Clinical Research Directory
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A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: 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 (INTerpath-001)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1089
Start Date
2023-07-19
Completion Date
2030-09-26
Last Updated
2025-09-24
Healthy Volunteers
No
Conditions
Interventions
Intismeran autogene
IM injection
Pembrolizumab
IV infusion
Placebo
IM injection
Locations (165)
Highlands Oncology Group ( Site 1943)
Springdale, Arkansas, United States
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
UPMC Hillman Cancer Center ( Site 1909)
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina-Hollings Cancer Center ( Site 1934)
Charleston, South Carolina, United States
Sanford Cancer Center ( Site 1951)
Sioux Falls, South Dakota, United States
SCRI Oncology Partners ( Site 1910)
Nashville, Tennessee, United States
Texas Oncology - Austin ( Site 1903)
Austin, Texas, United States
Texas Oncology - Dallas (Sammons) ( Site 1902)
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center ( Site 1920)
Houston, Texas, United States
Inova Schar Cancer Institute ( Site 1900)
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center ( Site 1901)
Seattle, Washington, United States
Clinica Adventista Belgrano-Oncology ( Site 2204)
Caba., Buenos Aires, Argentina
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2202)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming-Alexander Fleming ( Site 2203)
Buenos Aires, Buenos Aires F.D., Argentina
Centro Privado de RMI Río Cuarto S.A. II ( Site 2201)
Río Cuarto, Córdoba Province, Argentina
Hospital Aleman ( Site 2200)
Buenos Aires, Argentina
Sanatorio Finochietto ( Site 2205)
Buenos Aires, Argentina
Westmead Hospital ( Site 1001)
Westmead, New South Wales, Australia
Melanoma Institute Australia-Clinical Trials Unit ( Site 1000)
Wollstonecraft, New South Wales, Australia
Princess Alexandra Hospital ( Site 1003)
Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1005)
Melbourne, Victoria, Australia
Paula Fox Melanoma & Cancer Centre ( Site 1004)
Melbourne, Victoria, Australia
One Clinical Research ( Site 1002)
Nedlands, Western Australia, Australia
UZ Brussel-Medische oncologie ( Site 3405)
Brussels, Bruxelles-Capitale, Region de, Belgium
Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3402)
Genk, Limburg, Belgium
UZ Gent ( Site 3403)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 3400)
Leuven, Vlaams-Brabant, Belgium
AZ Groeninge Campus Kennedylaan-Oncology ( Site 3401)
Kortrijk, West-Vlaanderen, Belgium
Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 2303)
Belo Horizonte, Minas Gerais, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 2302)
Ijuí, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceição ( Site 2309)
Porto Alegre, Rio Grande do Sul, Brazil
Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC II ( Site 2305)
Rio de Janeiro, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300)
São Paulo, Brazil
Cross Cancer Institute ( Site 1104)
Edmonton, Alberta, Canada
BC Cancer Vancouver-Clinical Trials Unit ( Site 1106)
Vancouver, British Columbia, Canada
William Osler Health System ( Site 1105)
Brampton, Ontario, Canada
Sunnybrook Research Institute ( Site 1103)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 1102)
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal-Unité de Recherche Clinique en Oncologie et Hématolo ( Site 1100)
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université L-Hemato-Oncology ( Site 1101)
Québec, Quebec, Canada
FALP-UIDO ( Site 2400)
Santiago, Region M. de Santiago, Chile
Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 2402)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 2401)
Santiago, Region M. de Santiago, Chile
Clinica Somer-Unidad de Investigacion y Docencia ( Site 2506)
Rionegro, Antioquia, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2500)
Bogotá, Bogota D.C., Colombia
IMAT S.A.S ( Site 2503)
Montería, Departamento de Córdoba, Colombia
Fundación Valle del Lili ( Site 2505)
Cali, Valle del Cauca Department, Colombia
Herlev and Gentofte Hospital ( Site 3301)
Copenhagen, Capital Region, Denmark
Aalborg Universitetshospital, Syd ( Site 3302)
Aalborg, North Denmark, Denmark
Odense Universitetshospital ( Site 3300)
Odense C, Region Syddanmark, Denmark
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 1211)
Nice, Alpes-Maritimes, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi ( Site 1203)
Marseille, Bouches-du-Rhone, France
Centre Georges François Leclerc ( Site 1210)
Dijon, Cote-d Or, France
CHU Besançon ( Site 1209)
Besançon, Doubs, France
CHU de Bordeaux Hop St ANDRE-Service de Dermatologie ( Site 1204)
Bordeaux, Gironde, France
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1206)
Rennes, Ille-et-Vilaine, France
Hopital Claude Huriez - CHU de Lille ( Site 1207)
Lille, Nord, France
centre hospitalier lyon sud-Service de dermatologie ( Site 1202)
Pierre-Bénite, Rhone, France
CHU d'Amiens-Picardie - Hôpital Sud-Dermatologie ( Site 1208)
Amiens, Somme, France
Gustave Roussy-Dermatologie ( Site 1201)
Villejuif, Val-de-Marne, France
Hôpital Saint-Louis ( Site 1200)
Paris, France
Universitätsmedizin Mannheim ( Site 1305)
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Augsburg ( Site 1312)
Augsburg, Bavaria, Germany
Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 1315)
München, Bavaria, Germany
Universitätsmedizin Göttingen - Georg-August-Universität-Dermatology ( Site 1308)
Göttingen, Lower Saxony, Germany
Universitätsmedizin Rostock-Klinik und Poliklinik für Dermatologie und Venerologie ( Site 1310)
Rostock, Mecklenburg-Vorpommern, Germany
Universitaetsklinikum Koeln ( Site 1307)
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 1300)
Essen, North Rhine-Westphalia, Germany
Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 1301)
Minden, North Rhine-Westphalia, Germany
Universitaetsklinikum des Saarlandes ( Site 1313)
Homburg, Saarland, Germany
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1306)
Gera, Thuringia, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 1302)
Berlin, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 1309)
Hamburg, Germany
General Hospital of Athens "Laiko"-First Department of Internal Medicine ( Site 3700)
Athens, Attica, Greece
Metropolitan Hospital-A' Oncology Dpt ( Site 3701)
Neo Faliro, Attica, Greece
Bioclinic Thessalonikis Private Clinic Single Member S.A.-Oncology ( Site 3703)
Thessaloniki, Central Macedonia, Greece
European Interbalkan Medical Center-Oncology Department ( Site 3702)
Thessaloniki, Greece