OncoMatch/Clinical Trials/NCT06919965
A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
Is NCT06919965 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including TAR-210 and Mitomycin C for non-muscle invasive bladder neoplasms.
Treatment: TAR-210 · Mitomycin C · Gemcitabine — The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: FGFR susceptible mutation
Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determined by central or local testing
Required: FGFR fusion
Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determined by central or local testing
Disease stage
Required: Stage HIGH-GRADE TA, ANY T1
Excluded: Stage CIS, M+
Grade: high-grade
papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is [i.e.], T2, T3, T4, N+, and/or M+)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BCG
Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population); had adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or been unable to complete an induction course of BCG with at least 5 doses due to grade >= 2 toxicity requiring BCG discontinuation (BCG intolerant population)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Colorado Clinical Research · Lakewood, Colorado
- Georgia Urology · Atlanta, Georgia
- Associated Urological Specialists · Chicago Ridge, Illinois
- Urology of Indiana · Carmel, Indiana
- Greater Boston Urology · Plymouth, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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