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A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer
Sponsor: Janssen Research & Development, LLC
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
125
Start Date
2018-04-05
Completion Date
2026-12-31
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Erdafitinib
Participants will receive erdafitinib orally.
Cetrelimab
Participants will receive cetrelimab by intravenous infusion.
Cisplatin
Participants will receive cisplatin by intravenous infusion as a part of platinum chemotherapy.
Carboplatin
Participants will receive carboplatin by intravenous infusion as a part of platinum chemotherapy.
Locations (127)
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Maryland Oncology Hematology, PA
Rockville, Maryland, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Weill Cornell Medical College - NY Presbyterian Hospital
New York, New York, United States
White Plains Hospital Center for Cancer Care
White Plains, New York, United States
Levine Cancer Institute, Carolinas HealthCare System
Charlotte, North Carolina, United States
Toledo Clinic Cancer Centers
Toledo, Ohio, United States
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States
Texas Oncology, P.A.
Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Brest Regional Oncology Dispensary
Brest, Belarus
Grodno University Hospital
Grodno, Belarus
Gomel Regional Clinical Oncology Dispensary
Homyel, Belarus
State Institution N.N. Alexandrov Republican Scientific and
Lesnoy, Belarus
Minsk city Clinical Oncological Dispensary
Minsk, Belarus
Mogilev Regional Hospital
Mogilev, Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, Belarus
ULB Hôpital Erasme
Brussels, Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
Jolimont
Haine-Saint-Paul, Belgium
Az Groeninge
Kortrijk, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium
AZ Nikolaas - Campus Sint-Niklaas Moerland
Sint-Niklaas, Belgium
GZA Ziekenhuizen- Campus St Augustinus
Wilrijk, Belgium
Fundacao Pio XII
Barretos, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, Brazil
Oncocentro Servicos Medicos e Hospitalares Ltda - Oncocentro
Fortaleza, 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
Institut de Cancerologie de Ouest (ICO) Site Paul Papin
Angers, France
Hopital Saint André
Bordeaux, France
Centre Francois Baclesse
Caen, France
Centre hospitalier Saint Louis
La Rochelle, France
Centre Leon Berard
Lyon, France
APHM Hopital Timone
Marseille, France
Hopital Europeen Georges Pompidou
Paris, France
Clinique Sainte Anne
Strasbourg, France
CHRU de Tours
Tours, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
Villejuif, France
Cliniche Humanitas Gavazzeni
Bergamo, Italy
Istituto di Candiolo, IRCCS
Candiolo, Italy
Ospedale Di Zona B Ramazzini
Carpi, Italy
UOS Oncologia Medica, A.O. Cannizzaro
Catania, Italy
Arcispedale S. Anna Ferrara
Ferrara, Italy
PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco
Lecco, Italy
Ospedale Civile Di Livorno
Livorno, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica
Perugia, Italy
AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto
Piacenza, Italy
Campus Bio Medico di Roma
Roma, Italy
Azienda Socio Sanitaria Territoriale (ASST) della Valtellin
Sondrio, Italy
Azienda Ospedaliera S. Maria Terni
Terni, Italy
Azienda Ospedaliero Universitaria S.Maria Della Misericordia
Udine, Italy
Przychodnia Lekarska KOMED Roman Karaszewski
Konin, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, Poland
LUX MED Onkologia Sp. z o.o.
Warsaw, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, Poland
Altai Regional Oncology Dispensary
Barnaul, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, Russia
GUZ Kursk Regional Oncology Dispensary
Kislino Village, Russia
Leningrad Regional Oncology Dispensary
Kuzmolovsky, Russia
City Clinical Hospital n.a. D.D.Pletnev
Moscow, Russia
Russian Scientific Center of Roentgenoradiology
Moscow, Russia
Moscow City Clinical Hospital # 62
Moscow, Russia
Clinical Diagnostic Centre of Nizhny Novgorod Region
Nizhny Novgorod, Russia
Privolzhsky District Medical Centre
Nizhny Novgorod, Russia
Clinical Oncology Dispensary
Omsk, Russia
LLC Novaya Clinica
Pyatigorsk, Russia
Private Medical Institution Euromedservice
Saint Petersburg, Russia
Russian Scientific Center of Radiology and Surgical Technologies
Saint Petersburg, Russia
Tambov Regional Oncology Clinical Dispansary
Tambov, Russia
Multifunctional clinical medical center 'Medical city'
Tyumen, Russia
Chungnam National University Hospital
Daejeon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
The Catholic university of Korea, St. Vincent's Hospital
Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
Hosp. Del Mar
Barcelona, Spain
Hosp Clinic de Barcelona
Barcelona, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, Spain
Hosp. Clinico San Carlos
Madrid, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, Spain
Hosp Univ Hm Sanchinarro
Madrid, Spain
Hosp Virgen de La Victoria
Málaga, Spain
Complexo Hosp. Univ. de Ourense
Ourense, Spain
Complejo Hospitalario de Vigo
Pontevedra, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, Spain
Corporacio Sanitari Parc Tauli
Sabadell, Spain
Hosp. Univ. Marques de Valdecilla
Santander, Spain
H. Clinico Universitario de Santiago de Compostela
Santiago de Compostela, Spain
Hosp. Virgen Macarena
Seville, Spain
Hosp. Virgen Del Rocio
Seville, Spain
Instituto Valenciano de Oncologia
Valencia, Spain
Hosp. Clinico Univ. de Valencia
Valencia, Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan District, Taiwan
Adana Acibadem Hospital
Adana, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, Turkey (Türkiye)
Adnan Menderes University Training and Research Hospital
Aydin, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey (Türkiye)
Istanbul Medeniyet University Goztepe Training and Research Hospital
Istanbul, Turkey (Türkiye)
Ege University
Izmir, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty
Konya, Turkey (Türkiye)
Karadeniz Teknik University Medical Faculty
Trabzon, Turkey (Türkiye)
Royal Lancaster Infirmary
Lancaster, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
University College London Hospitals Nhs Foundation Trust
London, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom