Study Comparing TAR-210 and Chemotherapy for High-Risk Non-Muscle-Invasive Bladder Cancer
Sponsor: Janssen Research & Development, LLC
Sponsor score: 60
ClinicalTrials ID:NCT06919965
This clinical trial is comparing two treatments, TAR-210 and intravesical chemotherapy, to see which is more effective in preventing the return or progression of high-risk non-muscle-invasive bladder cancer.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The main goal of this study is to find out if TAR-210 or intravesical chemotherapy is better at keeping high-risk non-muscle-invasive bladder cancer from coming back or getting worse. Participants will receive either TAR-210 or a chemotherapy treatment chosen by their doctor, and researchers will track how long they remain free of cancer symptoms.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with specific tumor characteristics.
- Have a specific genetic mutation or fusion in the FGFR gene, confirmed by urine or tumor tissue testing.
- All visible tumors must be removed before starting the study, and urine tests must not show signs of high-grade cancer.
- Must have received a certain amount of BCG treatment in the past, or have been unable to complete BCG treatment due to side effects.
- Have a performance status score of 0, 1, or 2, indicating good overall health.
- Must not be eligible for or must refuse bladder removal surgery (radical cystectomy).
Exclusion Criteria
- Have had carcinoma in situ (CIS) or more advanced bladder cancer at any time.
- Have other active cancers that are progressing or have required treatment changes in the last 24 months, except for certain low-risk cancers.
- Have bladder or urethral conditions that could make it unsafe to use TAR-210.
- Have a history of excessive urination, with more than 4,000 mL of urine in 24 hours.
- Cannot have a permanent catheter, but occasional catheter use is allowed.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Colorado Clinical Research | 80228 | Lakewood | Colorado |
| Georgia Urology | 30328 | Atlanta | Georgia |
| Comprehensive Urology | 48073 | Royal Oak | Michigan |
| UroHealth Partners | 68114 | Omaha | Nebraska |
| Dayton Physicians Network Urology | 45459 | Centerville | Ohio |
| Helios Clinical Research, LLC | 44130 | Middleburg Heights | Ohio |
| Oregon Urology Institute | 97477 | Springfield | Oregon |
| MidLantic Urology | 19004 | Bala-Cynwyd | Pennsylvania |
| MidLantic Urology | 17604 | Lancaster | Pennsylvania |
| University Of Pittsburgh Medical Center UPMC Hillman Cancer Center | 15232 | Pittsburgh | Pennsylvania |
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