Last updated 15 days ago
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)
250 patients around the world
Available in Brazil, Argentina, United States
Janssen Research & Development, LLC
5Research sites
250Patients around the world
This study is for people with
Bladder Cancer
Non-muscle-invasive bladder cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Centro Urológico Profesor Bengió - Córdoba
Recruiting
Hospital Privado de la Comunidad
Recruiting
Centro Gutman
Recruiting
AC Camargo Cancer Center
Recruiting
StudySunRISe-5
SponsorJanssen Research & Development, LLC
Conditions
Non-muscle-invasive bladder cancerBladder Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06211764
