RecruitingPhase 3NCT06919965

A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)

Sponsor

Janssen Research & Development, LLC

Enrollment

220 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

Non-Muscle Invasive Bladder Neoplasms

Summary

The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new intravesical drug-releasing device called TAR-210 against standard chemotherapy instilled directly into the bladder for people with high-risk, non-muscle-invasive bladder cancer. TAR-210 slowly releases a targeted therapy (erdafitinib) inside the bladder over time. **You may be eligible if...** - You have high-risk bladder cancer that has not grown into the muscle wall - Your tumor has a specific genetic change in a protein called FGFR - All visible tumors have been surgically removed before the study starts - Your urine tests do not show signs of high-grade cancer remaining **You may NOT be eligible if...** - Your cancer has spread into the muscle or beyond the bladder - Your tumor does not have an FGFR mutation - You have previously received FGFR-targeted therapy - 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

DRUGTAR-210

TAR-210 will be administered intravesically.

DRUGMitomycin C

MMC will be administered intravesically.

DRUGGemcitabine

Gemcitabine will be administered intravesically.

Locations(104)

Colorado Clinical Research

Lakewood, Colorado, United States

Georgia Urology

Atlanta, Georgia, United States

Associated Urological Specialists

Chicago Ridge, Illinois, United States

Urology of Indiana

Carmel, Indiana, United States

Greater Boston Urology

Plymouth, Massachusetts, United States

Comprehensive Urology

Royal Oak, Michigan, United States

UroHealth Partners

Omaha, Nebraska, United States

New Jersey Urology LLC

Voorhees Township, New Jersey, United States

Associated Medical Professionals

Syracuse, New York, United States

Dayton Physicians Network Urology

Centerville, Ohio, United States

The Urology Group

Cincinnati, Ohio, United States

Helios Clinical Research, LLC

Middleburg Heights, Ohio, United States

Oregon Urology Institute

Springfield, Oregon, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

MidLantic Urology

Lancaster, Pennsylvania, United States

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

The Conrad Pearson Clinic

Germantown, Tennessee, United States

Urology Austin

Austin, Texas, United States

Urology San Antonio PA dba USA Clinical Trials

San Antonio, Texas, United States

Hospital Sirio Libanes

Buenos Aires, Argentina

Instituto Alexander Fleming

Buenos Aires, Argentina

Investigaciones Clinico Moleculares (ICM)

Caba, Argentina

Centro Urologico Profesor Bengio

Córdoba, Argentina

Sanatorio de la Mujer

Rosario, Argentina

Hopital Erasme

Brussels, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

AZ Maria Middelares

Ghent, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

Algemeen Ziekenhuis Delta

Roeselare, Belgium

Liga Norte Riograndense Contra O Cancer

Natal, Brazil

Hospital Regional do Cancer - Hospital de Esperança

Presidente Prudente, Brazil

Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto

São José do Rio Preto, Brazil

Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo

São Paulo, Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, Brazil

Peking University First Hospital

Beijing, China

The Third People's Hospital of Chengdu

Chengdu, China

West China Hospital Sichuan University

Chengdu, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, China

Nanjing Drum Tower Hospital

Nanjing, China

The First Affiliated Hospital of Ningbo University

Ningbo, China

The Second Hospital Of Tianjin Medical University

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

Wuhan, China

Institut Paoli Calmettes

Marseille, France

Hopital Saint Louis

Paris, France

CHU Pitie Salpetriere

Paris, France

Hopital Saint Joseph

Paris, France

Clinique de la Croix du Sud

Quint-Fonsegrives, France

CHP Saint Gregoire

Saint-Grégoire, France

Gustave Roussy

Villejuif, France

Universitaetsklinikum Koeln

Cologne, Germany

Marien hospital Herne

Herne, Germany

Klinikum Leverkusen gGmbH

Leverkusen, Germany

Universitaetsklinikum Mannheim

Mannheim, Germany

Studienpraxis Urologie Nurtingen

Nürtingen, Germany

Caritas-Krankenhaus St. Josef

Regensburg, Germany

General Hospital of Athens G Gennimatas

Athens, Greece

Laiko General Hospital of Athens

Athens, Greece

Sismanogleio General Hospital

Athens, Greece

General Hospital Of Thessaloniki Papageorgiou

Thessaloniki, Greece

Athens Medical Center S A Interbalkan Medical Center of Thessaloniki

Thessaloniki, Greece

Rambam Medical Center

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Meir Medical Center

Kfar Saba, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Cliniche Humanitas Gavazzeni

Bergamo, Italy

ASST Spedali Civili Brescia

Brescia, Italy

SPDC Villa Scassi

Genova, Italy

Ospedale San Raffaele

Milan, Italy

Fondazione G Pascale Istituto Nazionale Tumori IRCCS

Naples, Italy

Istituto Nazionale Tumori Regina Elena

Roma, Italy

Ospedale S. Maria Della Misericordia

Udine, Italy

Juntendo University Hospital

Bunkyō City, Japan

Funabashi Municipal Medical Center

Funabashi Shi, Japan

Hakodate Goryoukaku Hospital

Hakodate, Japan

St Marianna University Hospital

Kawasaki, Japan

The Jikei University Hospital

Minatoku, Japan

Toho University Sakura Medical Center

Sakura, Japan

Yokohama Municipal Citizen's Hospital

Yokohama, Japan

Yokohama City University Medical Center

Yokohama, Japan

Radboud Umcn

Nijmegen, Netherlands

Canisius-Wilhelmina ZH

Nijmegen, Netherlands

Chungbuk National University Hospital

Cheongju-si, South Korea

Samsung Medical Center

Gangnam Gu, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Hosp Univ A Coruna

A Coruña, Spain

Hosp. Clinic de Barcelona

Barcelona, Spain

Hosp. Puerta Del Mar

Cadiz, Spain

Hosp. Gral. Univ. de Castellon

Castellon, Spain

Hosp. Arquitecto Marcide

Ferrol, Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp Virgen de La Victoria

Málaga, Spain

Hosp.Univ.Parc Tauli

Sabadell, Spain

Hull University Teaching Hospitals NHS Trust

Cottingham, United Kingdom

St Bartholomews Hospital

London, United Kingdom

Southampton University Hospital

Southampton, United Kingdom

Lister Hospital

Stevenage, United Kingdom

Royal Marsden Hospital

Surrey, United Kingdom

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NCT06919965

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