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Clinical Trials in the UK / NCT06211764
Active, not recruiting Phase 3

A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

NCT06211764 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2024-04-09
Last updated
2026-08-28

Condition(s) studied

Non-Muscle Invasive Bladder Neoplasms

Investigational drug(s) / intervention(s)

TAR-200Mitomycin CGemcitabine

TAR-200: Participants will receive TAR-200 intravesically.

Mitomycin C: Participants will receive MMC intravesically.

Gemcitabine: Participants will receive gemcitabine intravesically.

Study summary

The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) \[defined as high-grade Ta or any T1, no carcinoma in situ (CIS)\] * Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded * Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC) * Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2 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, T2, T3, T4, N+, and/or M+) * 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-200. Participants with tumors involving the prostatic urethra in men will be excluded * A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (\>4000 mL) * Indwelling catheters are not permitted; however, intermittent catheterization is acceptable * Previous treatment with TAR-200

Primary outcome measure(s)

Trial sites (123)

FacilityCityRegionStatus
Arkansas Urology Little Rock Arkansas
Genesis Research LLC 1 Los Alamitos California
USC Norris Comprehensive Cancer Center Los Angeles California
University of California Irvine Medical Center Orange California
University of California San Francisco San Francisco California
Genesis Research LLC Torrance California
Colorado Clinical Research Lakewood Colorado
Florida Urology Partners Riverview Florida
Northwestern University Chicago Illinois
UroPartners Chicago Ridge Illinois
Urology of Indiana Carmel Indiana
First Urology, PSC Jeffersonville Indiana
Wichita Urology Group Wichita Kansas
Comprehensive Urology Royal Oak Michigan
Specialty Clinical Research of St Louis St Louis Missouri
Associated Medical Professionals Syracuse New York
The Urology Group Cincinnati Ohio
Central Ohio Urology Group Gahanna Ohio
Centers for Advanced Urology LLC d b a MidLantic Urology Bala-Cynwyd Pennsylvania
Ralph H. Johnson Veterans Affairs Medical Center Charleston South Carolina
Carolina Urologic Research Center Myrtle Beach South Carolina
Low Country Urology Clinics North Charleston South Carolina
Urology Associates Nashville Tennessee
Vanderbilt University Medical Center Nashville Tennessee
Urology Austin Austin Texas
Urology Clinics of North Texas Dallas Texas
University of Texas Southwestern Medical Center Dallas Texas
Houston Metro Urology Houston Texas
Spokane Urology Spokane Washington
Clinica Santa Isabel 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
AZ Sint-Jan Bruges Belgium
Cliniques Universitaires Saint Luc Brussels Belgium
Ziekenhuis Oost-Limburg Genk Belgium
Algemeen ziekenhuis Maria Middelares Ghent Belgium
Algemeen Ziekenhuis Delta Roeselare Belgium
Fundacao Pio XII Barretos Brazil

+ 83 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06211764 on ClinicalTrials.gov ↗ ← All trials in the UK