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)

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.

Timeline

Start

2023-01-19

Primary completion

2024-03-06

Completion

2025-09-26

Publications

• Dummer R, Guo J, Luke JJ, Carlino MS, Schadendorf D, Khattak MA, Hauschild A, Ascierto PA, Chen Y, Shin SJ, Rutkowski P, Luo Z, Chen J, Rivalland G, Coetzee C, Ribas A, Mujika K, Markel G, Villarroel RU, Dizdar O, Caglevic C, Grebennik D, Donovan K, Krepler C, Long GV. Vibostolimab coformulated with pembrolizumab versus pembrolizumab alone as adjuvant therapy for high-risk stage IIB-IV melanoma (KEYVIBE-010): a randomised, double-blind, phase 3 study. Lancet Oncol. 2026 Mar;27(3):327-339. doi: 10.1016/S1470-2045(25)00709-0. Epub 2026 Feb 13.
• Shapira-Frommer R, Niu J, Perets R, Peters S, Shouse G, Lugowska I, Garassino MC, Sands J, Keenan T, Zhao B, Healy J, Ahn MJ. The KEYVIBE program: vibostolimab and pembrolizumab for the treatment of advanced malignancies. Future Oncol. 2024;20(27):1983-1991. doi: 10.1080/14796694.2024.2343272. Epub 2024 Sep 4.

Drugs

Indications