Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MK-4280A
Favezelimab/Pembrolizumab · 1 trial · 2 indications
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...
Favezelimab/pembrolizumab is being studied in metastatic urothelial carcinoma, a form of bladder cancer that has spread. It is an investigational coformulation being evaluated in the first-line treatment setting for this indication. It is not approved for any use and remains in clinical development.
Favezelimab/pembrolizumab targets LAG3, also known as lymphocyte activation gene 3. Favezelimab is a LAG3 inhibitor designed to block this immune checkpoint, while pembrolizumab targets PD-1. The coformulation combines both antibodies to potentially enhance antitumor immune responses.
Favezelimab/pembrolizumab is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program evaluating this coformulation in metastatic urothelial carcinoma.
Favezelimab/pembrolizumab is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any regulatory authority for any indication. The ongoing trial is evaluating its safety and efficacy in metastatic urothelial carcinoma.
Favezelimab/pembrolizumab is being studied in the Phase 1 trial NCT05845814, titled KEYMAKER-U04. This active, not recruiting study is evaluating pembrolizumab plus enfortumab vedotin with or without investigational agents, including favezelimab/pembrolizumab, in first-line metastatic urothelial carcinoma. It has an estimated enrollment of 390 participants across multiple countries.
Yes, favezelimab/pembrolizumab is also known as MK-4280A. Other names include coformulation favezelimab/pembrolizumab and coformulated favezelimab/pembrolizumab. These terms refer to the same investigational coformulation developed by Merck.