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

April 23, 2024 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 V940 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 V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.

Study Overview

Status

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 Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1187AAN
        • Recruiting
        • Sanatorio Finochietto ( Site 2205)
        • Contact:
          • Study Coordinator
          • Phone Number: 5491158216233
      • Caba, Argentina, 1430
        • Recruiting
        • Clinica Adventista Belgrano-Oncology ( Site 2204)
        • Contact:
          • Study Coordinator
          • Phone Number: 5491132682903
    • Caba
      • Buenos Aires, Caba, Argentina, C1118AAT
        • Recruiting
        • Hospital Aleman ( Site 2200)
        • Contact:
          • Study Coordinator
          • Phone Number: 541148232574
    • Cordoba
      • Río Cuarto, Cordoba, Argentina, X5800ALB
        • Recruiting
        • Centro Privado de RMI Río Cuarto S.A. II ( Site 2201)
        • Contact:
          • Study Coordinator
          • Phone Number: 54351153819050
  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital-Department of Medical Oncology ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: 61298455200
      • Wollstonecraft, New South Wales, Australia, 2065
        • Recruiting
        • Melanoma Institute Australia-Clinical Trials Unit ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: 61299117336
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: 0448632604
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital-Medical Oncology Alfred Cancer Trials ( Site 1004)
        • Contact:
          • Study Coordinator
          • Phone Number: 61390763129
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: +6138559500
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • One Clinical Research ( Site 1002)
        • Contact:
          • Study Coordinator
          • Phone Number: 0410565868
  • Belgium
    • Bruxelles-Capitale, Region De
      • Brussels, Bruxelles-Capitale, Region De, Belgium, 1090
        • Recruiting
        • UZ Brussel-Medische oncologie ( Site 3405)
        • Contact:
          • Study Coordinator
          • Phone Number: 3224775457
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Recruiting
        • Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3402)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 89 32 65 50
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent ( Site 3403)
        • Contact:
          • Study Coordinator
          • Phone Number: 3293320000
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven ( Site 3400)
        • Contact:
          • Study Coordinator
          • Phone Number: 3216346900
    • West-Vlaanderen
      • Kortrijk, West-Vlaanderen, Belgium, 8500
        • Recruiting
        • AZ Groeninge Campus Kennedylaan-Oncology ( Site 3401)
        • Contact:
          • Study Coordinator
          • Phone Number: 3256633900
  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01246-000
        • Recruiting
        • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300)
        • Contact:
          • Study Coordinator
          • Phone Number: 5511999353966
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BC Cancer Vancouver-Clinical Trials Unit ( Site 1106)
        • Contact:
          • Study Coordinator
          • Phone Number: 604-877-6000 EXT 2445
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Recruiting
        • William Osler Health System ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-899-5804
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: 4169464501
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: 4164804757
    • Quebec
      • Montréal, Quebec, Canada, H2X 0X9
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal-Unité de Recherche Clinique en Oncologie et Hématolo
        • Contact:
          • Study Coordinator
          • Phone Number: 5148908444
      • Quebec City, Quebec, Canada, G1J 1Z4
        • Recruiting
        • Centre intégré de cancérologie du CHU de Québec Université L-Hemato-Oncology ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: 4186915200
  • Chile
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 2400)
        • Contact:
          • Study Coordinator
          • Phone Number: 56224457254
      • Santiago, Region M. De Santiago, Chile, 7620002
        • Recruiting
        • Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: 56223546919
      • Santiago, Region M. De Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill-Clinical Area ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +56998744662
  • Denmark
    • Hovedstaden
      • Copenhagen, Hovedstaden, Denmark, 2730
        • Recruiting
        • Herlev and Gentofte Hospital ( Site 3301)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 38 68 38 68
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Recruiting
        • Aalborg Universitetshospital, Syd ( Site 3302)
        • Contact:
          • Study Coordinator
          • Phone Number: (+45) 97 66 14 14
    • Syddanmark
      • Odense, Syddanmark, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital ( Site 3300)
        • Contact:
          • Study Coordinator
          • Phone Number: 0045 22314446
  • France
      • Paris, France, 75010
        • Recruiting
        • Hôpital Saint-Louis ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: 33142494949
    • Alpes-Maritimes
      • Nice cedex 3, Alpes-Maritimes, France, 06200
        • Recruiting
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 1211)
        • Contact:
          • Study Coordinator
          • Phone Number: +33492036667
    • Cote-d Or
      • Dijon, Cote-d Or, France, 21079
        • Recruiting
        • Centre Georges François Leclerc ( Site 1210)
        • Contact:
          • Study Coordinator
          • Phone Number: 33380737506
    • Doubs
      • Besançon, Doubs, France, 25030
        • Recruiting
        • CHU Besançon ( Site 1209)
        • Contact:
          • Study Coordinator
          • Phone Number: 33381218097
    • Gironde
      • Bordeaux, Gironde, France, 33075
        • Recruiting
        • CHU de Bordeaux Hop St ANDRE-Service de Dermatologie ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: 33556794705
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35042
        • Recruiting
        • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1206)
        • Contact:
          • Study Coordinator
          • Phone Number: 33299253196
    • Nord
      • Lille, Nord, France, 59037
        • Recruiting
        • Hopital Claude Huriez - CHU de Lille ( Site 1207)
        • Contact:
          • Study Coordinator
          • Phone Number: 33320444193
    • Rhone
      • Pierre-Bénite, Rhone, France, 69310
        • Recruiting
        • centre hospitalier lyon sud-Service de dermatologie ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: 33478861679
    • Somme
      • Amiens, Somme, France, 80054
        • Recruiting
        • CHU d'Amiens-Picardie - Hôpital Sud-Dermatologie ( Site 1208)
        • Contact:
          • Study Coordinator
          • Phone Number: 33322455843
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Recruiting
        • Gustave Roussy-Dermatologie ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: 33142114210
  • Germany
      • Berlin, Germany, 10115
        • Recruiting
        • Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +4930450518002
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitaetsklinikum Hamburg-Eppendorf ( Site 1309)
        • Contact:
          • Study Coordinator
          • Phone Number: 004915222873742
    • Baden-Wurttemberg
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • Recruiting
        • Universitätsmedizin Mannheim ( Site 1305)
        • Contact:
          • Study Coordinator
          • Phone Number: 496213834461
    • Bayern
      • Augsburg, Bayern, Germany, 86156
        • Recruiting
        • Universitaetsklinikum Augsburg ( Site 1312)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 821 400 7401
      • München, Bayern, Germany, 80337
        • Recruiting
        • Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 1315)
        • Contact:
          • Study Coordinator
          • Phone Number: +4989440056065
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18057
        • Recruiting
        • Universitätsmedizin Rostock-Klinik und Poliklinik für Dermatologie und Venerologie ( Site 1310)
        • Contact:
          • Study Coordinator
          • Phone Number: 0049381494149742
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37075
        • Recruiting
        • Universitätsmedizin Göttingen - Georg-August-Universität-Dermatology ( Site 1308)
        • Contact:
          • Study Coordinator
          • Phone Number: +495513966410
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: 492017232431
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • Recruiting
        • Universitaetsklinikum Koeln ( Site 1307)
        • Contact:
          • Study Coordinator
          • Phone Number: 4922147842558
      • Minden, Nordrhein-Westfalen, Germany, 32429
        • Recruiting
        • Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: 495717094501
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Recruiting
        • Universitaetsklinikum des Saarlandes ( Site 1313)
        • Contact:
          • Study Coordinator
          • Phone Number: 06841 16 23840
    • Thuringen
      • Gera, Thuringen, Germany, 07548
        • Recruiting
        • SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1306)
        • Contact:
          • Study Coordinator
          • Phone Number: 493658287758
  • Greece
      • Thessaloniki, Greece, 57001
        • Recruiting
        • European Interbalkan Medical Center-Oncology Department ( Site 3702)
        • Contact:
          • Study Coordinator
          • Phone Number: 306942608228
    • Attiki
      • Athens, Attiki, Greece, 115 26
        • Recruiting
        • General Hospital of Athens "Laiko"-First Department of Internal Medicine ( Site 3700)
        • Contact:
          • Study Coordinator
          • Phone Number: 00306944681159
      • Neo Faliro, Attiki, Greece, 185 47
        • Recruiting
        • Metropolitan Hospital-A' Oncology Dpt ( Site 3701)
        • Contact:
          • Study Coordinator
          • Phone Number: 306944534944
    • Kentriki Makedonia
      • Thessaloniki, Kentriki Makedonia, Greece, 546 22
        • Recruiting
        • Bioclinic Thessalonikis Private Clinic Single Member S.A.-Oncology ( Site 3703)
        • Contact:
          • Study Coordinator
          • Phone Number: 306944189715
  • Israel
      • Afula, Israel, 1834111
        • Recruiting
        • Emek Medical Center ( Site 2003)
        • Contact:
          • Study Coordinator
          • Phone Number: 97246495723
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center ( Site 2004)
        • Contact:
          • Study Coordinator
          • Phone Number: 97226776781
      • Petah Tikva, Israel, 4941 492
        • Recruiting
        • Rabin Medical Center ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-3-9378077
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: 97235302243
  • Italy
      • Milano, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia IRCCS ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 02 94372.754
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi
        • Contact:
          • Study Coordinator
          • Phone Number: 390815903431
    • Lombardia
      • Milan, Lombardia, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: 390223902557
    • Toscana
      • Siena, Toscana, Italy, 53100
        • Recruiting
        • Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: 390577586335
    • Umbria
      • Perugia, Umbria, Italy, 06129
        • Recruiting
        • AO Santa Maria della Misericordia ( Site 1403)
        • Contact:
          • Study Coordinator
          • Phone Number: 00393386605619
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Harbour Cancer & Wellness ( Site 1500)
        • Contact:
          • Study Coordinator
          • Phone Number: 6421783590
    • Wellington
      • Newtown, Wellington, New Zealand, 6021
        • Recruiting
        • Capital, Coast and Hutt Valley District - Wellington Regional Hospital ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: 64275575914
  • Poland
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2908)
        • Contact:
          • Study Coordinator
          • Phone Number: +48523743109
    • Mazowieckie
      • Siedlce, Mazowieckie, Poland, 08-110
        • Recruiting
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2903)
        • Contact:
          • Study Coordinator
          • Phone Number: 48698826497
      • Warszawa, Mazowieckie, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
        • Contact:
          • Study Coordinator
          • Phone Number: 48226439375
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-027
        • Recruiting
        • Bialostockie Centrum Onkologii ( Site 2905)
        • Contact:
          • Study Coordinator
          • Phone Number: +48856784153
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site
        • Contact:
          • Study Coordinator
          • Phone Number: 48583493190
    • Slaskie
      • Gliwice, Slaskie, Poland, 44-101
        • Recruiting
        • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2907)
        • Contact:
          • Study Coordinator
          • Phone Number: 48784981888
    • Swietokrzyskie
      • Kielce, Swietokrzyskie, Poland, 25-734
        • Recruiting
        • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch
        • Contact:
          • Study Coordinator
          • Phone Number: +48604675789
  • Portugal
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3604)
        • Contact:
          • Study Coordinator
          • Phone Number: 351225084000
    • Lisboa
      • Lisbon, Lisboa, Portugal, 1649-035
        • Recruiting
        • Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 3603)
        • Contact:
          • Study Coordinator
          • Phone Number: +351 217 805 000
      • Lisbon, Lisboa, Portugal, 1449-005
        • Recruiting
        • Centro Hospitalar de Lisboa Ocidental - Hospital De Sao Francisco Xavier ( Site 3602)
        • Contact:
          • Study Coordinator
          • Phone Number: 966606539
      • Lisbon, Lisboa, Portugal, 1099-023
        • Recruiting
        • Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3601)
        • Contact:
          • Study Coordinator
          • Phone Number: 351217805000
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
        • Recruiting
        • Medical Oncology Centre of Rosebank ( Site 4106)
        • Contact:
          • Study Coordinator
          • Phone Number: +27118804222
      • Pretoria, Gauteng, South Africa, 0040
        • Recruiting
        • Wilgers Oncology Centre ( Site 4103)
        • Contact:
          • Study Coordinator
          • Phone Number: +27128072744
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7570
        • Recruiting
        • Cape Town Oncology Trials ( Site 4100)
        • Contact:
          • Study Coordinator
          • Phone Number: 27219443832
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: 349327460004350
    • Cataluna
      • Barcelona, Cataluna, Spain, 08036
        • Recruiting
        • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
        • Contact:
          • Study Coordinator
          • Phone Number: 34932275402
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Recruiting
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1603)
        • Contact:
          • Study Coordinator
          • Phone Number: 34914521987
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: (+34) 913368263
    • Malaga
      • Málaga, Malaga, Spain, 29011
        • Recruiting
        • H.R.U Málaga - Hospital General-Oncology ( Site 1605)
        • Contact:
          • Study Coordinator
          • Phone Number: 34951291425
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Recruiting
        • HOSPITAL CLINICO DE VALENCIA ( Site 1604)
        • Contact:
          • Study Coordinator
          • Phone Number: 34961973500441687
  • Sweden
    • Skane Lan
      • Lund, Skane Lan, Sweden, 22185
        • Recruiting
        • Skånes Universitetssjukhus Lund ( Site 3201)
        • Contact:
          • Study Coordinator
          • Phone Number: 4646177520
    • Vastra Gotalands Lan
      • Gothenburg, Vastra Gotalands Lan, Sweden, 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset ( Site 3200)
        • Contact:
          • Study Coordinator
          • Phone Number: 46700206198
  • Switzerland
    • Grisons
      • Chur, Grisons, Switzerland, 7000
        • Recruiting
        • Kantonsspital Graubünden-Medizin ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: +41 81 256 66 46
    • Zurich
      • Zürich Flughafen, Zurich, Switzerland, 8058
        • Recruiting
        • UniversitätsSpital Zürich-Dermatology ( Site 1700)
        • Contact:
          • Study Coordinator
          • Phone Number: 41442552588
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung ( Site 4000)
        • Contact:
          • Study Coordinator
          • Phone Number: +88677317123
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital-Clinical Trial Center ( Site 4004)
        • Contact:
          • Study Coordinator
          • Phone Number: 886623535354559
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital ( Site 4001)
        • Contact:
          • Study Coordinator
          • Phone Number: 886223123456
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch ( Site 4003)
        • Contact:
          • Study Coordinator
          • Phone Number: 886332812008475
  • Turkey
      • Ankara, Turkey, 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri ( Site 3006)
        • Contact:
          • Study Coordinator
          • Phone Number: 905326880089
      • Ankara, Turkey, 06520
        • Recruiting
        • Memorial Ankara Hastanesi-Medical Oncology ( Site 3010)
        • Contact:
          • Study Coordinator
          • Phone Number: 905067521275
      • Ankara, Turkey, 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 3002)
        • Contact:
          • Study Coordinator
          • Phone Number: 905052933234
      • Istanbul, Turkey, 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3003)
        • Contact:
          • Study Coordinator
          • Phone Number: 00905063509061
      • Istanbul, Turkey, 34303
        • Recruiting
        • Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 3008)
        • Contact:
          • Study Coordinator
          • Phone Number: 90 505 746 51 78
    • Izmir
      • Izmir, Karsiyaka, Izmir, Turkey, 009035575
        • Recruiting
        • I.E.U. Medical Point Hastanesi-Oncology ( Site 3005)
        • Contact:
          • Study Coordinator
          • Phone Number: +905052642353
  • United Kingdom
      • Manchester, United Kingdom, m20 4bx
        • Recruiting
        • The Christie NHS Foundation Trust ( Site 1814)
        • Contact:
          • Study Coordinator
          • Phone Number: 4401614463745
    • Bristol, City Of
      • Bristol, Bristol, City Of, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Haematology and Oncology Centre ( Site 1811)
        • Contact:
          • Study Coordinator
          • Phone Number: 07896419216
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital ( Site 1800)
        • Contact:
          • Study Coordinator
          • Phone Number: 441223274401
    • England
      • Cringleford, England, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk and Norwich University Hospitals NHS Foundation Trust ( Site 1813)
        • Contact:
          • Study Coordinator
          • Phone Number: 01603 288955
    • Kensington And Chelsea
      • London, Kensington And Chelsea, United Kingdom, SW3 6JJ
        • Recruiting
        • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: 442078082132
    • London, City Of
      • London, London, City Of, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospital ( Site 1807)
        • Contact:
          • Study Coordinator
          • Phone Number: 4402034475085
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH4 2XU
        • Recruiting
        • Western General Hospital ( Site 1806)
        • Contact:
          • Study Coordinator
          • Phone Number: 0131537100 ext 31035
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Recruiting
        • The Churchill Hospital ( Site 1805)
        • Contact:
          • Study Coordinator
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group ( Site 1943)
        • Contact:
          • Study Coordinator
          • Phone Number: 479-587-1700
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-794-6892
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Medical Center at Mission Bay ( Site 1929)
        • Contact:
          • Study Coordinator
          • Phone Number: 415-353-7392
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale-New Haven Hospital-Yale Cancer Center ( Site 1933)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-671-5509
    • Florida
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Cancer Institute ( Site 1937)
        • Contact:
          • Study Coordinator
          • Phone Number: 321-841-8470
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950)
        • Contact:
          • Study Coordinator
          • Phone Number: 770-281-5100
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa-Holden Comprehensive Cancer Center ( Site 1935)
        • Contact:
          • Study Coordinator
          • Phone Number: 319-356-2324
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912)
        • Contact:
          • Study Coordinator
          • Phone Number: 410-583-2970
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan ( Site 1932)
        • Contact:
          • Study Coordinator
          • Phone Number: 616-954-9800
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944)
        • Contact:
          • Study Coordinator
          • Phone Number: 551-996-5814
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Atlantic Health System ( Site 1925)
        • Contact:
          • Study Coordinator
          • Phone Number: 973-971-7111
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958)
        • Contact:
          • Study Coordinator
          • Phone Number: 917-613-8046
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health-Perlmutter Cancer Center ( Site 1917)
        • Contact:
          • Study Coordinator
          • Phone Number: 917-613-8046
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center ( Site 1914)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-888-4589
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Institute ( Site 1911)
        • Contact:
          • Study Coordinator
          • Phone Number: 919-684-8239
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 1905)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-796-5159
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center ( Site 1909)
        • Contact:
          • Study Coordinator
          • Phone Number: 412-623-4511
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Recruiting
        • Sanford Cancer Center ( Site 1951)
        • Contact:
          • Study Coordinator
          • Phone Number: 605-328-8000
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Oncology - Austin ( Site 1903)
        • Contact:
          • Study Coordinator
          • Phone Number: 512-427-9400
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - Dallas (Sammons) ( Site 1902)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-370-1900
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute ( Site 1900)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-615-8535
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center ( Site 1901)
        • Contact:
          • Study Coordinator
          • Phone Number: 206-606-6326

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: V940 + Pembrolizumab
Participants receive up to 9 doses of V940 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: V940
IM injection
Other Names:
  • mRNA-4157
  • Individualized neoantigen therapy
Active Comparator: Placebo + Pembrolizumab
Participants receive up to 9 doses of dose matched placebo to V940 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 (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V940-001 (Other Identifier: Merck)
  • 2023-503652-27-00 (Other Identifier: EU CT number)
  • jRCT2041230169 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/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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