drugset / Trial / 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
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this China extension study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in adult Chinese participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.
Timeline
- Start
- 2022-06-14
- Primary completion
- 2024-08-15
- Completion
- 2025-02-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Favezelimab | Unknown | 800 mg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Comparator | Regorafenib | Small molecule | 160 mg | Oral |
| Comparator | TAS-102 | Small molecule | 35 mg/m2 | Oral |