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

September 22, 2025 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1089

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • Hospital Aleman ( Site 2200)
      • Buenos Aires, Argentina, C1187AAN
        • Sanatorio Finochietto ( Site 2205)
    • Buenos Aires
      • Caba., Buenos Aires, Argentina, C1430EGF
        • Clinica Adventista Belgrano-Oncology ( Site 2204)
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2202)
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, 1426ANZ
        • Instituto Alexander Fleming-Alexander Fleming ( Site 2203)
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, X5800ALB
        • Centro Privado de RMI Río Cuarto S.A. II ( Site 2201)
  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital ( Site 1001)
      • Wollstonecraft, New South Wales, Australia, 2065
        • Melanoma Institute Australia-Clinical Trials Unit ( Site 1000)
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Princess Alexandra Hospital ( Site 1003)
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1005)
      • Melbourne, Victoria, Australia, 3004
        • Paula Fox Melanoma & Cancer Centre ( Site 1004)
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • One Clinical Research ( Site 1002)
  • Belgium
    • Bruxelles-Capitale, Region de
      • Brussels, Bruxelles-Capitale, Region de, Belgium, 1090
        • UZ Brussel-Medische oncologie ( Site 3405)
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3402)
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent ( Site 3403)
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven ( Site 3400)
    • West-Vlaanderen
      • Kortrijk, West-Vlaanderen, Belgium, 8500
        • AZ Groeninge Campus Kennedylaan-Oncology ( Site 3401)
  • Brazil
      • Rio de Janeiro, Brazil, 20220-410
        • Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC II ( Site 2305)
      • São Paulo, Brazil, 01246-000
        • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300)
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-090
        • Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 2303)
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 2302)
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceição ( Site 2309)
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute ( Site 1104)
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Vancouver-Clinical Trials Unit ( Site 1106)
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health System ( Site 1105)
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute ( Site 1103)
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 1102)
    • Quebec
      • Montreal, Quebec, Canada, H2X 0X9
        • Centre Hospitalier de l'Université de Montréal-Unité de Recherche Clinique en Oncologie et Hématolo ( Site 1100)
      • Québec, Quebec, Canada, G1J 1Z4
        • Centre intégré de cancérologie du CHU de Québec Université L-Hemato-Oncology ( Site 1101)
  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • FALP-UIDO ( Site 2400)
      • Santiago, Region M. de Santiago, Chile, 7620002
        • Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 2402)
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Bradfordhill ( Site 2401)
  • Colombia
    • Antioquia
      • Rionegro, Antioquia, Colombia, 054040
        • Clinica Somer-Unidad de Investigacion y Docencia ( Site 2506)
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 111321
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2500)
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • IMAT S.A.S ( Site 2503)
    • Valle del Cauca Department
      • Santiago de Cali, Valle del Cauca Department, Colombia, 760032
        • Fundación Valle del Lili ( Site 2505)
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2730
        • Herlev and Gentofte Hospital ( Site 3301)
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Aalborg Universitetshospital, Syd ( Site 3302)
    • Region Syddanmark
      • Odense C, Region Syddanmark, Denmark, 5000
        • Odense Universitetshospital ( Site 3300)
  • France
      • Paris, France, 75010
        • Hôpital Saint-Louis ( Site 1200)
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06200
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 1211)
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13385
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi ( Site 1203)
    • Cote-d Or
      • Dijon, Cote-d Or, France, 21079
        • Centre Georges François Leclerc ( Site 1210)
    • Doubs
      • Besançon, Doubs, France, 25030
        • CHU Besançon ( Site 1209)
    • Gironde
      • Bordeaux, Gironde, France, 33075
        • CHU de Bordeaux Hop St ANDRE-Service de Dermatologie ( Site 1204)
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35042
        • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1206)
    • Nord
      • Lille, Nord, France, 59037
        • Hopital Claude Huriez - CHU de Lille ( Site 1207)
    • Rhone
      • Pierre-Bénite, Rhone, France, 69310
        • centre hospitalier lyon sud-Service de dermatologie ( Site 1202)
    • Somme
      • Amiens, Somme, France, 80054
        • CHU d'Amiens-Picardie - Hôpital Sud-Dermatologie ( Site 1208)
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Gustave Roussy-Dermatologie ( Site 1201)
  • Germany
      • Berlin, Germany, 10115
        • Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 1302)
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf ( Site 1309)
    • Baden-Wurttemberg
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • Universitätsmedizin Mannheim ( Site 1305)
    • Bavaria
      • Augsburg, Bavaria, Germany, 86156
        • Universitaetsklinikum Augsburg ( Site 1312)
      • München, Bavaria, Germany, 80337
        • Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 1315)
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • Universitätsmedizin Göttingen - Georg-August-Universität-Dermatology ( Site 1308)
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18057
        • Universitätsmedizin Rostock-Klinik und Poliklinik für Dermatologie und Venerologie ( Site 1310)
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Universitaetsklinikum Koeln ( Site 1307)
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 1300)
      • Minden, North Rhine-Westphalia, Germany, 32429
        • Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 1301)
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Universitaetsklinikum des Saarlandes ( Site 1313)
    • Thuringia
      • Gera, Thuringia, Germany, 07548
        • SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1306)
  • Greece
      • Thessaloniki, Greece, 570 01
        • European Interbalkan Medical Center-Oncology Department ( Site 3702)
    • Attica
      • Athens, Attica, Greece, 115 26
        • General Hospital of Athens "Laiko"-First Department of Internal Medicine ( Site 3700)
      • Neo Faliro, Attica, Greece, 185 47
        • Metropolitan Hospital-A' Oncology Dpt ( Site 3701)
    • Central Macedonia
      • Thessaloniki, Central Macedonia, Greece, 546 22
        • Bioclinic Thessalonikis Private Clinic Single Member S.A.-Oncology ( Site 3703)
  • Israel
      • Afula, Israel, 1834111
        • Emek Medical Center ( Site 2003)
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center ( Site 2004)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center ( Site 2000)
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center ( Site 2001)
  • Italy
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi ( Site 1400)
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)
      • Milan, Lombardy, Italy, 20141
        • Istituto Europeo di Oncologia IRCCS ( Site 1404)
    • Tuscany
      • Siena, Tuscany, Italy, 53100
        • Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 1402)
    • Umbria
      • Perugia, Umbria, Italy, 06129
        • AO Santa Maria della Misericordia ( Site 1403)
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Nagoya University Hospital ( Site 4201)
    • Shizuoka
      • Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center ( Site 4202)
    • Tokyo
      • Chūō, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital ( Site 4200)
  • New Zealand
      • Auckland, New Zealand, 1023
        • Harbour Cancer & Wellness ( Site 1500)
    • Wellington Region
      • Newtown, Wellington Region, New Zealand, 6021
        • Capital, Coast and Hutt Valley District - Wellington Regional Hospital ( Site 1502)
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-569
        • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2909)
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2908)
    • Masovian Voivodeship
      • Siedlce, Masovian Voivodeship, Poland, 08-110
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2903)
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2900)
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-027
        • Bialostockie Centrum Onkologii ( Site 2905)
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site 2906)
    • Silesian Voivodeship
      • Gliwice, Silesian Voivodeship, Poland, 44-101
        • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2907)
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-730
        • Zachodniopomorskie Centrum Onkologii ( Site 2904)
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 2902)
  • Portugal
      • Lisbon, Portugal, 1449-005
        • Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3602)
      • Lisbon, Portugal, 1649-035
        • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3603)
      • Porto, Portugal, 4200-072
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3604)
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1099-023
        • Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3601)
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
        • Medical Oncology Centre of Rosebank ( Site 4106)
      • Pretoria, Gauteng, South Africa, 0040
        • Wilgers Oncology Centre ( Site 4103)
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7570
        • Cape Town Oncology Trials ( Site 4100)
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital-Oncology ( Site 3902)
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3901)
      • Seoul, South Korea, 06351
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 3900)
    • Taegu-Kwangyokshi
      • Daegu, Taegu-Kwangyokshi, South Korea, 41404
        • Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 3904)
    • Taejon-Kwangyokshi
      • Daejeon, Taejon-Kwangyokshi, South Korea, 35015
        • Chungnam national university hospital-Department of Internal Medicine ( Site 3903)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1601)
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1600)
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1603)
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Hospital Universitario Ramón y Cajal ( Site 1602)
    • Malaga
      • Málaga, Malaga, Spain, 29011
        • H.R.U Málaga - Hospital General-Oncology ( Site 1605)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • HOSPITAL CLINICO DE VALENCIA ( Site 1604)
  • Sweden
    • Skåne County
      • Lund, Skåne County, Sweden, 22185
        • Skånes Universitetssjukhus Lund ( Site 3201)
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset ( Site 3200)
  • Switzerland
    • Canton of Zurich
      • Zürich Flughafen, Canton of Zurich, Switzerland, 8058
        • UniversitätsSpital Zürich-Dermatology ( Site 1700)
    • Kanton Graubünden
      • Chur, Kanton Graubünden, Switzerland, 7000
        • Kantonsspital Graubünden-Medizin ( Site 1703)
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Chang Gung Memorial Hospital at Kaohsiung ( Site 4000)
      • Tainan City, Taiwan, 704
        • National Cheng Kung University Hospital-Clinical Trial Center ( Site 4004)
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital ( Site 4001)
      • Taoyuan District, Taiwan, 33305
        • Chang Gung Medical Foundation-Linkou Branch ( Site 4003)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universite Hastaneleri ( Site 3006)
      • Ankara, Turkey (Türkiye), 06520
        • Memorial Ankara Hastanesi-Medical Oncology ( Site 3010)
      • Ankara, Turkey (Türkiye), 06800
        • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 3002)
      • Istanbul, Turkey (Türkiye), 34303
        • Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 3008)
      • Istanbul, Turkey (Türkiye), 34722
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3003)
      • Izmir, Turkey (Türkiye), 35100
        • Ege University Medical Faculty Hospital ( Site 3011)
      • Izmir, Turkey (Türkiye), 35575
        • I.E.U. Medical Point Hastanesi-Oncology ( Site 3005)
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • St James's University Hospital-Leeds Cancer Centre ( Site 1808)
      • Manchester, United Kingdom, m20 4bx
        • The Christie NHS Foundation Trust ( Site 1814)
    • Bristol, City of
      • Bristol, Bristol, City of, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre ( Site 1811)
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital ( Site 1800)
    • England
      • Cringleford, England, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospitals NHS Foundation Trust ( Site 1813)
    • London, City of
      • London, London, City of, United Kingdom, NW1 2PG
        • University College London Hospital ( Site 1807)
      • London, London, City of, United Kingdom, SW3 6JJ
        • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1804)
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH4 2XU
        • Western General Hospital ( Site 1806)
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • The Churchill Hospital ( Site 1805)
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group ( Site 1943)
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918)
      • San Francisco, California, United States, 94158
        • UCSF Medical Center at Mission Bay ( Site 1929)
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale-New Haven Hospital-Yale Cancer Center ( Site 1933)
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health Cancer Institute ( Site 1937)
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945)
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University ( Site 1940)
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa-Holden Comprehensive Cancer Center ( Site 1935)
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912)
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital ( Site 1927)
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center ( Site 1957)
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute ( Site 1956)
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan ( Site 1915)
      • Grand Rapids, Michigan, United States, 49503
        • Cancer and Hematology Centers of Western Michigan ( Site 1932)
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944)
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health System ( Site 1925)
      • Ridgewood, New Jersey, United States, 07450
        • Valley Health Systems - Ridgewood Campus ( Site 1947)
    • New York
      • Mineola, New York, United States, 11501
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958)
      • New York, New York, United States, 10016
        • NYU Langone Health-Perlmutter Cancer Center ( Site 1917)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center ( Site 1914)
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 1908)
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Medical Center-Lineberger Comprehensive Cancer Center ( Site 1949)
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Institute ( Site 1911)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 1905)
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Center ( Site 1909)
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina-Hollings Cancer Center ( Site 1934)
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center ( Site 1951)
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • SCRI Oncology Partners ( Site 1910)
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology - Austin ( Site 1903)
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Dallas (Sammons) ( Site 1902)
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center ( Site 1920)
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute ( Site 1900)
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center ( Site 1901)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • Keytruda®
Biological: Intismeran autogene
IM injection
Other Names:
  • mRNA-4157
  • Individualized neoantigen therapy
  • V940
Active Comparator: 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.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • Keytruda®
Other: Placebo
IM injection
Other Names:
  • Normal saline
  • Dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-Free Survival (RFS)
Time Frame: 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.
Up to approximately 74 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distant Metastasis-Free Survival (DMFS)
Time Frame: Up to approximately 85 months
DMFS is the length of time from when the participant starts the study until either the cancer spreads from where it started to other parts of the body as assessed by the investigator, or death due to any cause.
Up to approximately 85 months
Overall-Survival (OS)
Time Frame: Up to approximately 85 months
OS is the length of time that people are alive after joining the study.
Up to approximately 85 months
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 68 weeks
An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported.
Up to approximately 68 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 56 weeks
An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported.
Up to approximately 56 weeks
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
Time Frame: Baseline and up to approximately 85 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Baseline and up to approximately 85 months
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Time Frame: Baseline and up to approximately 85 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better level of physical functioning. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.
Baseline and up to approximately 85 months
Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
Time Frame: Baseline and up to approximately 85 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a more impaired level of role functioning. Change from baseline in the role functioning (EORTC QLQ-C30 Items 6-7) combined score will be presented.
Baseline and up to approximately 85 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

ModernaTX, Inc.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2023

Primary Completion (Estimated)

October 26, 2029

Study Completion (Estimated)

September 26, 2030

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V940-001 (Other Identifier: MSD)
  • 2023-503652-27-00 (Registry Identifier: EU CT)
  • jRCT2041230169 (Registry Identifier: jRCT)
  • U1111-1287-6366 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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