NCT05933577

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,089 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Type	Name	Description
BIOLOGICAL	Intismeran autogene	IM injection
BIOLOGICAL	Pembrolizumab	IV infusion
OTHER	Placebo	IM injection

Timeline

• Start date: 2023-07-19
• Primary completion: 2029-10-26
• Completion: 2030-09-26
• First posted: 2023-07-06
• Last updated: 2025-09-24

Locations

165 sites across 26 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Germany, Greece, Israel, Italy, Japan, New Zealand, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study