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 (Jun 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
Treatments studied
Chemotherapy
Other
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 →Frequently asked questions
Is NCT06919965 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received BCG.
Does this trial require FGFR?
Yes, FGFR susceptible mutation is a required biomarker for enrollment.
Does this trial require FGFR?
Yes, FGFR fusion is a required biomarker for enrollment.
What disease stage is eligible?
Stage HIGH-GRADE TA or ANY T1 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages