NCT05665595

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, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,594 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

With Amendment 4, participants will discontinue treatment with pembrolizumab/vibostolimab. The protocol-specified futility analysis of the primary outcome measure was completed with a data cut-off of 06-Mar-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure. Per protocol, 192 participants enrolled after the primary completion date and will be analyzed in the End of Trial analysis.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab/Vibostolimab	Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 17 administrations
BIOLOGICAL	Pembrolizumab	Pembrolizumab 25 mg/mL administered as IV infusion for up to 17 administrations

Timeline

• Start date: 2023-01-19
• Primary completion: 2024-03-06
• Completion: 2025-09-26
• First posted: 2022-12-27
• Last updated: 2025-10-15
• Results posted: 2025-04-06

Locations

205 sites across 26 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, India, Ireland, Israel, Italy, Japan, New Zealand, Poland, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study