A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
NCT ID: NCT05933577
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1089 participants
INTERVENTIONAL
2023-07-19
2030-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intismeran autogene + Pembrolizumab
Participants receive up to 9 doses of intismeran autogene via an intramuscular (IM) injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an intravenous (IV) infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.
Intismeran autogene
IM injection
Pembrolizumab
IV infusion
Placebo + Pembrolizumab
Participants receive up to 9 doses of dose matched placebo to intismeran autogene via an IM injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an IV infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.
Pembrolizumab
IV infusion
Placebo
IM injection
Interventions
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Intismeran autogene
IM injection
Pembrolizumab
IV infusion
Placebo
IM injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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ModernaTX, Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Emek Medical Center ( Site 2003)
Afula, , Israel
Hadassah Medical Center ( Site 2004)
Jerusalem, , Israel
Rabin Medical Center ( Site 2000)
Petah Tikva, , Israel
Sheba Medical Center ( Site 2001)
Ramat Gan, , Israel
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)
Milan, Lombardy, Italy
Istituto Europeo di Oncologia IRCCS ( Site 1404)
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 1402)
Siena, Tuscany, Italy
AO Santa Maria della Misericordia ( Site 1403)
Perugia, Umbria, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi ( Site 1400)
Napoli, , Italy
Nagoya University Hospital ( Site 4201)
Nagoya, Aichi-ken, Japan
Shizuoka Cancer Center ( Site 4202)
Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital ( Site 4200)
Chūō, Tokyo, Japan
Capital, Coast and Hutt Valley District - Wellington Regional Hospital ( Site 1502)
Newtown, Wellington Region, New Zealand
Harbour Cancer & Wellness ( Site 1500)
Auckland, , New Zealand
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2909)
Poznan, Greater Poland Voivodeship, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2908)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2903)
Siedlce, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2900)
Warsaw, Masovian Voivodeship, Poland
Bialostockie Centrum Onkologii ( Site 2905)
Bialystok, Podlaskie Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site 2906)
Gdansk, Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2907)
Gliwice, Silesian Voivodeship, Poland
Zachodniopomorskie Centrum Onkologii ( Site 2904)
Szczecin, West Pomeranian Voivodeship, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 2902)
Kielce, Świętokrzyskie Voivodeship, Poland
Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3601)
Lisbon, Lisbon District, Portugal
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3602)
Lisbon, , Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3603)
Lisbon, , Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3604)
Porto, , Portugal
Medical Oncology Centre of Rosebank ( Site 4106)
Johannesburg, Gauteng, South Africa
Wilgers Oncology Centre ( Site 4103)
Pretoria, Gauteng, South Africa
Cape Town Oncology Trials ( Site 4100)
Cape Town, Western Cape, South Africa
Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 3904)
Daegu, Taegu-Kwangyokshi, South Korea
Chungnam national university hospital-Department of Internal Medicine ( Site 3903)
Daejeon, Taejon-Kwangyokshi, South Korea
Seoul National University Hospital-Oncology ( Site 3902)
Seoul, , South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3901)
Seoul, , South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 3900)
Seoul, , South Korea
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1600)
Barcelona, Catalonia, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1603)
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Ramón y Cajal ( Site 1602)
Madrid, Madrid, Comunidad de, Spain
H.R.U Málaga - Hospital General-Oncology ( Site 1605)
Málaga, Malaga, Spain
HOSPITAL CLINICO DE VALENCIA ( Site 1604)
Valencia, Valenciana, Comunitat, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1601)
Barcelona, , Spain
Skånes Universitetssjukhus Lund ( Site 3201)
Lund, Skåne County, Sweden
Sahlgrenska Universitetssjukhuset ( Site 3200)
Gothenburg, Västra Götaland County, Sweden
UniversitätsSpital Zürich-Dermatology ( Site 1700)
Zürich Flughafen, Canton of Zurich, Switzerland
Kantonsspital Graubünden-Medizin ( Site 1703)
Chur, Kanton Graubünden, Switzerland
Chang Gung Memorial Hospital at Kaohsiung ( Site 4000)
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 4004)
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 4001)
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 4003)
Taoyuan District, , Taiwan
Hacettepe Universite Hastaneleri ( Site 3006)
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 3010)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 3002)
Ankara, , Turkey (Türkiye)
Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 3008)
Istanbul, , Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3003)
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty Hospital ( Site 3011)
Izmir, , Turkey (Türkiye)
I.E.U. Medical Point Hastanesi-Oncology ( Site 3005)
Izmir, , Turkey (Türkiye)
Bristol Haematology and Oncology Centre ( Site 1811)
Bristol, Bristol, City of, United Kingdom
Addenbrooke's Hospital ( Site 1800)
Cambridge, Cambridgeshire, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust ( Site 1813)
Cringleford, England, United Kingdom
University College London Hospital ( Site 1807)
London, London, City of, United Kingdom
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1804)
London, London, City of, United Kingdom
Western General Hospital ( Site 1806)
Edinburgh, Midlothian, United Kingdom
The Churchill Hospital ( Site 1805)
Oxford, Oxfordshire, United Kingdom
St James's University Hospital-Leeds Cancer Centre ( Site 1808)
Leeds, , United Kingdom
The Christie NHS Foundation Trust ( Site 1814)
Manchester, , United Kingdom
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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V940-001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-503652-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2041230169
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1287-6366
Identifier Type: REGISTRY
Identifier Source: secondary_id
V940-001
Identifier Type: -
Identifier Source: org_study_id
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