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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05845814 | A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04) | PHASE1 | ACTIVE NOT_RECRUITING | 390 | — | — | Jun 23, 2023 | May 31, 2027 | Sep 10, 2025 | 47 | United States, Australia +10 |
ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). ORR will be reported for participants in Part 1.
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants experiencing an AE in Part 1 will be reported.
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants who discontinue study interventions due to an AE in Part 1 will be reported.
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE 5.0). The number of participants who experience a DLT in Part 1 will be reported.
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PFS will be reported for participants in Part 2.
| Arm | Type | Description |
|---|---|---|
| Arm A: Coformulated favezelimab/pembrolizumab plus EV | EXPERIMENTAL | Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) as an intravenous (IV) infusion on Day 1 of every 3-week cycle for up to \~2 years (35 cycles) and EV at 1.25 mg/kg, administered as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision. |
| Arm B: Coformulated vibostolimab/pembrolizumab plus EV | EXPERIMENTAL | Participants will receive coformulated vibostolimab/pembrolizumab (200 mg/200 mg) as an IV infusion on Day 1 of every 3-week cycle, for up to \~2 years (35 cycles) and EV at 1.25 mg/kg, administered as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision. |
| Arm C: Pembrolizumab plus EV | ACTIVE_COMPARATOR | Participants will receive 200 mg pembrolizumab as an IV infusion on Day 1 of every 3-week cycle for up to \~2 years (35 cycles) and EV at 1.25 mg/kg, administered as an IV infusion on Days 1 and 8 of every 3-week cycle, until disease progression, intolerable toxicity, or investigator decision. |
| Name | Type | Description |
|---|---|---|
| Coformulated favezelimab/pembrolizumab | BIOLOGICAL | Coformulated favezelimab/pembrolizumab (800 mg/200 mg) IV infusion |
| Coformulated vibostolimab/pembrolizumab | BIOLOGICAL | Coformulated vibostolimab/pembrolizumab (200 mg/200 mg) IV infusion |
| EV | COMBINATION_PRODUCT | 1.25 mg/kg IV infusion |
| Pembrolizumab | BIOLOGICAL | 200 mg IV infusion |
Inclusion Criteria: * Must have histologically documented, locally advanced/metastatic urothelial carcinoma (la/mUC). * Participants with mixed histology are eligible provided the urothelial component is ≥50% (and \<10% plasmacytoid component) * Participants whose tumors contain any neuroendoc...