Clinical Trial 23114

• Overview

  Study Title:

  V940-001- 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)

  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.

  Objective:

  Primary Objective To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to RFS. Hypothesis (H1): V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to RFS as assessed by the investigator. Secondary Objectives To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DMFS. Hypothesis (H2): V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DMFS as assessed by the investigator.

• Treatments

  Therapies:

  Immunotherapy; Therapy (NOS); Vaccine

  Medications:

  Pembrolizumab (Keytruda); Placebo (); mRNA-4157 ()

• Inclusion Criteria

  Inclusion Criteria:
  • 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

  Exclusion Criteria:
  • 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

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