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Oncology & Cancer Care
Clinical trials19 open Second opinion
Active, closed to enrolmentPhase 3NCT05933577

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

Intismeran autogene (V940) is a personalised mRNA cancer vaccine made from each patient's own tumor mutations. This study tests it together with pembrolizumab after surgery in people with high-risk melanoma to see if it lowers the chance of the cancer returning.

SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Started2023-07-19
Primary completion2029-10-26
Planned enrolment1089
Sites1 Acıbadem · 164 other

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)

What this study is about

The purpose of this study is to learn if intismeran autogene 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 intismeran autogene with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.

Conditions
  • Melanoma
Interventions
  • Intismeran autogene
  • Pembrolizumab
  • Placebo
Primary outcome measures
  • Recurrence-Free Survival (RFS) — Up to approximately 74 months
Who can take part
SexAllAge18 Years to no upper limitHealthy volunteersNo
Inclusion
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
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

Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.

Acıbadem study sites
  • Acıbadem Atakent Hastanesi-Medical Oncology ( Site 3008), Istanbul

Also running at 164 other sites in 26 countries.

Source: ClinicalTrials.gov NCT05933577 · last updated 2025-09-24 · View registry record ↗