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ACTIVE NOT RECRUITING
NCT05933577
PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

BIOLOGICAL

Intismeran autogene

IM injection

BIOLOGICAL

Pembrolizumab

IV infusion

OTHER

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

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)

Naples, 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, 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