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Clinical Trials in the UK / NCT05933577
Active, not recruiting Phase 3

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

NCT05933577 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2023-07-19
Last updated
2025-09-24

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

Intismeran autogenePembrolizumabPlacebo

Intismeran autogene: IM injection

Pembrolizumab: IV infusion

Placebo: IM injection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (165)

FacilityCityRegionStatus
Highlands Oncology Group ( Site 1943) Springdale Arkansas
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918) Los Angeles California
UCSF Medical Center at Mission Bay ( Site 1929) San Francisco California
Yale-New Haven Hospital-Yale Cancer Center ( Site 1933) New Haven Connecticut
Orlando Health Cancer Institute ( Site 1937) Orlando Florida
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945) Tampa Florida
Winship Cancer Institute of Emory University ( Site 1940) Atlanta Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950) Marietta Georgia
University of Iowa-Holden Comprehensive Cancer Center ( Site 1935) Iowa City Iowa
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912) Baltimore Maryland
Massachusetts General Hospital ( Site 1927) Boston Massachusetts
Beth Israel Deaconess Medical Center ( Site 1957) Boston Massachusetts
Dana-Farber Cancer Institute ( Site 1956) Boston Massachusetts
University of Michigan ( Site 1915) Ann Arbor Michigan
Cancer and Hematology Centers of Western Michigan ( Site 1932) Grand Rapids Michigan
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944) Hackensack New Jersey
Atlantic Health System ( Site 1925) Morristown New Jersey
Valley Health Systems - Ridgewood Campus ( Site 1947) Ridgewood New Jersey
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958) Mineola New York
NYU Langone Health-Perlmutter Cancer Center ( Site 1917) New York New York
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 1908) New York New York
Memorial Sloan Kettering Cancer Center ( Site 1914) New York New York
University of North Carolina Medical Center-Lineberger Comprehensive Cancer Center ( Site 1949) Chapel Hill North Carolina
Duke Cancer Institute ( Site 1911) Durham North Carolina
Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 1905) Philadelphia Pennsylvania
UPMC Hillman Cancer Center ( Site 1909) Pittsburgh Pennsylvania
Medical University of South Carolina-Hollings Cancer Center ( Site 1934) Charleston South Carolina
Sanford Cancer Center ( Site 1951) Sioux Falls South Dakota
SCRI Oncology Partners ( Site 1910) Nashville Tennessee
Texas Oncology - Austin ( Site 1903) Austin Texas
Texas Oncology - Dallas (Sammons) ( Site 1902) Dallas Texas
University of Texas MD Anderson Cancer Center ( Site 1920) Houston Texas
Inova Schar Cancer Institute ( Site 1900) Fairfax Virginia
Fred Hutchinson Cancer Center ( Site 1901) Seattle Washington
Clinica Adventista Belgrano-Oncology ( Site 2204) Caba. Buenos Aires
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2202) Ciudad Autonoma de Buenos Aires Buenos Aires
Instituto Alexander Fleming-Alexander Fleming ( Site 2203) Buenos Aires Buenos Aires F.D.
Centro Privado de RMI Río Cuarto S.A. II ( Site 2201) Río Cuarto Córdoba Province
Hospital Aleman ( Site 2200) Buenos Aires Argentina
Sanatorio Finochietto ( Site 2205) Buenos Aires Argentina

+ 125 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Merck Sharp & Dohme LLC trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05933577 on ClinicalTrials.gov ↗ ← All trials in the UK