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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05600309 | A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)-China Extension Study | PHASE3 | COMPLETED | 94 | — | — | Jun 14, 2022 | Feb 21, 2025 | Nov 26, 2025 | 24 | China |
| NCT05064059 | A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007) | PHASE3 | COMPLETED | 441 | — | — | Nov 10, 2021 | Feb 21, 2025 | May 26, 2026 | 152 | United States, Australia +19 |
OS was defined as the time from randomization to death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Favezelimab/Pembrolizumab | EXPERIMENTAL | Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions. |
| Standard of Care (Regorafenib or TAS-102) | ACTIVE_COMPARATOR | At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle or 35 mg/m\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| favezelimab/pembrolizumab | BIOLOGICAL | Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion |
| regorafenib | DRUG | Oral |
| TAS-102 | DRUG | Oral |
Inclusion Criteria: * Has a histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable. * Has measurable disease per RECIST 1.1 as assessed by the local site investigator. * Has been previously treated for the disease and radiographically progressed on or after or could ...