At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed diagnosis of IR-NMIBC (within 90 days) with Ta LG/G1 (primary or recurrent), Ta LG/G2, or ≥1 risk factors (multiple Ta LG tumors, solitary LG ≥3cm, early recurrence <1 year, frequent recurrence >1/year, or recurrence after prior adjuvant intravesical treatment)
- ✓Susceptible FGFR mutation or fusion by urine or tumor tissue testing (central or local)
- ✓Willing to undergo all study procedures including multiple cystoscopies and TURBT, and receive assigned treatment including intravesical chemotherapy if randomized
- ✓Visible papillary disease fully resected prior to randomization with absence of disease documented at Screening cystoscopy
- ✕Known allergies, hypersensitivity, or intolerance to erdafitinib excipients, TAR-210 materials, urinary catheter materials, MMC, gemcitabine, or chemically related drugs
- ✕Bladder or urethral anatomic features (e.g., urethral stricture) preventing safe insertion/use of TAR-210 or passage of urethral catheter
- ✕Polyuria with 24-hour urine volumes >4000 mL
- ✕Current indwelling urinary catheters (intermittent catheterization acceptable)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations
In Brief
A Phase 3 clinical trial evaluating TAR-210, Gemcitabine, and 1 other intervention for Non-Muscle Invasive Bladder Neoplasms. Currently recruiting, targeting 641 participants across 193 sites in 20 countries.
Detailed Summary
The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.
Study Details
Timeline
Arms & Interventions
Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year.
Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.
Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year.
Participants in substudy Group B will receive intravesical MMC once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.
Interventions
TAR-210 will be administered intravesically.
Gemcitabine will be administered intravesically.
MMC will be administered intravesically.