Sponsor: Merck
Sponsor Study ID: V940-001
Study Title: Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants with High-Risk Stage II-IV Melanoma
CTO #: 103866
NCT Number: NCT05933577
Phase: III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Melanoma, Skin
Study Objectives: To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to RFS. To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DMFS. To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to OS. To evaluate the safety and tolerability of V940 plus pembrolizumab. To evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab with respect to mean change from baseline in global health status/QoL, physical functioning, and role functioning using the EORTC QLQ-C30.