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A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-\[L\]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).
Official title: A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
629
Start Date
2018-03-23
Completion Date
2027-12-31
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Erdafitinib
Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.
Vinflunine
Participants will receive vinflunine 320 mg/m\^2 as a 20-minute intravenous infusion.
Docetaxel
Participants will receive docetaxel 75 mg/m\^2 as a 1 hour intravenous infusion.
Pembrolizumab
Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.
Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
FGFRi CTA will be used to determine molecular eligibility.
Locations (345)
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, United States
University of Calif Davis Medical Center
Sacramento, California, United States
St. Helena Hospital - Martin-O'Neil Cancer Center
St. Helena, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Miami Sylvester Cancer Center
Miami, Florida, United States
Mid Florida Hematology Oncology
Orange, Florida, United States
Piedmont Cancer Institute
Atlanta, Georgia, United States
Rush University
Chicago, Illinois, United States
Edward Hines Jr V A Hospital
Hines, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Maryland Oncology Hematology, PA
Lanham, Maryland, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
VA Sierra Nevada Health Care System
Reno, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Weill Cornell Medical College
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Levine Cancer Institute, Carolinas HealthCare System
Charlotte, North Carolina, United States
W G Bill Hefner VA Medical Center
Salisbury, North Carolina, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Texas Oncology-Memorial City
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology Tyler
Tyler, Texas, United States
INOVA Dwiight &Martha Schar Cancer Institute
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
VA Puget Sound Healthcare System
Seattle, Washington, United States
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Buenos Aires, Argentina
Centro Oncológico Korben
Buenos Aires, Argentina
CEMIC Saavedra
Buenos Aires, Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, Argentina
Centro Urologico Profesor Bengio
Córdoba, Argentina
Hospital Privado de Comunidad
Mar del Plata, Argentina
Centro de Investigacion Pergamino SA
Pergamino, Argentina
Clínica Viedma
Viedma, Argentina
Chris O'Brien Lifehouse
Camperdown, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Australia
St George Hospital
Kogarah, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
Frankston Hospital
Melbourne, Australia
Fiona Stanley Hospital
Murdoch, Australia
LKH-Univ. Klinikum Graz
Graz, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, Austria
Krankenhaus der Barmherzigen Brüder
Vienna, Austria
Medical University Vienna MUV
Vienna, Austria
OLV Ziekenhuis Aalst
Aalst, Belgium
ZNA Middelheim
Antwerp, Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
Clinique Notre Dame de Grâce
Charleroi, Belgium
AZ Maria Middelares
Ghent, Belgium
UZ Gent
Ghent, Belgium
CHC MontLegia
Liège, Belgium
Sint-Augustinus AZ
Wilrijk, Belgium
CHU UCL Namur - Site Godinne
Yvoir, Belgium
Fundacao Pio XII
Barretos, Brazil
Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, Brazil
Nucleo de Ensino e Pesquisa do Instituto Mario Penna
Belo Horizonte, Brazil
Instituto de Oncologia do Parana
Curitiba, Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, Brazil
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
Goiânia, Brazil
Clínica de Neoplasias Litoral Ltda.
Itajaí, Brazil
Fundacao Doutor Amaral Carvalho
Jaú, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, Brazil
Hospital Nossa Senhora da Conceicao S A
Porto Alegre, Brazil
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, Brazil
Hospital Sao Rafael
Salvador, Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes 1
São Paulo, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil
Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia
São Paulo, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Instituto de Oncologia de Sorocaba Onco Clinicas Especializadas
Sorocaba, Brazil
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, Bulgaria
Complex Oncology Center - Plovdiv EOOD
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'
Sofia, Bulgaria
UMHAT Sofia Med
Sofia, Bulgaria
Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD
Varna, Bulgaria
BC Cancer Agency - Southern Interior
Kelowna, British Columbia, Canada
Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Cancercare Manitoba
Winnipeg, Manitoba, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Princess Margaret Hospital- UHN
Toronto, Ontario, Canada
Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Peking University First Hospital
Beijing, China
Beijing Friendship Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Beijing Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
The First Bethune Hospital of Jilin University
Changchun, China
Sichuan Provincial Peoples Hospital
Chengdu, China
Sichuan University Huaxi Hospital
Chengdu, China
Chongqing University Cancer Hospital
Chongqing, China
Sun Yat Sen University Cancer Center
Guangzhou, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, China
Guangzhou First Municipal People's Hospital
Guangzhou, China