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)
NCT05064059Phase 3Completed
- Lead sponsor
- Merck Sharp & Dohme LLC (Industry)
- Enrollment
- 441 (actual)
- Start date
- 10 Nov 2021
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 21 Feb 2025
- Last update posted
- 26 May 2026
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 33 months)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT05064059 (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
Overall Survival (OS)
- Time frame
- Up to approximately 33 months
- Measure
- Median
- Unit
- Months
Favezelimab/Pembrolizumab vs Standard of Care (Regorafenib or TAS-102)Superiority
- Estimate
- 0.98Hazard Ratio (HR)
- 95% CI, two-sided
- 0.80 to 1.20
- p-value
- 0.4183
- Method
- Log Rank
Serious adverse events
Time frame: Up to approximately 38 months
| Group | Affected | At risk |
|---|---|---|
| Favezelimab/Pembrolizumab | 75 | 221 |
| Standard of Care (Regorafenib or TAS-102) | 56 | 210 |
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
1 on PubMedNext-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy.
Journal of immunology research · 2026
PubMed 41811823 (opens in a new tab)DOI 10.1155/jimr/7864229 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT05064059 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
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.