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

Status
Active
Cancer Type
Melanoma
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05933577
Protocol IDs
V940-001 (primary)
NCI-2023-05647
2023-503652-27-00
V940-001
Study Sponsor
Merck Sharp & Dohme LLC

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.

Eligibility

  1. Inclusion Criteria: 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) Exclusion Criteria: 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

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.