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)
CompletedPhase 3Results postedLast updated 15 October 2025
What this trial tests
Phase 3 trial testing Pembrolizumab/Vibostolimab in Melanoma in 1,594 participants. Completed in 26 September 2025.
12 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Recurrence-Free Survival (RFS)Primary· Up to approximately 13 months
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.
Group
Value
95% CI
Pembrolizumab/Vibostolimab
NA
NA – NA
Pembrolizumab
NA
NA – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to approximately 13 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06395090 — A Study of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hemat
· Phase 1, PHASE2
· withdrawn
NCT05226598 — Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus
· Phase 3
· completed
NCT04895722 — Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatel
· Phase 2
· active not recruiting
NCT04738487 — Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell De
· Phase 3
· completed
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Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 15 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05665595.