drugset / Trial / NCT05933577

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

NCT05933577

Phase 3 Active not recruiting 1089 enrolled Merck Sharp & Dohme LLC ModernaTX, Inc. · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2023-07-19
Primary completion
2029-10-26
Completion
2030-09-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Intismeran autogene Messenger RNA (mRNA) Intramuscular
Subject Pembrolizumab Monoclonal antibody Intravenous

Indications