NCT04172675CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 107 (actual)
- First submitted
- 20 Nov 2019
- Start date
- 28 Feb 2020
- Primary completion date
- 12 Jul 2024
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Bladder cancer
- NCT number
- NCT04172675
- EU CT number
- 2023-510306-40-00
- EudraCT number
- 2019-002449-39
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 107
- From 28 Feb 2020 to the primary completion date, 12 Jul 2024
- 123 sites in 17 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
- Current central serous retinopathy or retinal pigment epithelial detachment of any grade
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (123)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CEMIC Saavedra Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Britanico de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Sociedade Beneficente de Senhoras Hospital Sirio Libanes Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Ciudad Autonoma de | Argentina | Unknown status |
| Centro Urológico Profesor Bengió Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Hospital Privado de Cordoba Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Flinders Medical Centre Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| St Vincent's Hospital Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Macquarie University Coordinator of this site? Confirm its status | Macquarie University | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| AZ Maria Middelares Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| CHU Sart-Tilman Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Unknown status |
| Liga Paranaense de Combate ao Cancer Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Oncocentro Ceará Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge Coordinator of this site? Confirm its status | Goiânia | Brazil | Unknown status |
| Liga Norte Riograndense Contra o Cancer Coordinator of this site? Confirm its status | Natal | Brazil | Unknown status |
| Irmandade Santa Casa de Misericordia de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Nossa Senhora da Conceicao S A Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto de Medicina Integral Professor Fernando Figueira Coordinator of this site? Confirm its status | Recife | Brazil | Unknown status |
| Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Unknown status |
| Oncoclinicas Rio de Janeiro S A Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia Coordinator of this site? Confirm its status | Santo André | Brazil | Unknown status |
| Sociedade Beneficente de Senhoras Hospital Sirio Libanes Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Renji Hospital, Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Fakultni nemocnice u sv. Anny v Brne Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Krajská nemocnice Liberec Coordinator of this site? Confirm its status | Liberec | Czechia | Unknown status |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Coordinator of this site? Confirm its status | Herne | Germany | Completed |
| Hosp Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Fund. Puigvert Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Univ. La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Univ. 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Univ. Ramon Y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Corporacio Sanitari Parc Tauli Coordinator of this site? Confirm its status | Sabadell | Spain | Unknown status |
| Hosp. Univ. Marques de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Instituto Valenciano de Oncologia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Completed |
| The Christie NHS Foundation Trust - Christie Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Universirty of Sheffield Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Lister Hospital Coordinator of this site? Confirm its status | Stevenage | United Kingdom | Unknown status |
| Health Care Global Enterprises pvt Ltd Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Rajiv Gandhi Cancer Institute & Research Centre Coordinator of this site? Confirm its status | Delhi | India | Unknown status |
| King Georges Medical University Coordinator of this site? Confirm its status | Lucknow | India | Unknown status |
| Meenakshi Mission Hospital and Research Center Coordinator of this site? Confirm its status | Madurai | India | Unknown status |
| Muljibhai Patel Urological Hospital Coordinator of this site? Confirm its status | Nadiād | India | Unknown status |
| CIMET's Inamdar Multispeciality Hospital Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Ente Ecclesiastico Ospedale Generale Regionale F Miulli Coordinator of this site? Confirm its status | Acquaviva Delle Fonti | Italy | Unknown status |
| Ospedale Regionale Umberto Parini Coordinator of this site? Confirm its status | Aosta | Italy | Unknown status |
| Fondazione Istituto G. Giglio Coordinator of this site? Confirm its status | Cefalù | Italy | Unknown status |
| Ospedale Civile di Guastalla Coordinator of this site? Confirm its status | Guastalla | Italy | Unknown status |
| Azienda Ospedaliera ''Vito Fazzi'' Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione G Pascale Istituto Nazionale Tumori IRCCS Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| UOC Oncologia Ospedale Provinciale di Macerata Coordinator of this site? Confirm its status | Province of Macerata | Italy | Unknown status |
| Azienda Ospedaliera Sant Andrea Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Tokyo Medical and Dental University Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Asahi General Hospital Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Hakodate Goryoukaku Hospital Coordinator of this site? Confirm its status | Hakodate | Japan | Unknown status |
| Saitama Medical University International Medical Center Coordinator of this site? Confirm its status | Hidaka | Japan | Unknown status |
| Hitachi General Hospital Coordinator of this site? Confirm its status | Hitachi | Japan | Unknown status |
| St Marianna University Hospital Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Nagoya University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| JOHAS Osaka Rosai Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Gunma Prefectural Cancer Center Coordinator of this site? Confirm its status | Ōta-ku | Japan | Unknown status |
| Osaka Medical and Pharmaceutical University Hospital Coordinator of this site? Confirm its status | Takatsuki | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Toranomon Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Fujita Health University Hospital Coordinator of this site? Confirm its status | Toyoake | Japan | Unknown status |
| University of Tsukuba Hospital Coordinator of this site? Confirm its status | Tsukuba | Japan | Unknown status |
| Yokohama City University Medical Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Jeollanam-do | South Korea | Unknown status |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Memorial Hospital, Linkou Coordinator of this site? Confirm its status | Taoyuan County | Taiwan | Unknown status |
| Albany Medical College Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Emory University/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| MidLantic Urology Coordinator of this site? Confirm its status | Bala-Cynwyd | United States | Unknown status |
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| The Urology Group Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| The Ohio State University James Cancer Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| The Urology Center of Colorado Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Urological Research Network Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| USC Institute of Urology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Medical College of Wisconsin/ Froedtert Hospital Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Urology Associates Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pittsburgh Medical Center - Cancer Centers Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Great Lakes Physician PC d/b/a Western New York Urology Associates Coordinator of this site? Confirm its status | Sanborn | United States | Unknown status |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Simmons Cancer Institute Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Urological Associates of Southern Arizona, P.C. Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| University of Kansas Coordinator of this site? Confirm its status | Westwood | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.