NCT05933577Recruiting

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

Name: Clinical Trial NCT05933577
Creator: Merck Sharp & Dohme LLC
Keywords: Melanoma, V940, Phase 3, biological, clinical trial, Australia

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

Merck Sharp & Dohme LLCPhase 3ClinicalTrials.govbiological

Verified

Study focus

Disease/Condition: Melanoma
Drug/Device/Intervention: V940
Study type: Interventional
Intervention type: biological

Sponsor & location

Primary sponsor: Merck Sharp & Dohme LLC
Location: Wollstonecraft,Nedlands, Australia

Timeline & enrollment

Phase: Phase 3
Start date: Jul 19, 2023
End date: Sep 26, 2030
Enrollment: 1089 participants

Primary outcome

Recurrence-Free Survival (RFS)

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.

ICD-10 classifications

Malignant melanoma of skinMelanoma in situ, unspecifiedMelanoma in situMelanoma and other malignant neoplasms of skinMalignant neoplasm: Malignant melanoma of skin, unspecified

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05933577
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05933577 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme LLC and is currently Recruiting. The study focuses on Melanoma. Target enrollment is 1089 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.