Groupe d'Etude en Oncologie du Quebec

Titre	A 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
Protocole ID	V940-001
ClinicalTrials.gov ID	NCT05933577
Type(s) de cancer	Mélanome
Phase	Phase III
Type étude	Clinique
Médicament	V940 + pembrolizumab versus placebo + pembrolizumab
Institution	CHU DE QUEBEC – UNIVERSITE LAVAL HOPITAL DE L'ENFANT-JESUS 1401 18e Rue, Québec, QC, G1J 1Z4
Ville	Québec
Investigateur(trice) principal(e)	Dr Joël Claveau
Coordonnateur(trice)	Mélanie Bradley 418-525-4444 poste 12950
Statut	Actif en recrutement
Date d'activation	13-10-2023
Critètes d'éligibilité	The main inclusion criteria include but are not limited to the following: Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma Has not received any prior systemic therapy for their melanoma beyond surgical resection No more than 13 weeks have passed between final surgical resection and the first dose of pembrolizumab Is disease free at the time of providing documented consent for the study Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
Critètes d'exclusion	The main exclusion criteria include but are not limited to the following: Has ocular or mucosal melanoma Has past or current cancer that has spread to other parts of the body Has heart failure within the past 6 months Has received prior cancer therapy or another cancer vaccine Has another known cancer that that has spread to other parts of the body or has required treatment within the past 3 years Has severe reaction to study medications or any of their substance used to prepare a drug Have not recovered from major surgery or have ongoing surgical complications

Groupe d'étude en oncologie du Québec