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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05600309
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • favezelimab/pembrolizumab — BIOLOGICAL
    Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
  • regorafenib — DRUG
    Oral
  • TAS-102 — DRUG
    Oral

Study Details

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.

Key Dates

Start date
Jun 14, 2022
Status verified
Nov 2025
Primary completion
Aug 15, 2024
Completion
Feb 21, 2025

Study Design

Enrollment
94 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Favezelimab/Pembrolizumab
    Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.
  • Active Comparator: Standard of Care (Regorafenib or TAS-102)
    At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle or 35 mg/m\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 26 months ]

Related coverage on Hipa.ai

Related Studies