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RECRUITING

NCT06919965

PHASE3

A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive 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 (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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2025-09-10

Completion Date

2032-03-16

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

DRUG

TAR-210

TAR-210 will be administered intravesically.

DRUG

Mitomycin C

MMC will be administered intravesically.

DRUG

Gemcitabine

Gemcitabine will be administered intravesically.

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

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (104)