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NCT06919965PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

9/10/2025

Completion Date

3/16/2032

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 Criteria

Age Range: 18 years to No maximum

Inclusion criteria: * Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded * Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determined by central or local testing * All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomization. For participants with lamina propria invasion (T1) on the screening biopsy/TURBT, muscularis propria must be present to rule out MIBC * Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population); b. had adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or c. been unable to complete an induction course of BCG with at least 5 doses due to grade \>= 2 toxicity requiring BCG discontinuation (BCG intolerant population) * Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2 * Must be ineligible for or refusing radical cystectomy (RC) Exclusion criteria: * Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is \[i.e.\], T2, T3, T4, N+, and/or M+) * Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or prior malignancies: a. Any malignancy that was not progressing nor requiring treatment change in the last 12 months; b. Malignancies treated within the last 12 months and considered at very low risk for recurrence for example (e.g.): non-melanoma skin cancers (treated with curative therapy or localized melanoma treated with curative surgical resection alone), non-invasive cervical cancer, breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer and receiving antihormonal agents), localized prostate cancer (\[N0, M0\] with a Gleason score less than or equal to \[\<=\] 7a, treated locally only \[radical prostatectomy/radiation therapy/focal treatment\]) and other malignancy that is considered at minimal risk of recurrence * Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 210 * A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\>) 4,000 milliliters (mL) * Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

Interventions

DRUG

TAR-210

DRUG

Mitomycin C

DRUG

Gemcitabine

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Conditions

Non-Muscle Invasive Bladder Neoplasms

Locations

Academic Urology and Urogynecology of Arizona

Sun City, Arizona 85351

United States

UCLA

Los Angeles, California 90095

United States

Colorado Clinical Research

Lakewood, Colorado 80228

United States

Advanced Urology Institute

Largo, Florida 33771

United States

Georgia Urology

Atlanta, Georgia 30328

United States

Associated Urological Specialists

Chicago Ridge, Illinois 60415

United States

Urology of Indiana

Carmel, Indiana 46032

United States

Southern Urology LLC

Lafayette, Louisiana 70508

United States

Greater Boston Urology

Plymouth, Massachusetts 02360

United States

Comprehensive Urology

Royal Oak, Michigan 48073

United States

UroHealth Partners

Omaha, Nebraska 68114

United States

New Jersey Urology LLC

Voorhees Township, New Jersey 08043

United States

Associated Medical Professionals

Syracuse, New York 13210

United States

Dayton Physicians Network Urology

Centerville, Ohio 45459

United States

The Urology Group

Cincinnati, Ohio 45212

United States

Helios Clinical Research, LLC

Middleburg Heights, Ohio 44130

United States

Oregon Urology Institute

Springfield, Oregon 97477

United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania 19004

United States

Keystone Urology Specialists

Lancaster, Pennsylvania 17604

United States

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina 29572

United States

The Conrad Pearson Clinic

Germantown, Tennessee 38138

United States

Texas Oncology-Austin

Austin, Texas 78731

United States

Urology Austin

Austin, Texas 78745

United States

Urology San Antonio PA dba USA Clinical Trials

San Antonio, Texas 78229

United States

Hospital Sirio Libanes

Buenos Aires, C1419AHN

Argentina

Instituto Alexander Fleming

Buenos Aires, C1426ANZ

Argentina

Investigaciones Clinico Moleculares (ICM)

Caba, C1425

Argentina

Centro Urologico Profesor Bengio

Córdoba, X5000KPH

Argentina

Sanatorio de la Mujer

Rosario, 2000

Argentina

Hopital Erasme

Brussels, 1070

Belgium

Ziekenhuis Oost-Limburg

Genk, 3600

Belgium

AZ Maria Middelares

Ghent, 9000

Belgium

Universitair Ziekenhuis Leuven

Leuven, 3000

Belgium

Algemeen Ziekenhuis Delta

Roeselare, 8800

Belgium

Liga Norte Riograndense Contra O Cancer

Natal, 59062 000

Brazil

Hospital Regional do Cancer - Hospital de Esperanca

Presidente Prudente, 19013-050

Brazil

Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto

São José do Rio Preto, 15090 000

Brazil

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

São Paulo, 01246 000

Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, 01323 010

Brazil

Peking University First Hospital

Beijing, 100034

China

The Third People's Hospital of Chengdu

Chengdu, 610014

China

West China Hospital Sichuan University

Chengdu, 610093

China

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

Guangzhou, 510260

China

Nanjing Drum Tower Hospital

Nanjing, 210008

China

The First Affiliated Hospital of Ningbo University

Ningbo, 315020

China

The Second Hospital Of Tianjin Medical University

Tianjin, 300211

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000

China

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

Wuhan, 430030

China

Institut Paoli Calmettes

Marseille, 13009

France

Hopital Saint Louis

Paris, 75010

France

CHU Pitie Salpetriere

Paris, 75013

France

Hopital Saint Joseph

Paris, 75014

France

Clinique de la Croix du Sud

Quint-Fonsegrives, 31130

France

CHP Saint Gregoire

Saint-Grégoire, 35768

France

Gustave Roussy

Villejuif, 94800

France

Universitaetsklinikum Koeln

Cologne, 50937

Germany

Marien hospital Herne

Herne, 44625

Germany

Klinikum Leverkusen gGmbH

Leverkusen, 51375

Germany

Universitaetsklinikum Mannheim

Mannheim, 68167

Germany

Studienpraxis Urologie Nurtingen

Nürtingen, 72622

Germany

Caritas-Krankenhaus St. Josef

Regensburg, 93053

Germany

General Hospital of Athens G Gennimatas

Athens, 115 27

Greece

Laiko General Hospital of Athens

Athens, 115 27

Greece

Sismanogleio General Hospital

Athens, 15126

Greece

General Hospital Of Thessaloniki Papageorgiou

Thessaloniki, 56429

Greece

Athens Medical Center S A Interbalkan Medical Center of Thessaloniki

Thessaloniki, 57001

Greece

Rambam Medical Center

Haifa, 3109601

Israel

Carmel Medical Center

Haifa, 3436212

Israel

Meir Medical Center

Kfar Saba, 44281

Israel

Rabin Medical Center

Petah Tikva, 4941492

Israel

Sheba Medical Center

Ramat Gan, 52621

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239

Israel

Cliniche Humanitas Gavazzeni

Bergamo, 24125

Italy

ASST Spedali Civili Brescia

Brescia, 25123

Italy

SPDC Villa Scassi

Genova, 16149

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Fondazione G Pascale Istituto Nazionale Tumori IRCCS

Naples, 80131

Italy

Istituto Nazionale Tumori Regina Elena

Roma, 00144

Italy

Aou San Luigi Gonzaga

Sanatorio San Luigi, 10043

Italy

Ospedale S. Maria Della Misericordia

Udine, 33100

Italy

Juntendo University Hospital

Bunkyō City, 113 8431

Japan

Funabashi Municipal Medical Center

Funabashi Shi, 273 8588

Japan

Hakodate Goryoukaku Hospital

Hakodate, 040 8611

Japan

St Marianna University Hospital

Kawasaki, 216 8511

Japan

The Jikei University Hospital

Minatoku, 105 8471

Japan

Toho University Sakura Medical Center

Sakura, 285-8741

Japan

Yokohama Municipal Citizen's Hospital

Yokohama, 221 0855

Japan

Yokohama City University Medical Center

Yokohama, 232 0024

Japan

Radboud Umcn

Nijmegen, 6525 GA

Netherlands

Canisius-Wilhelmina ZH

Nijmegen, 6532 SZ

Netherlands

Erasmus MC

Rotterdam, 3015

Netherlands

UMC Utrecht

Utrecht, 3584 CX

Netherlands

Chungbuk National University Hospital

Cheongju-si, 28644

South Korea

Samsung Medical Center

Gangnam Gu, 06351

South Korea

Seoul National University Bundang Hospital

Seongnam-si, 13620

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Hosp Univ A Coruna

A Coruña, 15006

Spain

Hosp. Clinic de Barcelona

Barcelona, 08036

Spain

Hosp. Puerta Del Mar

Cadiz, 11009

Spain

Hosp. Gral. Univ. de Castellon

Castellon, 12004

Spain

Hosp. Arquitecto Marcide

Ferrol, 15405

Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Hosp Virgen de La Victoria

Málaga, 29010

Spain

Hosp.Univ.Parc Tauli

Sabadell, 08208

Spain

Hull University Teaching Hospitals NHS Trust

Cottingham, HU16 5JQ

United Kingdom

St Bartholomews Hospital

London, EC1A 7BE

United Kingdom

Southampton University Hospital

Southampton, SO16 6HU

United Kingdom

Lister Hospital

Stevenage, SG1 4AB

United Kingdom

Royal Marsden Hospital

Surrey, SM2 5PT

United Kingdom