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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT05933577

Run by

Merck Sharp & Dohme LLC

People needed

1089

Starts

2023-07-19

Expected to finish

2030-09-26

Last updated by the study team

2025-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918) — Los Angeles, California, United States
• UCSF Medical Center at Mission Bay ( Site 1929) — San Francisco, California, United States
• Yale-New Haven Hospital-Yale Cancer Center ( Site 1933) — New Haven, Connecticut, United States
• Orlando Health Cancer Institute ( Site 1937) — Orlando, Florida, United States
• Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945) — Tampa, Florida, United States
• Winship Cancer Institute of Emory University ( Site 1940) — Atlanta, Georgia, United States
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950) — Marietta, Georgia, United States
• University of Iowa-Holden Comprehensive Cancer Center ( Site 1935) — Iowa City, Iowa, United States
• Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912) — Baltimore, Maryland, United States
• Massachusetts General Hospital ( Site 1927) — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center ( Site 1957) — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute ( Site 1956) — Boston, Massachusetts, United States
• University of Michigan ( Site 1915) — Ann Arbor, Michigan, United States
• Cancer and Hematology Centers of Western Michigan ( Site 1932) — Grand Rapids, Michigan, United States
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944) — Hackensack, New Jersey, United States
• Atlantic Health System ( Site 1925) — Morristown, New Jersey, United States
• Valley Health Systems - Ridgewood Campus ( Site 1947) — Ridgewood, New Jersey, United States
• Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958) — Mineola, New York, United States
• NYU Langone Health-Perlmutter Cancer Center ( Site 1917) — New York, New York, United States
• Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 1908) — New York, New York, United States
• Memorial Sloan Kettering Cancer Center ( Site 1914) — New York, New York, United States
• University of North Carolina Medical Center-Lineberger Comprehensive Cancer Center ( Site 1949) — Chapel Hill, North Carolina, United States
• Duke Cancer Institute ( Site 1911) — Durham, North Carolina, United States
• Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 1905) — Philadelphia, Pennsylvania, United States
• Highlands Oncology Group ( Site 1943) — Springdale, Arkansas, United States

Full record on ClinicalTrials.gov

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