A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Recurrence-Free Survival (RFS) — Up to approximately 74 months
RFS is defined as the length of time from when the participant starts the study until either the cancer comes back, or the cancer spreads as assessed by the investigator, or death due to any cause.
Trial sites (165)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 South Korea
Other trials for the same condition
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 South Korea