Study

Overview

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 (INTerpath-001)

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.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

1089

Study Start Date:

July 2023

Estimated Study Completion Date:

September 2030

Estimated Primary Completion Date:

October 2029

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

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