praxisklinik Urologie Rhein/Ruhr - Germany
Mülheim, , Germany
Klinikum rechts der Isar - III. Med. Klinik und Poliklinik
München, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
MVZ Urologie 24 gGmbH
Nuremberg, , Germany
Studienpraxis Urologie Drs. Feyerabend
Nürtingen, , Germany
CUROS - Uberörtliche urologische Gemeinschaftspraxis
Wesseling, , Germany
Health Care Global Enterprises pvt Ltd
Bangalore, , India
Rajiv Gandhi Cancer Institute & Research Centre
Delhi, , India
King Georges Medical University
Lucknow, , India
Meenakshi Mission Hospital and Research Center
Madurai, , India
Muljibhai Patel Urological Hospital
Nadiād, , India
CIMET s Inamdar Multispeciality Hospital
Pune, , India
Ente Ecclesiastico Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti, , Italy
Ospedale Regionale Umberto Parini
Aosta, , Italy
Fondazione Istituto G. Giglio
Cefalù, , Italy
Ospedale Civile di Guastalla
Guastalla, , Italy
Azienda Ospedaliera ''Vito Fazzi''
Lecce, , Italy
UOC Oncologia Ospedale Provinciale di Macerata
Macerata, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Napoli, , Italy
Azienda Ospedaliera Sant Andrea
Roma, , Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Juntendo University Hospital
Bunkyō City, , Japan
Tokyo Medical and Dental University Hospital
Bunkyō City, , Japan
Asahi General Hospital
Chiba, , Japan
Hakodate Goryoukaku Hospital
Hakodate, , Japan
Saitama Medical University International Medical Center
Hidaka, , Japan
Hitachi General Hospital
Hitachi, , Japan
St Marianna University Hospital
Kanagawa, , Japan
Nagoya University Hospital
Nagoya, , Japan
JOHAS Osaka Rosai Hospital
Osaka, , Japan
Gunma Prefectural Cancer Center
Ōta-ku, , Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, , Japan
Toranomon Hospital
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Fujita Health University Hospital
Toyoake, , Japan
University of Tsukuba Hospital
Tsukuba, , Japan
Yokohama City University Medical Center
Yokohama, , Japan
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Pratia MCM Krakow
Krakow, , Poland
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
Szczecin, , Poland
Medical Concierge Centrum Medyczne
Warsaw, , Poland
City Clinic Sp. z o.o.
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny
Wroclaw, , Poland
Pusan National University Hospital
Busan, , South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
National Cancer Center
Goyang-si, , South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Fund. Puigvert
Barcelona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Hosp. Univ. Ramon Y Cajal
Madrid, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp. Univ. La Paz
Madrid, , Spain
Corporacio Sanitari Parc Tauli
Sabadell, , Spain
Hosp. Univ. Marques de Valdecilla
Santander, , Spain
Instituto Valenciano de Oncologia
Valencia, , Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital- Linkou
Taoyuan, , Taiwan
The Christie NHS Foundation Trust Christie Hospital
Manchester, , United Kingdom
Universirty of Sheffield Teaching Hospitals NHS Trust
Sheffield, , United Kingdom
Lister Hospital
Stevenage, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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42756493BLC2003
Identifier Type: OTHER
Identifier Source: secondary_id
2019-002449-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-510306-40-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR108699
Identifier Type: -
Identifier Source: org_study_id
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