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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 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 441 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05064059
The ClinicalTrials.gov registry entry for NCT05064059 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 441 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which TAS-102 is the first listed.
NCT05064059 reports 0 study locations.
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.
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