Bladder Cancer Clinical Trial

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)

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

250

Study ID:

NCT06211764

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 35 Locations for this study

See Locations Near You

Arkansas Urology
Little Rock Arkansas, 72211, United States
Genesis Research LLC
Los Alamitos California, 90720, United States
Genesis Research LLC
Torrance California, 90503, United States
Colorado Clinical Research
Lakewood Colorado, 80228, United States
Florida Urology Partners
Riverview Florida, 33578, United States
Urology of Indiana
Carmel Indiana, 46032, United States
First Urology, PSC
Jeffersonville Indiana, 47130, United States
Comprehensive Urology
Royal Oak Michigan, 48073, United States
Specialty Clinical Research of St Louis
Saint Louis Missouri, 63141, United States
Associated Medical Professionals
Syracuse New York, 13210, United States
The Urology Group
Cincinnati Ohio, 45212, United States
Central Ohio Urology Group
Gahanna Ohio, 43230, United States
Centers for Advanced Urology LLC d b a MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Low Country Urology Clinics
North Charleston South Carolina, 29406, United States
Urology Associates
Nashville Tennessee, 37209, United States
Urology Austin
Austin Texas, 78745, United States
Houston Metro Urology
Houston Texas, 77027, United States
Clinica Santa Isabel
Buenos Aires , C1406, Argentina
Investigaciones Clinico Moleculares (ICM)
Caba , C1425, Argentina
Fundacao Antonio Prudente A C Camargo Cancer Center
Sao Paulo , 01509, Brazil
West China School of Medicine/West China Hospital, Sichuan University
Cheng Du Shi , 61004, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin , 30006, China
The Second Hospital of Tianjin Medical University
Tianjin , 30021, China
Funabashi Munitiple Medical Center
Chiba , 273-8, Japan
Hakodate Goryoukaku Hospital
Hakodate , 040-8, Japan
Toho University Sakura Medical Center
Sakura , 285-8, Japan
Chungbuk National University Hospital
Chungcheongbuk Do , 28644, Korea, Republic of
Keimyung University Dongsan Hospital
Daegu , 42601, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
St Bartholomews Hospital
London , EC1A , United Kingdom
Salford Royal Hospital
Salford , M6 8H, United Kingdom
Lister Hospital
Stevenage , SG1 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

250

Study ID:

NCT06211764

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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