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A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
Sponsor: Janssen Research & Development, LLC
Summary
The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.
Official title: A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
641
Start Date
2024-04-18
Completion Date
2032-12-31
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
TAR-210
TAR-210 will be administered intravesically.
Gemcitabine
Gemcitabine will be administered intravesically.
MMC
MMC will be administered intravesically.
Locations (193)
Arkansas Urology
Little Rock, Arkansas, United States
Genesis Research LLC
Los Alamitos, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California Irvine Medical Center
Orange, California, United States
Om Research LLC
San Diego, California, United States
Genesis Research LLC 1
Sherman Oaks, California, United States
University of Colorado Cancer Center Anschultz Cancer Pavilion
Aurora, Colorado, United States
Colorado Clinical Research
Lakewood, Colorado, United States
Mercy Research
San Luis, Colorado, United States
Specialty Clinical Research of St Louis
San Luis, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
First Urology
Jeffersonville, Indiana, United States
Wichita Urology Group
Wichita, Kansas, United States
Ochsner Health System
New Orleans, Louisiana, United States
Chesapeake Urology Research Associates
Hanover, Maryland, United States
Brigham And Women's Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Comprehensive Urology
Royal Oak, Michigan, United States
The Urology Center, PC
Omaha, Nebraska, United States
Cancer Institute Of New Jersey
New Brunswick, New Jersey, United States
Integrated Medical Professionals
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Associated Medical Professionals of Ny
Syracuse, New York, United States
SUNY Upstate Med Univ
Syracuse, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
The Conrad Pearson Clinic
Germantown, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Urology Associates
Nashville, Tennessee, United States
Urology Austin
Austin, Texas, United States
Urology Clinics of North Texas
Dallas, Texas, United States
UT Southwestern
Dallas, Texas, United States
Houston Metro Urology
Houston, Texas, United States
Spokane Urology
Spokane, Washington, United States
Hospital Sirio Libanes
Buenos Aires, Argentina
Investigaciones Clinico Moleculares (ICM)
Chabas, Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, Argentina
Centro Urologico Profesor Bengio
Córdoba, Argentina
Hospital Privado de la Comunidad
Mar del Plata, Argentina
Sanatorio de la Mujer
Rosario, Argentina
Medizinische Universitaet Graz
Graz, Austria
Medizinische Universitat Innsbruck
Innsbruck, Austria
Medical University Vienna MUV
Leopoldsdorf (Wien), Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, Austria
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, Austria
AZORG campus Aalst Moorselbaan
Aalst, Belgium
AZ Sint-Jan
Brugge (Bruges), Belgium
UZ Antwerpen
Edegem, Belgium
AZ Maria Middelares
Gent (Ghent), Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium
Vitaz
Sint-Niklaas, Belgium
CHU UCL Namur - Site Godinne
Yvoir, Belgium
Fundacao Pio XII
Barretos, Brazil
Universidade Estadual De Campinas
Campinas, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Brazil
Hospital Moinhos de Vento
Porto Alegre, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
HBA SA Assitencia Medica e Hospitalar
Salvador, Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, Brazil
Irmandade Santa Casa de Misericordia de Sao Paulo
São Paulo, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil
Beijing Friendship Hospital Capital Medical University
Beijing, China
Peking University Third Hospital
Beijing, China
Hunan Cancer hospital
Changsha, China
The Third People's Hospital of Chengdu
Chengdu, China
West China School of Medicine/West China Hospital, Sichuan University
Chengdu, China
Chongqing Cancer Hospital
Chongqing, China
Fujian Medical University Union Hospital
Fuzhou, China
Sun Yat Sen University Cancer Center
Guangzhou, China
Nanjing Drum Tower Hospital
Nanjing, China
Zhongda Hospital Southeast University
Nanjing, China
Huadong Hospital Affiliated to Fudan University
Shanghai, China
The Second Hospital Of Tianjin Medical University
Tianjin, China
Cancer Hospital of Xinjiang Medical University
Ürümqi, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
The First Affiliated Hospital of Xian Jiaotong University
Xinshi, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni nemocnice Olomouc
Olomouc, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Fakultni Thomayerova nemocnice
Prague, Czechia
Fakultni nemocnice v Motole
Prague, Czechia
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Odense Universitetshospital
Odense, Denmark
Zealand University Hospital
Roskilde, Denmark
Hospital Center University De Lille
Lille, France
Polyclinique de Limoges - Francois Chenieux
Limoges, France
Hôpital Edouard Herriot
Lyon, France
Institut Paoli Calmettes
Marseille, France
Hopital Saint Louis
Paris, France
CHU Pitie Salpetriere
Paris, France