drugset / Trial / 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)

NCT05064059

Phase 3 Completed 441 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-11-10
Primary completion
2024-08-15
Completion
2025-02-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Regorafenib Small molecule 160 mg Oral
Comparator TAS-102 Small molecule 35 mg/m2 Oral
Subject favezelimab/pembrolizumab Unknown Intravenous

Indications