Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

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)

Keywords

Melanoma, Pembrolizumab, V940 + Pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

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)

You CAN'T join if...

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

Locations

  • UCSF Medical Center at Mission Bay ( Site 1929) accepting new patients
    San Francisco California 94158 United States
  • Texas Oncology - Dallas (Sammons) ( Site 1902) accepting new patients
    Dallas Texas 75246 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trials Information Plain Language Summary
ID
NCT05933577
Phase
Phase 3 Skin Cancer/Melanoma Research Study
Study Type
Interventional
Participants
Expecting 1089 study participants
Last Updated