The primary objective of this study is to compare pembrolizumab/vibostolimab with pembrolizumab in terms of recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab in terms of investigator-assessed recurrence-free survival in participants with high-risk, resected stage IIB, IIC, III and IV melanoma.
Aim of the study
In this study, MK-7684A is being investigated in adults after surgical removal of their melanoma. MK-7684A is an experimental treatment and is a combination of two drugs: Vibostolimab and Pembrolizumab. The study is being conducted to compare MK-7684A with pembrolizumab alone. The study will therefore test the safety of MK-7684A in comparison with pembrolizumab. It will also assess how well MK-7684A works compared to pembrolizumab and whether participants who receive MK-7684A live longer and have a better quality of life than those who receive pembrolizumab.
Who can take part?
Patients with stage II-IV high-risk melanoma
Procedure
This study comprises two groups. If you take part, you will be randomly assigned to one of these two groups. The chance of being assigned to group 1 is the same as the chance of being assigned to group 2. Which medication you receive depends on which group you are assigned to. Group 1 receives MK-7684A, group 2 receives pembrolizumab. All study drugs are administered every three weeks via a needle into the arm (intravenous infusion). How long you will be in the study depends on your state of health and how well you tolerate the study medication. As long as your cancer does not worsen and you tolerate the study medication, you will be in the treatment phase for about a year.
Compensation
None
Original study name
A randomized, double-blind, active-controlled phase III clinical trial of adjuvant MK-7684A (vibostolimab plus pembrolizumab) versus adjuvant pembrolizumab in participants with stage II-IV high-risk melanoma
BASEC number
2022-02032
Financial support from
MSD / Merck Sharp & Dohme AG