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)
Running, not enrolling · Phase 3
Conditions studied: Non-Muscle Invasive Bladder Neoplasms
In brief
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.
Key facts
- Study ID
- NCT06211764
- Run by
- Janssen Research & Development, LLC
- People needed
- 272
- Starts
- 2024-04-09
- Expected to finish
- 2031-04-14
- Last updated by the study team
- 2026-07-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Genesis Research LLC 1 — Los Alamitos, California, United States
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
- University of California Irvine Medical Center — Orange, California, United States
- University of California San Francisco — San Francisco, California, United States
- Genesis Research LLC — Torrance, California, United States
- Colorado Clinical Research — Lakewood, Colorado, United States
- Florida Urology Partners — Riverview, Florida, United States
- Northwestern University — Chicago, Illinois, United States
- UroPartners — Chicago Ridge, Illinois, United States
- Urology of Indiana — Carmel, Indiana, United States
- First Urology, PSC — Jeffersonville, Indiana, United States
- Wichita Urology Group — Wichita, Kansas, United States
- Comprehensive Urology — Royal Oak, Michigan, United States
- Specialty Clinical Research of St Louis — St Louis, Missouri, United States
- Associated Medical Professionals — Syracuse, New York, United States
- The Urology Group — Cincinnati, Ohio, United States
- Central Ohio Urology Group — Gahanna, Ohio, United States
- Centers for Advanced Urology LLC d b a MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States
- Ralph H. Johnson Veterans Affairs Medical Center — Charleston, South Carolina, United States
- Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
- Low Country Urology Clinics — North Charleston, South Carolina, United States
- Urology Associates — Nashville, Tennessee, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Urology Austin — Austin, Texas, United States
- Arkansas Urology — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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