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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

NCT05600309Phase 3Completed

Lead sponsor
Merck Sharp & Dohme LLC (Industry)
Enrollment
94 (actual)
Start date
14 Jun 2022
Primary completion
15 Aug 2024 (actual)
Study completion
21 Feb 2025
Last update posted
26 Nov 2025

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
None
Arms
2

Interventions

  • favezelimab/pembrolizumab Biological
  • regorafenib Drug
  • TAS-102 Drug

Conditions and primary outcome

  • Colorectal Cancer

Primary outcome

Overall Survival (OS) (Up to approximately 26 months)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT05600309 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Overall Survival (OS)

    Time frame
    Up to approximately 26 months
    Measure
    Median
    Unit
    Months

    • Favezelimab/Pembrolizumab vs Standard of Care (Regorafenib or TAS-102)Other

      Estimate
      0.94Hazard Ratio (HR)
      95% CI, two-sided
      0.59 to 1.50
      p-value
      0.3914
      Method
      Log Rank

Serious adverse events

Time frame: Up to approximately 30 months

Participants with serious adverse events per group for NCT05600309, as posted
GroupAffectedAt risk
Favezelimab/Pembrolizumab1249
Standard of Care (Regorafenib or TAS-102)1344

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT05600309.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.