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Phase III

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)

  • Study HIC#:2000035702
  • Last Updated:04/18/2024

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.

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    Eligibility 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

    Principal Investigator

    For more information about this study, including how to volunteer, contact: