At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic, unresectable colorectal adenocarcinoma
- ✓Measurable disease per RECIST 1.1
- ✓Prior treatment with radiographic progression or intolerance to standard therapy
- ✓Archival (≤5 years) or newly obtained tumor tissue sample for testing
- ✕Deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) tumor status
- ✕Active CNS metastases, carcinomatous meningitis, or leptomeningeal disease
- ✕History of acute or chronic pancreatitis
- ✕Neuromuscular disorders with elevated creatine kinase
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (KEYFORM-007)
In Brief
A Phase 3 clinical trial evaluating favezelimab/pembrolizumab, regorafenib, and 1 other intervention for Colorectal Cancer. Completed, enrolled 94 participants across 24 sites.
Detailed 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.
Study Details
Timeline
Interventions
Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
Oral
Oral