Trial details
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
To find out more about this trial and your cancer treatment options, please speak with your doctor.
Trial short name: ADJ V94
Official title: 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
Principal Investigator: Dr. Rossanna Pezo
Cancer type: Melanoma
Cancer location: Melanoma
Disease stage: Early Cancer
Trial phase: Phase 3
Intervention: Biological: V940, Biological: Pembrolizumab, Other: Placebo
Registration #:
NCT05933577 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.
Inclusion Criteria: 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 that rendered the participant disease-free 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) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: • Has ocular or mucosal melanoma • Has cancer that has spread to other parts of the body and cannot be removed with surgery • 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
