NCT03473743Active, not recruitingPhase 1/2
A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer
A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 125 (actual)
- First submitted
- 14 Mar 2018
- Start date
- 5 Apr 2018
- Primary completion date
- 30 Sept 2022
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Bladder cancer
- NCT number
- NCT03473743
- EU CT number
- 2023-510295-31-00
- EudraCT number
- 2017-001980-19
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 125
- From 5 Apr 2018 to the primary completion date, 30 Sept 2022
- 127 sites in 13 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
- Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, participants who have received the following prior antitumor therapy: received nitrosoureas and mitomycin C within 6 weeks
- Phase 1b erdafitinib + cetrelimab cohort: Chemotherapy within 3 weeks of Cycle 1 Day 1; Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort and Phase 2: Prior neoadjuvant/adjuvant chemotherapy is allowed if the last dose was given \>12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation
- Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant/adjuvant checkpoint inhibitor therapy is allowed if the last dose was given more than (\>)12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation. PD-1 for non-muscle invasive bladder cancer is also allowed
- Active malignancies requiring concurrent therapy other than urothelial cancer
Other
- Symptomatic central nervous system metastases
Who the study is looking for
- Histologic demonstration of transitional cell carcinoma of the urothelium. Variant urothelial carcinoma histologies such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
- Metastatic or locally advanced urothelial cancer
- Must have measurable disease by radiological imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline
- Prior systemic therapy for metastatic urothelial cancer: (a) For Phase 1b erdafitinib + cetrelimab cohort: Any number of lines of prior therapy; (b) For Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: No prior systemic therapy for metastatic disease; and renal function for participants must have a creatinine clearance (CrCl) greater than (\>) 30 milliliter per minute (mL/min) to receive carboplatin and \>60 mL/min to receive cisplatin as calculated by Cockcroft Gault and (c) Phase 2: No prior systemic therapy for metastatic disease and cisplatin-ineligible based on: ECOG PS 0-1 and at least one of the following criteria: Renal function defined as creatinine clearance (CrCl) less than (˂) 60 mL/min as calculated by Cockcroft-Gault; Grade 2 or higher peripheral neuropathy per NCI-CTCAE version 5.0; Grade 2 or higher hearing loss per NCI-CTCAE version 5.0 OR ECOG PS 2
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: (a) Phase 1b erdafitinib + cetrelimab cohort: ECOG 0-2; (b) Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: ECOG 0-1 for cisplatin and 0-2 for carboplatin (c) Phase 2: ECOG 0-2
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (127)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| ULB Hôpital Erasme Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Jolimont Coordinator of this site? Confirm its status | Haine-Saint-Paul | Belgium | Unknown status |
| AZ Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Unknown status |
| CHU de Liège - Domaine Universitaire du Sart Tilman Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| AZ Nikolaas - Campus Sint-Niklaas Moerland Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Unknown status |
| GZA Ziekenhuizen- Campus St Augustinus Coordinator of this site? Confirm its status | Wilrijk | Belgium | Unknown status |
| Fundacao Pio XII Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Santa Casa de Misericordia de Belo Horizonte Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Liga Paranaense de Combate ao Cancer Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Oncocentro Servicos Medicos e Hospitalares Ltda - Oncocentro Coordinator of this site? Confirm its status | Fortaleza | 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 |
| Brest Regional Oncology Dispensary Coordinator of this site? Confirm its status | Brest | Belarus | Unknown status |
| Grodno University Hospital Coordinator of this site? Confirm its status | Grodno | Belarus | Unknown status |
| Gomel Regional Clinical Oncology Dispensary Coordinator of this site? Confirm its status | Homyel | Belarus | Unknown status |
| State Institution N.N. Alexandrov Republican Scientific and Coordinator of this site? Confirm its status | Lesnoy | Belarus | Unknown status |
| Minsk city Clinical Oncological Dispensary Coordinator of this site? Confirm its status | Minsk | Belarus | Unknown status |
| Mogilev Regional Hospital Coordinator of this site? Confirm its status | Mogilev | Belarus | Unknown status |
| Vitebsk Regional Clinical Hospital Coordinator of this site? Confirm its status | Vitebsk | Belarus | Unknown status |
| Hosp Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Univ. Ramon Y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Clinico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp Univ Hm Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp Univ Fund Jimenez Diaz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp Virgen de La Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Complexo Hosp. Univ. de Ourense Coordinator of this site? Confirm its status | Ourense | Spain | Unknown status |
| Complejo Hospitalario de Vigo Coordinator of this site? Confirm its status | Pontevedra | Spain | Unknown status |
| Hosp. Quiron Madrid Pozuelo Coordinator of this site? Confirm its status | Pozuelo de Alarcón | 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 |
| H. Clinico Universitario de Santiago de Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hosp. Virgen Del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hosp. Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hosp. Clinico Univ. de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Instituto Valenciano de Oncologia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Institut de Cancerologie de Ouest (ICO) Site Paul Papin Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Hôpital Saint-André Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre Hospitalier Saint Louis Coordinator of this site? Confirm its status | La Rochelle | France | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| APHM - Hôpital Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Clinique Sainte Anne Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| CHRU de Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Institut de Cancérologie de Lorraine Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Royal Lancaster Infirmary Coordinator of this site? Confirm its status | Lancaster | United Kingdom | Unknown status |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Cliniche Humanitas Gavazzeni Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Istituto di Candiolo, IRCCS Coordinator of this site? Confirm its status | Candiolo | Italy | Unknown status |
| Ospedale Di Zona B Ramazzini Coordinator of this site? Confirm its status | Carpi | Italy | Unknown status |
| UOS Oncologia Medica, A.O. Cannizzaro Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Arcispedale S. Anna Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
| PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco Coordinator of this site? Confirm its status | Lecco | Italy | Unknown status |
| Ospedale Civile di Livorno Coordinator of this site? Confirm its status | Livorno | Italy | Unknown status |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
| AUSL di Piacenza-Ospedale Guglielmo Da Saliceto Coordinator of this site? Confirm its status | Piacenza | Italy | Unknown status |
| Campus Bio Medico di Roma Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Azienda Socio Sanitaria Territoriale (ASST) della Valtellin Coordinator of this site? Confirm its status | Sondrio | Italy | Unknown status |
| Azienda Ospedaliera S.Maria - Terni Coordinator of this site? Confirm its status | Terni | Italy | Unknown status |
| Azienda Ospedaliero Universitaria S.Maria Della Misericordia Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
| The Catholic University of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Kangbuk Samsung 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 Metropolitan Government Seoul National University Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Seoul St Marys Hospital 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 |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Unknown status |
| Przychodnia Lekarska Komed Roman Karaszewski Coordinator of this site? Confirm its status | Konin | Poland | Unknown status |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| LUX MED Onkologia Sp. z.o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Centralny Szpital Kliniczny MSWiA w Warszawie Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Altai Regional Oncology Dispensary Coordinator of this site? Confirm its status | Barnaul | Russia | Unknown status |
| Ivanovo regional oncology dispensary Coordinator of this site? Confirm its status | Ivanovo | Russia | Unknown status |
| GUZ Kursk Regional Oncology Dispensary Coordinator of this site? Confirm its status | Kislino Village | Russia | Unknown status |
| Leningrad Regional Oncology Dispensary Coordinator of this site? Confirm its status | Kuzmolovsky | Russia | Unknown status |
| City Clinical Hospital n.a. D.D.Pletnev Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Russian Scientific Center of Roentgenoradiology Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Moscow City Clinical Hospital # 62 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Clinical Diagnostic Centre of Nizhny Novgorod Region Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
| Privolzhsky District Medical Centre Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
| Clinical Oncology Dispensary Coordinator of this site? Confirm its status | Omsk | Russia | Unknown status |
| LLC Novaya Clinica Coordinator of this site? Confirm its status | Pyatigorsk | Russia | Unknown status |
| Russian Scientific Center of Radiology and Surgical Technologies Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Private Medical Institution Euromedservice Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Tambov Regional Oncology Clinical Dispansary Coordinator of this site? Confirm its status | Tambov | Russia | Unknown status |
| Multifunctional clinical medical center 'Medical city' Coordinator of this site? Confirm its status | Tyumen | Russia | Unknown status |
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Memorial Hospital, Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Rocky Mountain Cancer Centers Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Levine Cancer Institute, Carolinas HealthCare System Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Texas Oncology, P.A. Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Penn State Hershey Cancer Institute Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Norton Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Weill Cornell Medical College-NY Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Virginia Oncology Associates Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Maryland Oncology Hematology, PA Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| Toledo Clinic Cancer Centers Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| White Plains Hospital - Center for Cancer Care Coordinator of this site? Confirm its status | White Plains | United States | Unknown status |
| Adana Acibadem Hospital Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Memorial Ankara Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Hacettepe University Medical Faculty Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Adnan Menderes University Training and Research Hospital Coordinator of this site? Confirm its status | Aydin | Turkey (Türkiye) | Unknown status |
| Trakya University Medical Faculty Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Unknown status |
| Istanbul University Cerrahpasa Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Istanbul Medeniyet University Goztepe Training and Research Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Ege University Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Kocaeli University Medical Faculty Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Unknown status |
| Necmettin Erbakan University Meram Medical Faculty Coordinator of this site? Confirm its status | Konya | Turkey (Türkiye) | Unknown status |
| Karadeniz Teknik University Medical Faculty Coordinator of this site? Confirm its status | Trabzon | Turkey (Türkiye) | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.