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)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 441 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in 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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	favezelimab/pembrolizumab	Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
DRUG	regorafenib	Oral
DRUG	TAS-102	Oral

Timeline

• Start date: 2021-11-10
• Primary completion: 2024-08-15
• Completion: 2025-02-21
• First posted: 2021-10-01
• Last updated: 2025-09-17
• Results posted: 2025-09-17

Locations

152 sites across 21 countries: United States, Australia, Canada, Chile, China, Czechia, France, Germany, Israel, Italy, Japan, Malaysia, Norway, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study