AzTrials
AzTrials

MelanomaPhase 3NCT05933577

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

A Phase 3 study testing Intismeran autogene and Pembrolizumab in people with Melanoma, run by Merck Sharp & Dohme LLC at 165 sites in 26 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Intismeran autogene and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,089 participants
Where
165 sitesin 26 countries
Study dates
19 Jul 2023to 26 Sep 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

165 sites in 26 countries.

165 sites in 26 countries

United States34 sites

  • University of Michigan ( Site 1915)

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute of Emory University ( Site 1940)

    Atlanta, Georgia, 30322

  • Texas Oncology - Austin ( Site 1903)

    Austin, Texas, 78731

  • Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912)

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital ( Site 1927)

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center ( Site 1957)

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute ( Site 1956)

    Boston, Massachusetts, 02215

  • University of North Carolina Medical Center-Lineberger Comprehensive Cancer Center ( Site 1949)

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina-Hollings Cancer Center ( Site 1934)

    Charleston, South Carolina, 29425

  • Texas Oncology - Dallas (Sammons) ( Site 1902)

    Dallas, Texas, 75246

  • Duke Cancer Institute ( Site 1911)

    Durham, North Carolina, 27710

  • Inova Schar Cancer Institute ( Site 1900)

    Fairfax, Virginia, 22031

  • Cancer and Hematology Centers of Western Michigan ( Site 1932)

    Grand Rapids, Michigan, 49503

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944)

    Hackensack, New Jersey, 07601

  • University of Texas MD Anderson Cancer Center ( Site 1920)

    Houston, Texas, 77030

  • University of Iowa-Holden Comprehensive Cancer Center ( Site 1935)

    Iowa City, Iowa, 52242

  • UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918)

    Los Angeles, California, 90095

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950)

    Marietta, Georgia, 30060

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958)

    Mineola, New York, 11501

  • Atlantic Health System ( Site 1925)

    Morristown, New Jersey, 07960

  • SCRI Oncology Partners ( Site 1910)

    Nashville, Tennessee, 37203

  • Yale-New Haven Hospital-Yale Cancer Center ( Site 1933)

    New Haven, Connecticut, 06510

  • NYU Langone Health-Perlmutter Cancer Center ( Site 1917)

    New York, New York, 10016

  • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 1908)

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center ( Site 1914)

    New York, New York, 10065

  • Orlando Health Cancer Institute ( Site 1937)

    Orlando, Florida, 32806

  • Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 1905)

    Philadelphia, Pennsylvania, 19104

  • UPMC Hillman Cancer Center ( Site 1909)

    Pittsburgh, Pennsylvania, 15232

  • Valley Health Systems - Ridgewood Campus ( Site 1947)

    Ridgewood, New Jersey, 07450

  • UCSF Medical Center at Mission Bay ( Site 1929)

    San Francisco, California, 94158

  • Fred Hutchinson Cancer Center ( Site 1901)

    Seattle, Washington, 98109

  • Sanford Cancer Center ( Site 1951)

    Sioux Falls, South Dakota, 57104

  • Highlands Oncology Group ( Site 1943)

    Springdale, Arkansas, 72762

  • Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945)

    Tampa, Florida, 33612

Other trials in United States

Germany12 sites

  • Universitaetsklinikum Augsburg ( Site 1312)

    Augsburg, Bavaria, 86156

  • Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 1302)

    Berlin, 10115

  • Universitaetsklinikum Koeln ( Site 1307)

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 1300)

    Essen, North Rhine-Westphalia, 45147

  • SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1306)

    Gera, Thuringia, 07548

  • Universitätsmedizin Göttingen - Georg-August-Universität-Dermatology ( Site 1308)

    Göttingen, Lower Saxony, 37075

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 1309)

    Hamburg, 20246

  • Universitaetsklinikum des Saarlandes ( Site 1313)

    Homburg, Saarland, 66424

  • Universitätsmedizin Mannheim ( Site 1305)

    Mannheim, Baden-Wurttemberg, 68167

  • Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 1301)

    Minden, North Rhine-Westphalia, 32429

  • Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 1315)

    München, Bavaria, 80337

  • Universitätsmedizin Rostock-Klinik und Poliklinik für Dermatologie und Venerologie ( Site 1310)

    Rostock, Mecklenburg-Vorpommern, 18057

Other trials in Germany

France11 sites

  • CHU d'Amiens-Picardie - Hôpital Sud-Dermatologie ( Site 1208)

    Amiens, Somme, 80054

  • CHU Besançon ( Site 1209)

    Besançon, Doubs, 25030

  • CHU de Bordeaux Hop St ANDRE-Service de Dermatologie ( Site 1204)

    Bordeaux, Gironde, 33075

  • Centre Georges François Leclerc ( Site 1210)

    Dijon, Cote-d Or, 21079

  • Hopital Claude Huriez - CHU de Lille ( Site 1207)

    Lille, Nord, 59037

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi ( Site 1203)

    Marseille, Bouches-du-Rhone, 13385

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 1211)

    Nice, Alpes-Maritimes, 06200

  • Hôpital Saint-Louis ( Site 1200)

    Paris, 75010

  • centre hospitalier lyon sud-Service de dermatologie ( Site 1202)

    Pierre-Bénite, Rhone, 69310

  • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1206)

    Rennes, Ille-et-Vilaine, 35042

  • Gustave Roussy-Dermatologie ( Site 1201)

    Villejuif, Val-de-Marne, 94800

Other trials in France

Poland9 sites

  • Bialostockie Centrum Onkologii ( Site 2905)

    Bialystok, Podlaskie Voivodeship, 15-027

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2908)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site 2906)

    Gdansk, Pomeranian Voivodeship, 80-214

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2907)

    Gliwice, Silesian Voivodeship, 44-101

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 2902)

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2909)

    Poznan, Greater Poland Voivodeship, 60-569

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2903)

    Siedlce, Masovian Voivodeship, 08-110

  • Zachodniopomorskie Centrum Onkologii ( Site 2904)

    Szczecin, West Pomeranian Voivodeship, 71-730

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2900)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

United Kingdom9 sites

  • Bristol Haematology and Oncology Centre ( Site 1811)

    Bristol, Bristol, City of, BS2 8ED

  • Addenbrooke's Hospital ( Site 1800)

    Cambridge, Cambridgeshire, CB2 2QQ

  • Norfolk and Norwich University Hospitals NHS Foundation Trust ( Site 1813)

    Cringleford, England, NR4 7UY

  • Western General Hospital ( Site 1806)

    Edinburgh, Midlothian, EH4 2XU

  • St James's University Hospital-Leeds Cancer Centre ( Site 1808)

    Leeds, LS9 7TF

  • University College London Hospital ( Site 1807)

    London, London, City of, NW1 2PG

  • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1804)

    London, London, City of, SW3 6JJ

  • The Christie NHS Foundation Trust ( Site 1814)

    Manchester, m20 4bx

  • The Churchill Hospital ( Site 1805)

    Oxford, Oxfordshire, OX3 7LE

Other trials in United Kingdom

Canada7 sites

  • William Osler Health System ( Site 1105)

    Brampton, Ontario, L6R 3J7

  • Cross Cancer Institute ( Site 1104)

    Edmonton, Alberta, T6G 1Z2

  • Centre Hospitalier de l'Université de Montréal-Unité de Recherche Clinique en Oncologie et Hématolo ( Site 1100)

    Montreal, Quebec, H2X 0X9

  • Centre intégré de cancérologie du CHU de Québec Université L-Hemato-Oncology ( Site 1101)

    Québec, Quebec, G1J 1Z4

  • Sunnybrook Research Institute ( Site 1103)

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 1102)

    Toronto, Ontario, M5G 2M9

  • BC Cancer Vancouver-Clinical Trials Unit ( Site 1106)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Turkey (Türkiye)7 sites

  • Hacettepe Universite Hastaneleri ( Site 3006)

    Ankara, 06230

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 3010)

    Ankara, 06520

  • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 3002)

    Ankara, 06800

  • Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 3008)

    Istanbul, 34303

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3003)

    Istanbul, 34722

  • Ege University Medical Faculty Hospital ( Site 3011)

    Izmir, 35100

  • I.E.U. Medical Point Hastanesi-Oncology ( Site 3005)

    Izmir, 35575

Other trials in Turkey (Türkiye)

Argentina6 sites

  • Instituto Alexander Fleming-Alexander Fleming ( Site 2203)

    Buenos Aires, Buenos Aires F.D., 1426ANZ

  • Hospital Aleman ( Site 2200)

    Buenos Aires, C1118AAT

  • Sanatorio Finochietto ( Site 2205)

    Buenos Aires, C1187AAN

  • Clinica Adventista Belgrano-Oncology ( Site 2204)

    Caba., Buenos Aires, C1430EGF

  • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2202)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB

  • Centro Privado de RMI Río Cuarto S.A. II ( Site 2201)

    Río Cuarto, Córdoba Province, X5800ALB

Other trials in Argentina

Australia6 sites

  • Princess Alexandra Hospital ( Site 1003)

    Brisbane, Queensland, 4102

  • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1005)

    Melbourne, Victoria, 3000

  • Paula Fox Melanoma & Cancer Centre ( Site 1004)

    Melbourne, Victoria, 3004

  • One Clinical Research ( Site 1002)

    Nedlands, Western Australia, 6009

  • Westmead Hospital ( Site 1001)

    Westmead, New South Wales, 2145

  • Melanoma Institute Australia-Clinical Trials Unit ( Site 1000)

    Wollstonecraft, New South Wales, 2065

Other trials in Australia

Spain6 sites

  • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1600)

    Barcelona, Catalonia, 08036

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1601)

    Barcelona, 08035

  • Hospital Universitario Ramón y Cajal ( Site 1602)

    Madrid, Madrid, Comunidad de, 28034

  • H.R.U Málaga - Hospital General-Oncology ( Site 1605)

    Málaga, Malaga, 29011

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1603)

    Pozuelo de Alarcón, Madrid, 28223

  • HOSPITAL CLINICO DE VALENCIA ( Site 1604)

    Valencia, Valenciana, Comunitat, 46010

Other trials in Spain

Belgium5 sites

  • UZ Brussel-Medische oncologie ( Site 3405)

    Brussels, Bruxelles-Capitale, Region de, 1090

  • Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3402)

    Genk, Limburg, 3600

  • UZ Gent ( Site 3403)

    Ghent, Oost-Vlaanderen, 9000

  • AZ Groeninge Campus Kennedylaan-Oncology ( Site 3401)

    Kortrijk, West-Vlaanderen, 8500

  • UZ Leuven ( Site 3400)

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Brazil5 sites

  • Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 2303)

    Belo Horizonte, Minas Gerais, 30130-090

  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 2302)

    Ijuí, Rio Grande do Sul, 98700-000

  • Hospital Nossa Senhora da Conceição ( Site 2309)

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC II ( Site 2305)

    Rio de Janeiro, 20220-410

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300)

    São Paulo, 01246-000

Other trials in Brazil

Italy5 sites

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)

    Milan, Lombardy, 20133

  • Istituto Europeo di Oncologia IRCCS ( Site 1404)

    Milan, Lombardy, 20141

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi ( Site 1400)

    Naples, 80131

  • AO Santa Maria della Misericordia ( Site 1403)

    Perugia, Umbria, 06129

  • Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 1402)

    Siena, Tuscany, 53100

Other trials in Italy

South Korea5 sites

  • Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 3904)

    Daegu, Taegu-Kwangyokshi, 41404

  • Chungnam national university hospital-Department of Internal Medicine ( Site 3903)

    Daejeon, Taejon-Kwangyokshi, 35015

  • Seoul National University Hospital-Oncology ( Site 3902)

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3901)

    Seoul, 03722

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 3900)

    Seoul, 06351

Other trials in South Korea

Colombia4 sites

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2500)

    Bogotá, Bogota D.C., 111321

  • Fundación Valle del Lili ( Site 2505)

    Cali, Valle del Cauca Department, 760032

  • IMAT S.A.S ( Site 2503)

    Montería, Departamento de Córdoba, 230002

  • Clinica Somer-Unidad de Investigacion y Docencia ( Site 2506)

    Rionegro, Antioquia, 054040

Other trials in Colombia

Greece4 sites

  • General Hospital of Athens "Laiko"-First Department of Internal Medicine ( Site 3700)

    Athens, Attica, 115 26

  • Metropolitan Hospital-A' Oncology Dpt ( Site 3701)

    Neo Faliro, Attica, 185 47

  • Bioclinic Thessalonikis Private Clinic Single Member S.A.-Oncology ( Site 3703)

    Thessaloniki, Central Macedonia, 546 22

  • European Interbalkan Medical Center-Oncology Department ( Site 3702)

    Thessaloniki, 570 01

Other trials in Greece

Israel4 sites

  • Emek Medical Center ( Site 2003)

    Afula, 1834111

  • Hadassah Medical Center ( Site 2004)

    Jerusalem, 9112001

  • Rabin Medical Center ( Site 2000)

    Petah Tikva, 4941492

  • Sheba Medical Center ( Site 2001)

    Ramat Gan, 5265601

Other trials in Israel

Portugal4 sites

  • Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3601)

    Lisbon, Lisbon District, 1099-023

  • Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3602)

    Lisbon, 1449-005

  • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3603)

    Lisbon, 1649-035

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3604)

    Porto, 4200-072

Other trials in Portugal

Taiwan4 sites

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 4000)

    Kaohsiung City, 83301

  • National Cheng Kung University Hospital-Clinical Trial Center ( Site 4004)

    Tainan, 704

  • National Taiwan University Hospital ( Site 4001)

    Taipei, 10002

  • Chang Gung Medical Foundation-Linkou Branch ( Site 4003)

    Taoyuan, 33305

Other trials in Taiwan

Chile3 sites

  • FALP-UIDO ( Site 2400)

    Santiago, Region M. de Santiago, 7500921

  • Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 2402)

    Santiago, Region M. de Santiago, 7620002

  • Bradfordhill ( Site 2401)

    Santiago, Region M. de Santiago, 8420383

Other trials in Chile

Denmark3 sites

  • Aalborg Universitetshospital, Syd ( Site 3302)

    Aalborg, North Denmark, 9000

  • Herlev and Gentofte Hospital ( Site 3301)

    Copenhagen, Capital Region, 2730

  • Odense Universitetshospital ( Site 3300)

    Odense C, Region Syddanmark, 5000

Other trials in Denmark

Japan3 sites

  • National Cancer Center Hospital ( Site 4200)

    Chūō, Tokyo, 104-0045

  • Shizuoka Cancer Center ( Site 4202)

    Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777

  • Nagoya University Hospital ( Site 4201)

    Nagoya, Aichi-ken, 466-8560

Other trials in Japan

South Africa3 sites

  • Cape Town Oncology Trials ( Site 4100)

    Cape Town, Western Cape, 7570

  • Medical Oncology Centre of Rosebank ( Site 4106)

    Johannesburg, Gauteng, 2196

  • Wilgers Oncology Centre ( Site 4103)

    Pretoria, Gauteng, 0040

Other trials in South Africa

New Zealand2 sites

  • Harbour Cancer & Wellness ( Site 1500)

    Auckland, 1023

  • Capital, Coast and Hutt Valley District - Wellington Regional Hospital ( Site 1502)

    Newtown, Wellington Region, 6021

Other trials in New Zealand

Sweden2 sites

  • Sahlgrenska Universitetssjukhuset ( Site 3200)

    Gothenburg, Västra Götaland County, 413 45

  • Skånes Universitetssjukhus Lund ( Site 3201)

    Lund, Skåne County, 22185

Other trials in Sweden

Switzerland2 sites

  • Kantonsspital Graubünden-Medizin ( Site 1703)

    Chur, Kanton Graubünden, 7000

  • UniversitätsSpital Zürich-Dermatology ( Site 1700)

    Zürich Flughafen, Canton of Zurich, 8058

Other trials in Switzerland

About this study

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)

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.

Conditions
Melanoma
Being tested
Intismeran autogene, Pembrolizumab, Placebo
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intismeran autogeneBiological

    Also called mRNA-4157, Individualized neoantigen therapy, V940

    IM injection

  • PembrolizumabBiological

    Also called MK-3475, Keytruda®

    IV infusion

  • PlaceboOther

    Also called Normal saline, Dextrose

    IM injection

Study groups in NCT05933577
Study groupRoleWhat they receive
Intismeran autogene + PembrolizumabExperimentalParticipants 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.
Receives: Biological: Intismeran autogene; Biological: Pembrolizumab
Placebo + PembrolizumabActive comparatorParticipants 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.
Receives: Biological: Pembrolizumab; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence-Free Survival (RFS)

    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.

    Measured: Up to approximately 74 months

Secondary outcomes (7)

  1. Distant Metastasis-Free Survival (DMFS)

    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.

    Measured: Up to approximately 85 months

  2. Overall-Survival (OS)

    OS is the length of time that people are alive after joining the study.

    Measured: Up to approximately 85 months

  3. Number of Participants Who Experience an Adverse Event (AE)

    An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported.

    Measured: Up to approximately 68 weeks

  4. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported.

    Measured: Up to approximately 56 weeks

  5. 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

    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.

    Measured: Baseline and up to approximately 85 months

  6. Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30

    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.

    Measured: Baseline and up to approximately 85 months

  7. Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30

    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.

    Measured: Baseline and up to approximately 85 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2023
  2. Study start19 Jul 2023
  3. Primary completion26 Oct 2029 (estimated)
  4. Study completion26 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,089 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05933577
Sponsor's protocol ID
V940-001
Other IDs
V940-001, 2023-503652-27-00, jRCT2041230169, U1111-1287-6366, 2023
Status last verified
Sep 2025
First submitted
27 Jun 2023
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intismeran autogene and Pembrolizumab in people with Melanoma, run by Merck Sharp & Dohme LLC at 165 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in United States, Germany, France, Poland, United Kingdom and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-Free Survival (RFS) (time frame: Up to approximately 74 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05933577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

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