CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 441 enrolled
Drug / intervention
favezelimab/pembrolizumab +2 morebiological
Likely dose
favezelimab/pembrolizumab 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05064059
NCT05064059Phase 3Completed

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)

Merck Sharp & Dohme LLC·interventional·Posted Oct 1, 2021·Updated May 26, 2026

In Brief

A Phase 3 clinical trial evaluating favezelimab/pembrolizumab, regorafenib, and 1 other intervention for Colorectal Cancer. Completed, enrolled 441 participants across 152 sites in 21 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, Chile, China, Czechia, France, Germany, Israel, Italy, Japan, Malaysia, Norway, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedOct 1, 2021
Enrollment StartNov 10, 2021
Primary CompletionAug 15, 2024
Study CompletionFeb 21, 2025
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 4.8 years ago

Interventions

favezelimab/pembrolizumabbiological

Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion

regorafenibdrug

Oral

TAS-102drug

Oral