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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04658862 | A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder | PHASE3 | ACTIVE NOT_RECRUITING | 518 | — | — | Dec 7, 2020 | Dec 31, 2028 | Jun 5, 2026 | 290 | United States, Argentina +23 |
Time from randomization to the first BI-EFS event includes histologically proven presence of muscle-invasive bladder cancer (MIBC), clinical evidence of nodal or metastatic disease (as assessed by RECIST 1.1 criteria), radical cystectomy (RC), or death due to any cause.
| Arm | Type | Description |
|---|---|---|
| TAR-200 + Cetrelimab | EXPERIMENTAL | Participants will receive intravesical TAR-200 every 3 weeks (21 days indwelling) for first 18 weeks and thereafter from Week 24 every 12 weeks through study Year 3 in combination with intravenous (IV) Cetrelimab. |
| Chemotherapy (cisplatin or gemcitabine) + Radiation Therapy | ACTIVE_COMPARATOR | Participants will receive chemotherapy based on investigator's choice from either cisplatin intravenously once weekly for 4 to 6 treatment weeks or gemcitabine intravenously twice weekly for 4 to 6 treatment weeks as Standard of Care (SOC) along with radiation therapy from either conventional radiotherapy (64 Gray \[Gy\], bladder only) for up to 6.5 treatment weeks or hypo-fractionated radiotherapy (55 Gy, bladder only) for up to 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Cetrelimab | BIOLOGICAL | Participants will receive intravenous Cetrelimab. |
| TAR-200 | DRUG | Participants will receive intravesical TAR-200. |
| Cisplatin | DRUG | Participants will receive cisplatin intravenously. |
| Gemcitabine | DRUG | Participants will receive gemcitabine intravenously. |
| Conventional radiation therapy | RADIATION | Participants will receive conventional radiation therapy for bladder (64 gy). |
| Hypo-fractioned radiation therapy | RADIATION | Participants will receive hypo-fractioned radiation therapy for bladder (55 gy). |
Inclusion Criteria: * Ineligible for or have elected not to undergo radical cystectomy * All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade less than (\<) 2 prior to randomiz...