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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06632951 | Study to Evaluate Adverse Events and Change in Disease Activity When Intravenously (IV) Infused Livmoniplimab is Used in Combination With IV Infused Budigalimab in Adult Participants With Urothelial Carcinoma (UC) | PHASE2 | ACTIVE NOT_RECRUITING | 150 | — | — | Jan 20, 2025 | Aug 1, 2028 | Aug 11, 2025 | 37 | United States, Canada +6 |
OS is defined as the time measured from randomization until death from any cause.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Livmoniplimab (Dose A) + Budigalimab | EXPERIMENTAL | Participants will receive livmoniplimab (dose A) in combination with budigalimab, as part of the approximately 3.5 years study duration. |
| Arm 2: Livmoniplimab (Dose B) + Budigalimab | EXPERIMENTAL | Participants will receive livmoniplimab (dose B) in combination with budigalimab, as part of the approximately 3.5 years study duration. |
| Arm 3: Docetaxel, Paclitaxel, or Gemcitabine | EXPERIMENTAL | Participants will receive docetaxel, paclitaxel, or gemcitabine, investigator's choice, as part of the approximately 3.5 years study duration. |
| Name | Type | Description |
|---|---|---|
| Livmoniplimab | DRUG | Intravenous (IV) Infusion |
| Budigalimab | DRUG | IV Infusion |
| Docetaxel | DRUG | IV Infusion |
| Paclitaxel | DRUG | IV Injection |
| Gemcitabine | DRUG | IV Infusion |
Inclusion Criteria: * Participant has histologically or cytologically confirmed urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Mixed histologic types are allowed if urothelial (transitional cell) is the predominant histology. * Participant has radiologically d...