Trial results for the Phase 3 KEYVIBE-010 study (NCT05665595) investigating pembrolizumab/vibostolimab versus pembrolizumab alone for resected high-risk melanoma were posted on ClinicalTrials.gov on 2025-04-06. The study's primary analysis for recurrence-free survival (RFS) showed a hazard ratio of 1.25 (95% CI: 0.87 to 1.8) for the combination therapy compared to pembrolizumab.
Background
The KEYVIBE-010 study, officially 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)," aimed to evaluate the efficacy of the combination therapy in an adjuvant setting. The primary hypothesis was that pembrolizumab/vibostolimab would be superior to pembrolizumab alone with respect to recurrence-free survival (RFS) in participants with high-risk resected Stage IIB, IIC, III, and IV melanoma.
Trial design
The KEYVIBE-010 study (NCT05665595) was a Phase 3, randomized, active-controlled trial that enrolled 1594 participants. The study investigated pembrolizumab/vibostolimab compared to pembrolizumab alone in participants with melanoma, specifically high-risk resected Stage IIB, IIC, III, and IV melanoma. The primary outcome measure was recurrence-free survival (RFS) as assessed by the investigator.
Key results
For the primary outcome of Recurrence-Free Survival (RFS), the key analysis reported a Hazard Ratio (HR) of 1.25. The 95% Confidence Interval for this HR was from 0.87 to 1.8. No median RFS values were reported for either the Pembrolizumab/Vibostolimab group or the Pembrolizumab group.
What this means
The results of the KEYVIBE-010 trial indicate that the combination of pembrolizumab/vibostolimab did not demonstrate superiority over pembrolizumab alone for recurrence-free survival in participants with high-risk resected melanoma. The hazard ratio of 1.25, with a 95% Confidence Interval that includes 1.0, suggests that the primary hypothesis of superiority for the combination therapy was not met. The point estimate of the hazard ratio also suggests a trend towards worse RFS with the combination, although this finding was not statistically significant.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05665595, 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)," were posted on 2025-04-06 on clinicaltrials.gov.