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NCT05665595 · ClinicalTrials.gov registry record · Phase 3
A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,594
- Enrollment target
NCT05665595: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT05665595 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,594 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (106% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05665595, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,594 participants
- Enrollment target
Study Summary
The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.
Primary Outcome
RFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) as assessed by the investigator, or death due to any cause, whichever occurs first. The RFS as assessed by the investigator is presented for all randomized participants. Protocol pre-specified final analysis for this outcome measure was conducted with the primary completion data cut-off.
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Pembrolizumab/Vibostolimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,594 participants |
| Start Date | 2023-01-19 |
| Est. Completion | 2025-09-26 |
| Phase | Phase 3 |
What the finished NCT05665595 record still lists
NCT05665595 is an interventional study that assigns participants to a tested intervention. Its 1,594 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (106% higher).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05665595 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05665595 about?
NCT05665595 is a clinical study titled "A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)". The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with ...
What is the current status of trial NCT05665595?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,594 participants. The study started on 2023-01-19. Estimated completion is 2025-09-26.
What interventions are being tested in trial NCT05665595?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Pembrolizumab/Vibostolimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05665595?
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 NCT05665595's enrollment target sits among peer trials
1,594 146th of 2000 higher than 1,854 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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