A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)

October 3, 2025 updated by: Merck Sharp & Dohme LLC

A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010)

The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With Amendment 4, participants will discontinue treatment with pembrolizumab/vibostolimab.

The protocol-specified futility analysis of the primary outcome measure was completed with a data cut-off of 06-Mar-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure. Per protocol, 192 participants enrolled after the primary completion date and will be analyzed in the End of Trial analysis.

Study Type

Interventional

Enrollment (Actual)

1594

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, C1187AAN
        • Sanatorio Finochietto ( Site 0212)
      • CABA, Argentina, C1430EGF
        • Clinica Adventista Belgrano-Oncology ( Site 0211)
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1027AAP
        • Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0204)
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Instituto Alexander Fleming-Alexander Fleming ( Site 0209)
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1431FWO
        • Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0200)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000KZE
        • Instituto de Oncología de Rosario ( Site 0206)
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464)
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle-Medical Oncology ( Site 1462)
      • Wollstonecraft, New South Wales, Australia, 2065
        • Melanoma Institute Australia-Clinical Trials Unit ( Site 1450)
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
      • Cairns, Queensland, Australia, 4870
        • Cairns Hospital-Clinical Research Unit ( Site 1458)
      • Greenslopes, Queensland, Australia, 4120
        • Gallipoli Medical Research Ltd-GMRF CTU ( Site 1451)
      • Southport, Queensland, Australia, 4215
        • Tasman Oncology Research ( Site 1456)
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457)
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Icon Cancer Centre Hobart ( Site 1465)
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455)
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • One Clinical Research ( Site 1460)
  • Austria
      • Salzburg, Austria, 5020
        • Uniklinikum Salzburg-Department of Dermatology and Allergology ( Site 0604)
    • Lower Austria
      • Sankt Pölten, Lower Austria, Austria, 3100
        • Universitätsklinikum St. Pölten-Department of Dermatology ( Site 0606)
    • Styria
      • Graz, Styria, Austria, 8036
        • Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0601)
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medizinische Universitaet Innsbruck-Univ Klinik für Dermatologie, Venerologie und Allergologie ( Sit
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Ordensklinikum Linz GmbH Elisabethinen-Dermatologie ( Site 0602)
    • Vienna
      • Vienna, Vienna, Austria, 1090
        • Medizinische Universität Wien-Department of Dermatology ( Site 0600)
  • Belgium
    • Antwerpen
      • Wilrijk, Antwerpen, Belgium, 2610
        • GZA Ziekenhuizen campus Sint-Augustinus ( Site 0655)
    • Bruxelles-Capitale, Region de
      • Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
        • Cliniques universitaires Saint-Luc ( Site 0652)
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Jessa Ziekenhuis ( Site 0656)
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0653)
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, B-9100
        • VITAZ-Medical Oncology ( Site 0654)
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven-General Medical Oncology ( Site 0650)
  • Brazil
      • São Paulo, Brazil, 01509-010
        • A. C. Camargo Cancer Center ( Site 0258)
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130090
        • Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 0256)
    • Paraná
      • Londrina, Paraná, Brazil, 86015-520
        • Hospital de Cancer de Londrina-Clinical Research Unit ( Site 0252)
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-080
        • Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 0259)
    • Santa Catarina
      • Lages, Santa Catarina, Brazil, 88501001
        • ANIMI - Unidade de Tratamento Oncologico ( Site 0255)
    • São Paulo
      • Santo André, São Paulo, Brazil, 09060-870
        • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia ( Site 0262)
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0004)
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre ( Site 0006)
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute ( Site 0003)
  • Chile
      • Antofagasta, Chile, 1240000
        • Bradford Hill Norte ( Site 0308)
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5112129
        • Oncocentro Valdivia ( Site 0307)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • FALP-UIDO ( Site 0303)
      • Santiago, Region M. de Santiago, Chile, 7510032
        • Oncovida ( Site 0304)
      • Santiago, Region M. de Santiago, Chile, 7620002
        • Clínica UC San Carlos de Apoquindo ( Site 0305)
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Bradfordhill-Clinical Area ( Site 0302)
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile, 2520598
        • ONCOCENTRO APYS-ACEREY ( Site 0300)
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100035
        • Beijing Ji Shui Tan Hospital ( Site 1657)
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 1650)
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Chongqing University Cancer Hospital ( Site 1651)
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Provincial Cancer Hospital ( Site 1659)
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center-melanoma ( Site 1655)
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Guangxi Medical University Affiliated Tumor Hospital ( Site 1668)
    • Hebei
      • Shijiazhuang, Hebei, China, 050035
        • Fourth Hospital of Hebei Medical University ( Site 1669)
    • Henan
      • Zhengzhou, Henan, China, 450001
        • The Third Hospital of Zhengzhou-Oncology ( Site 1653)
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital Cancer Center-Cancer Center ( Site 1664)
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University-Oncology ( Site 1673)
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital-Oncology Department ( Site 1663)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University ( Site 1652)
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University-Oncology ( Site 1665)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center ( Site 1658)
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Shanxi Bethune Hospital ( Site 1660)
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University-Head and Neck Oncology ( Site 1667)
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Tianjin Medical University Cancer Institute & Hospital-Biotherapy ( Site 1671)
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Xinjiang Medical University Cancer Hospital - Urumqi-Bone and Soft Tissue Department ( Site 1674)
    • Yunnan
      • Kunming, Yunnan, China, 650106
        • Yunnan Province Cancer Hospital-Biotherapy Center ( Site 1666)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital-Oncology ( Site 1661)
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050025
        • Instituto de Cancerología ( Site 0356)
      • Medellín, Antioquia, Colombia, 050030
        • Fundación Colombiana de Cancerología Clínica Vida ( Site 0355)
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 111321
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0358)
    • Tolima Department
      • Ibagué, Tolima Department, Colombia, 730006
        • Mediservis del Tolima IPS S.A.S ( Site 0357)
    • Valle del Cauca Department
      • Santiago de Cali, Valle del Cauca Department, Colombia, 760032
        • Fundación Valle del Lili ( Site 0352)
  • France
      • Paris, France, 75014
        • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0711)
    • Drome
      • Valence, Drome, France, 26953
        • Centre Hospitalier de Valence-Service de Dermatologie ( Site 0702)
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59037
        • Hopital Claude Huriez - CHU de Lille-Clinique de Dermatologie ( Site 0700)
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Onco-Dermatology ( Site 0707)
      • Saint-Herblain, Loire-Atlantique, France, 44805
        • Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 0706)
    • Provence-Alpes-Côte d'Azur Region
      • Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi
    • Pyrenees-Atlantiques
      • Pau, Pyrenees-Atlantiques, France, 64000
        • Centre Hospitalier de Pau ( Site 0708)
    • Rhone
      • Pierre-Bénite, Rhone, France, 69310
        • centre hospitalier lyon sud-Service de dermatologie ( Site 0714)
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Gustave Roussy-Dermatologie ( Site 0713)
  • Germany
      • Berlin, Germany, 10117
        • Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 0756)
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf ( Site 0752)
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Universitaetsklinikum Heidelberg ( Site 0765)
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • Universitätsmedizin Mannheim ( Site 0751)
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Universitaetsklinikum Erlangen-Hautklinik ( Site 0750)
      • München, Bavaria, Germany, 80337
        • Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 0757)
    • Lower Saxony
      • Buxtehude, Lower Saxony, Germany, 21614
        • Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0754)
      • Hanover, Lower Saxony, Germany, 30625
        • Medizinische Hochschule Hannover ( Site 0758)
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0761)
      • Minden, North Rhine-Westphalia, Germany, 32429
        • Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 0759)
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0766)
      • Leipzig, Saxony, Germany, 04103
        • Universitätsklinikum Leipzig ( Site 0762)
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel-Hautklinik ( Site 0767)
  • India
    • Haryana
      • Gurugram, Haryana, India, 122001
        • Artemis hospital ( Site 1551)
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Hospital-Medical Oncology ( Site 1550)
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • All India Institute of Medical Sciences-Medical oncology ( Site 1552)
  • Ireland
      • Dublin, Ireland, D08 E9P6
        • St. James's Hospital-Cancer clinical trials office ( Site 0900)
      • Dublin, Ireland, Dublin 9
        • Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 0902)
  • Israel
      • Afula, Israel, 1834111
        • Emek Medical Center-oncology ( Site 0952)
      • Beersheba, Israel, 8410101
        • Soroka Medical Center ( Site 0953)
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus-Oncology Division ( Site 0955)
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center ( Site 0951)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center-Oncology ( Site 0954)
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center-ONCOLOGY ( Site 0950)
  • Italy
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia IRCCS ( Site 1008)
      • Modena, Italy, 41125
        • Azienda Ospedaliero Universitaria ( Site 1002)
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1001)
    • Apulia
      • Bari, Apulia, Italy, 70124
        • Instituto Tumori Giovanni Paolo II ( Site 1003)
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1004)
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1000)
    • Sicily
      • Palermo, Sicily, Italy, 90129
        • A.O.U. Policlinico Paolo Giaccone-Depatment of Discipline Chirurgiche, Oncologiche e Stomatologiche
    • Tuscany
      • Siena, Tuscany, Italy, 53100
        • Azienda Ospedaliero Universitaria Senese ( Site 1005)
    • Umbria
      • Perugia, Umbria, Italy, 06129
        • AO Santa Maria della Misericordia ( Site 1006)
  • Japan
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute ( Site 1754)
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Nagoya University Hospital ( Site 1753)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital ( Site 1755)
    • Niigata
      • Niigata, Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital ( Site 1751)
    • Shizuoka
      • Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center ( Site 1752)
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital ( Site 1750)
  • New Zealand
      • Auckland, New Zealand, 0627
        • Harbour Cancer & Wellness ( Site 1508)
    • Bay of Plenty
      • Tauranga, Bay of Plenty, New Zealand, 3112
        • Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1501)
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • New Zealand Clinical Research (Christchurch) ( Site 1509)
    • Manawatu-Wanganui
      • Palmerston North, Manawatu-Wanganui, New Zealand, 4414
        • P3 Research - Palmerston North ( Site 1510)
    • Otago
      • Dunedin, Otago, New Zealand, 9016
        • Dunedin Hospital ( Site 1511)
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-780
        • Szpital Kliniczny im. H. Swiecickiego nr 2-Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej (
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1061)
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Pratia MCM Krakow ( Site 1053)
    • Masovian Voivodeship
      • Siedlce, Masovian Voivodeship, Poland, 08-110
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1058)
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-027
        • Bialostockie Centrum Onkologii ( Site 1065)
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site
      • Słupsk, Pomeranian Voivodeship, Poland, 76-200
        • Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1064)
    • Silesian Voivodeship
      • Gliwice, Silesian Voivodeship, Poland, 44-101
        • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1056)
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-730
        • Zachodniopomorskie Centrum Onkologii ( Site 1063)
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1054)
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6055
        • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 1161)
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
        • Medical Oncology Centre of Rosebank ( Site 1160)
      • Pretoria, Gauteng, South Africa, 0040
        • Wilgers Oncology Centre ( Site 1154)
      • Pretoria, Gauteng, South Africa, 0084
        • Curo Oncology ( Site 1158)
      • Pretoria, Gauteng, South Africa, 0181
        • LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1152)
      • Sandton, Gauteng, South Africa, 2196
        • Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 1151)
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4091
        • The Oncology Centre ( Site 1157)
      • Richards Bay, KwaZulu-Natal, South Africa, 3900
        • Abraham Oncology ( Site 1150)
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7570
        • Cape Town Oncology Trials ( Site 1155)
      • Rondebosch, Western Cape, South Africa, 7700
        • Cancercare Rondebosch Oncology-Clinical trials ( Site 1159)
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital-Oncology ( Site 1600)
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1601)
      • Seoul, South Korea, 06351
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 1602)
  • Spain
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1205)
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Institut Català d'Oncologia - L'Hospitalet ( Site 1202)
    • Gipuzkoa
      • Doniostia - San Sebastian, Gipuzkoa, Spain, 20014
        • Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1203)
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1204)
    • Malaga
      • Málaga, Malaga, Spain, 29011
        • H.R.U Málaga - Hospital General-Oncology ( Site 1201)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46014
        • Hospital General Universitario de Valencia ( Site 1200)
  • Sweden
    • Jönköping County
      • Jönköping, Jönköping County, Sweden, 553 05
        • Länssjukhuset Ryhov-Onkologkliniken ( Site 1253)
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 171 64
        • Karolinska Universitetssjukhuset Solna ( Site 1252)
  • Switzerland
      • Sankt Gallen, Switzerland, 9007
        • Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 1306)
    • Canton Ticino
      • Bellinzona, Canton Ticino, Switzerland, 6500
        • Ospedale Regionale Bellinzona e Valli ( Site 1308)
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4056
        • University Hospital Basel ( Site 1303)
    • Canton of Bern
      • Bern, Canton of Bern, Switzerland, 3010
        • Inselspital Bern ( Site 1301)
    • Canton of Geneva
      • Geneva, Canton of Geneva, Switzerland, 1211
        • Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1307)
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Switzerland, 1011
        • CHUV (centre hospitalier universitaire vaudois) ( Site 1304)
    • Canton of Zurich
      • Zürich Flughafen, Canton of Zurich, Switzerland, 8058
        • UniversitätsSpital Zürich-Dermatology ( Site 1300)
    • Valais
      • Sion, Valais, Switzerland, 1951
        • Hôpital de Sion ( Site 1305)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universite Hastaneleri ( Site 1363)
      • Ankara, Turkey (Türkiye), 06680
        • Liv Hospital Ankara-Oncology ( Site 1353)
      • Antalya, Turkey (Türkiye), 07059
        • Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1355)
      • Istanbul, Turkey (Türkiye), 34722
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1358)
      • Mersin, Turkey (Türkiye), 33240
        • Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1361)
      • Samsun, Turkey (Türkiye), 55139
        • Ondokuz Mayıs Universitesi-Oncology department ( Site 1359)
    • Ankara
      • Çankaya, Ankara, Turkey (Türkiye), 06800
        • Ankara City Hospital-Medical Oncology ( Site 1357)
    • İzmir
      • Izmir, Karsiyaka, İzmir, Turkey (Türkiye), 009035575
        • I.E.U. Medical Point Hastanesi-Oncology ( Site 1360)
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital ( Site 1400)
    • England
      • London, England, United Kingdom, NW1 2PG
        • University College London Hospital ( Site 1405)
    • London, City of
      • London, London, City of, United Kingdom, SE1 9RT
        • Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1401)
  • United States
    • California
      • La Jolla, California, United States, 92093-0698
        • Moores Cancer Center ( Site 0116)
      • Los Angeles, California, United States, 90025
        • The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123)
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131)
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center - Pacific Campus ( Site 0111)
      • San Francisco, California, United States, 94158
        • UCSF Medical Center at Mission Bay ( Site 0130)
    • Colorado
      • Englewood, Colorado, United States, 80113
        • The Melanoma & Skin Cancer Institute ( Site 0120)
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University Medical Center ( Site 0144)
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110)
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 0124)
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital ( Site 0109)
      • Park Ridge, Illinois, United States, 60068
        • Advocate Medical Group-Oncology ( Site 0102)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa-Holden Comprehensive Cancer Center ( Site 0107)
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital ( Site 0133)
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada ( Site 0142)
    • New York
      • Lake Success, New York, United States, 11042
        • R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0132)
      • Mineola, New York, United States, 11501
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0146)
      • New York, New York, United States, 10016
        • Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113)
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai ( Site 0118)
      • New York, New York, United States, 10065
        • Weill Cornell Medical College ( Site 0115)
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute ( Site 0138)
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Sanford Fargo Medical Center ( Site 0127)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh ( Site 0141)
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Center ( Site 0135)
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center ( Site 0125)
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The West Clinic, PLLC dba West Cancer Center ( Site 0119)
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital ( Site 0106)
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center ( Site 0139)
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center ( Site 0145)
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute ( Site 0103)
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics ( Site 0108)

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has surgically resected and histologically or pathologically confirmed diagnosis of Stage IIB and IIC (pathological or clinical), III, or IV cutaneous melanoma per the American Joint Committee on Cancer (AJCC) eighth edition guidelines
  • Has not received any prior systemic therapy for melanoma beyond surgical resection
  • Has had no more than 12 weeks between final surgical resection and randomization
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion Criteria:

  • Has ocular, mucosal, or conjunctival melanoma
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
  • Has not adequately recovered from major surgical procedure or has ongoing surgical complications
  • Has received prior radiotherapy within 2 weeks of start of study intervention or has had a history of radiation pneumonitis
  • Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
  • Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has an active infection requiring systemic therapy
  • Has had an allogenic tissue/solid organ transplant

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab/Vibostolimab
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to ~1 year).
Biological: Pembrolizumab/Vibostolimab
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 17 administrations
Other Names:
  • MK-7684A
Active Comparator: Pembrolizumab
Participants receive 200 mg pembrolizumab via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to ~1 year).
Biological: Pembrolizumab
Pembrolizumab 25 mg/mL administered as IV infusion for up to 17 administrations
Other Names:
  • MK-3475
  • KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-Free Survival (RFS)
Time Frame: Up to approximately 13 months
RFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) as assessed by the investigator, or death due to any cause, whichever occurs first. The RFS as assessed by the investigator is presented for all randomized participants. Protocol pre-specified final analysis for this outcome measure was conducted with the primary completion data cut-off.
Up to approximately 13 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experienced at Least One Adverse Event (AE)
Time Frame: Up to approximately 31 months
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.
Up to approximately 31 months
Number of Participants Who Discontinued Study Treatment Due to an AE
Time Frame: Up to approximately 31 months
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.
Up to approximately 31 months

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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.

General Publications

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)

January 19, 2023

Primary Completion (Actual)

March 6, 2024

Study Completion (Actual)

September 26, 2025

Study Registration Dates

First Submitted

December 16, 2022

First Submitted That Met QC Criteria

December 16, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Estimated)

October 15, 2025

Last Update Submitted That Met QC Criteria

October 3, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7684A-010
  • MK-7684A-010 (Other Identifier: MSD)
  • KEYVIBE-010 (Other Identifier: MSD)
  • 2022-501417-31-00 (Registry Identifier: EU CT)
  • jRCT2031230099 (Registry Identifier: jRCT)
  • U1111-1280-3661 (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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