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)

Brief description of study

This research study is for people who are 12 years of age or older and weigh at least 40 kg, and who have had surgery to remove high-risk melanoma (a type of skin cancer). The study aims to compare the effectiveness in treating high-risk melanoma with two treatments, MK-7684A and pembrolizumab, two immunotherapies that work by telling the immune system to attack cancer cells.

The study will involve participants who have not received any previous treatments for their melanoma beyond surgery. Participants will be randomly assigned to receive either MK-7684A or pembrolizumab, and the study will be double-blind, meaning that neither the participants nor the doctors will know which treatment is being administered. Participants will be followed for up to 17 treatment cycles or until they meet the criteria for stopping treatment. Participants will also have imaging tests as needed and will be monitored for disease recurrence and survival after the study ends. The study will be conducted at multiple centers and participants will be stratified based on their risk level and geographic region.


Clinical Study Identifier: s22-01400
ClinicalTrials.gov Identifier: NCT05665595
Principal Investigator: Janice Mehnert.


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