A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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

Join this Trial

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