Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06919965 | A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer | PHASE3 | RECRUITING | 220 | — | — | Sep 10, 2025 | Mar 16, 2032 | Jun 5, 2026 | 109 | United States, Argentina +13 |
| NCT06319820 | A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer | PHASE3 | RECRUITING | 641 | — | — | Apr 18, 2024 | Dec 31, 2032 | Jun 5, 2026 | 193 | United States, Argentina +18 |
DFS is measured as the time from randomization to the date of the first recurrence of HR-NMIBC (high-grade Ta, any T1 or carcinoma in situ \[CIS\]), progression, or death due to any cause, whichever occurs first.
DFS is measured as the time from randomization to the date of the first documented recurrence of Ta non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Group A: TAR-210 | EXPERIMENTAL | Participants in Group A will have TAR-210 inserted in the bladder on Day 1. TAR-210 will be inserted over a treatment duration of approximately 2 years. |
| Group B: Mitomycin C (MMC) or Gemcitabine | ACTIVE_COMPARATOR | 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 maintenance dosing once monthly for up to 1 year. An optional second year of additional maintenance can be added at the investigator's discretion. |
| Main Study: Group A: TAR-210 | EXPERIMENTAL | 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. |
| Main Study: Group B: MMC or Gemcitabine | ACTIVE_COMPARATOR | 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. |
| Substudy: Group A: TAR-210 | EXPERIMENTAL | 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. |
| Substudy: Group B: MMC | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| TAR-210 | DRUG | TAR-210 will be administered intravesically. |
| Mitomycin C | DRUG | MMC will be administered intravesically. |
| Gemcitabine | DRUG | Gemcitabine will be administered intravesically. |
| MMC | DRUG | MMC will be administered intravesically. |
Inclusion criteria: * Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded * H...