Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Non-Muscle Invasive Bladder Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2031
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT06211764
Start Date
April 9 2024
End Date
April 14 2031
Last Update
December 5 2025
Active Locations (123)
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1
Arkansas Urology
Little Rock, Arkansas, United States, 72211
2
Genesis Research LLC
Los Alamitos, California, United States, 90720
3
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
4
University of California Irvine Medical Center
Orange, California, United States, 92868