drugset / Trial / NCT03897881

An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)

NCT03897881

Phase 2 Active not recruiting 267 enrolled ModernaTX, Inc. Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in participants with complete resection of cutaneous melanoma and a high risk of recurrence.

Timeline

Start
2019-07-18
Primary completion
2032-11-30
Completion
2032-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Intismeran autogene Messenger RNA (mRNA) 1 mg Intramuscular
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications