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NCT05064059 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 441
- Enrollment target
NCT05064059: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT05064059 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 441 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05064059, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 441 participants
- Enrollment target
Study 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.
Primary Outcome
OS was defined as the time from randomization to death due to any cause.
Interventions
- DRUG TAS-102
- DRUG regorafenib
- BIOLOGICAL favezelimab/pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 441 participants |
| Start Date | 2021-11-10 |
| Est. Completion | 2025-02-21 |
| Phase | Phase 3 |
What the finished NCT05064059 record still lists
NCT05064059 is an interventional study that assigns participants to a tested intervention. The registered 441 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which TAS-102 is the first listed.
NCT05064059 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05064059 about?
NCT05064059 is a clinical study titled "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)". 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). Th...
What is the current status of trial NCT05064059?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 441 participants. The study started on 2021-11-10. Estimated completion is 2025-02-21.
What interventions are being tested in trial NCT05064059?
The interventions under investigation include: TAS-102 (DRUG), regorafenib (DRUG), favezelimab/pembrolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05064059?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05064059's enrollment target sits among peer trials
441 867th of 2000 higher than 1,134 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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