RecruitingPhase 3NCT06319820

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

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

Sponsor

Janssen Research & Development, LLC

Enrollment

641 participants

Start Date

Apr 18, 2024

Study Type

INTERVENTIONAL

Conditions

Non-Muscle Invasive Bladder Neoplasms

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests TAR-210, a device that slowly releases a cancer drug directly inside the bladder, compared to standard single-agent bladder treatments for patients with non-muscle-invasive bladder cancer (cancer that has not grown deep into the bladder wall) that keeps coming back. **You may be eligible if...** - You have been diagnosed with intermediate-risk non-muscle-invasive bladder cancer (NMIBC) confirmed within the past 90 days - Your cancer falls into certain categories: low-grade tumors that are primary or recurrent, or tumors with specific risk features like multiple tumors, large tumor size, or frequent recurrence **You may NOT be eligible if...** - Your bladder cancer has grown into the muscle layer - You have high-grade bladder cancer - You have certain other medical conditions or organ problems that disqualify you - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTTAR-210

TAR-210 will be administered intravesically.

DRUGGemcitabine

Gemcitabine will be administered intravesically.

DRUGMMC

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

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

Mercy Research

St Louis, Missouri, United States

Specialty Clinical Research of St Louis

St Louis, Missouri, 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)

CABA, 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

Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria

Universitaetsklinikum Salzburg Landeskrankenhaus

Salzburg, Austria

Medical University Vienna MUV

Vienna, Austria

AZORG campus Aalst Moorselbaan

Aalst, Belgium

AZ Sint-Jan

Bruges, Belgium

UZ Antwerpen

Edegem, Belgium

AZ Maria Middelares

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

Associacao Hospitalar Moinhos de Vento

Porto Alegre, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

HBA SA Assitencia Medica e Hospitalar

Salvador, Brazil

Fundacao do ABC Centro Universitario FMABC

Santo André, Brazil

Irmandade Da 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

Cheng Du Shi, China

West China School of Medicine/West China Hospital, Sichuan University

Cheng Du Shi, 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

Xi'an, 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

APHP - Hopital Bichat - Claude Bernard

Paris, France

Clinique de la Croix du Sud

Quint-Fonsegrives, France

Chu Rennes Hopital Pontchaillou

Rennes, France

CHU Rangueil

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Charite - Universitaetsmedizin Berlin (CCM)

Berlin, Germany

Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie

Braunschweig, Germany

Studienzentrum Bayenthal

Cologne, Germany

Urologische Gemeinschaftspraxis

Dresden, Germany

Universitaetsklinikum Frankfurt

Frankfurt am Main, Germany

Urologikum Hamburg MVZ - Germany

Hamburg, Germany

Marien hospital Herne

Herne, Germany

Universitatsklinikum Jena

Jena, Germany

Klinikum rechts der Isar an der Technischen Universitat Munchen

München, Germany

Klinikum St. Elisabeth Straubing GmbH

Straubing, Germany

Katharinenhospital Innere Medizin

Stuttgart, Germany

Prince Of Wales Hospital

Hong Kong, Hong Kong

Queen Mary Hospital

Hong Kong, Hong Kong

Cork University Hospital

Cork, Ireland

Mater Misericordiae University Hospital

Dublin, Ireland

Mater Private Hospital

Dublin, Ireland

Adelaide and Meath Hospital

Dublin, Ireland

Rambam Health Care Campus

Haifa, Israel

Hadassah University Hospita Ein Kerem

Jerusalem, Israel

Sheba Medical Center

Ramat Gan, Israel

Ziv Medical Center

Safed, Israel

Sourasky Medical Center

Tel Aviv, Israel

Ospedale S. Donato Arezzo, USL 8 - U.O. Oncologia Medica

Arezzo, Italy

Cliniche Humanitas Gavazzeni

Bergamo, Italy

ASST Spedali Civili Brescia

Brescia, Italy

Ospedale San Raffaele

Milan, Italy

Istituto Dei Tumori Di Milano

Milan, Italy

Universita Campus Bio-Medico di Roma

Roma, Italy

Istituto Nazionale Tumori Regina Elena

Roma, Italy

Istituto Clinico Humanitas

Rozzano, Italy

A.O.Citta della Salute e della Scienza di Torino

Torino, Italy

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki Shi, Japan

St Marianna University Hospital

Kawasaki Shi, Japan

Kobe City Medical Center General Hospital

Kobe, Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, Japan

Osaka International Cancer Institute

Osaka, Japan

Gunma Prefectural Cancer Center

Ōta-ku, Japan

Saitama Medical Center

Saitama, Japan

JRC Wakayama Medical Center

Wakayama, Japan

Yokohama Municipal Citizen's Hospital

Yokohama, Japan

Yokohama City University Medical Center

Yokohama, Japan

Yokosuka Kyosai Hospital

Yokosuka, Japan

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland

IN VIVO Sp. z o.o

Bydgoszcz, Poland

Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy

Bydgoszcz, Poland

Uniwersytecki Szpital Kliniczny nr 4

Lublin, Poland

Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

Przemyśl, Poland

Szpital Wojewodzki Im Sw Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie

Tarnów, Poland

Medicover Integrated Clinical Services Sp z o o

Torun, Poland

Mazowiecki Szpital Onkologiczny Sp z o o

Wieliszew, Poland

4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu

Wroclaw, Poland

Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii

Wroclaw, Poland

Chungbuk National University Hospital

Chungcheongbuk Do, South Korea

National Cancer Center

Gyeonggi-do, South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Hosp Univ A Coruna

A Coruña, Spain

Hosp. Univ. de La Ribera

Alzira, Spain

Fund. Puigvert

Barcelona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp. Puerta Del Mar

Cadiz, Spain

Hosp. Gral. Univ. de Castellon

Castellon, Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

Clinica Univ. de Navarra

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp Virgen de La Victoria

Málaga, Spain

Hosp. Univ. Central de Asturias

Oviedo, Spain

Hosp.Univ.Parc Tauli

Sabadell, Spain

Hosp. Virgen Del Rocio

Seville, Spain

Hosp. Clinico Univ. de Valencia

Valencia, Spain

Adana Baskent Practice and Research Hospital

Adana, Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, Turkey (Türkiye)

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi

Istanbul, Turkey (Türkiye)

Kartal Dr Lutfi Kirdar sehir Hastanesi

Istanbul, Turkey (Türkiye)

Dokuz Eylul University Medical Faculty

Izmir, Turkey (Türkiye)

Southmead Hospital

Bristol, United Kingdom

St Bartholomews Hospital

London, United Kingdom

Charing Cross Hospital

London, United Kingdom

Newcastle Freeman Hospital

Newcastle upon Tyne, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom

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NCT06319820

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