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RECRUITING
NCT06319820
PHASE3

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

Interventions

COMBINATION_PRODUCT

TAR-210

TAR-210 will be administered intravesically.

DRUG

Gemcitabine

Gemcitabine will be administered intravesically.

DRUG

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

And 93 more locations on ClinicalTrials.gov