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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)
Sponsor: Merck Sharp & Dohme LLC
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1594
Start Date
2023-01-19
Completion Date
2025-09-26
Last Updated
2026-08-18
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab/Vibostolimab
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 17 administrations
Pembrolizumab
Pembrolizumab 25 mg/mL administered as IV infusion for up to 17 administrations
Locations (205)
Moores Cancer Center ( Site 0116)
La Jolla, California, United States
The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123)
Los Angeles, California, United States
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131)
Los Angeles, California, United States
California Pacific Medical Center - Pacific Campus ( Site 0111)
San Francisco, California, United States
UCSF Medical Center at Mission Bay ( Site 0130)
San Francisco, California, United States
The Melanoma & Skin Cancer Institute ( Site 0120)
Englewood, Colorado, United States
Georgetown University Medical Center ( Site 0144)
Washington D.C., District of Columbia, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110)
Miami, Florida, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 0124)
Tampa, Florida, United States
Northwestern Memorial Hospital ( Site 0109)
Chicago, Illinois, United States
Advocate Medical Group-Oncology ( Site 0102)
Park Ridge, Illinois, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 0107)
Iowa City, Iowa, United States
Henry Ford Hospital ( Site 0133)
Detroit, Michigan, United States
Comprehensive Cancer Centers of Nevada ( Site 0142)
Las Vegas, Nevada, United States
R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0132)
Lake Success, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0146)
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113)
New York, New York, United States
Icahn School of Medicine at Mount Sinai ( Site 0118)
New York, New York, United States
Weill Cornell Medical College ( Site 0115)
New York, New York, United States
Levine Cancer Institute ( Site 0138)
Charlotte, North Carolina, United States
Sanford Fargo Medical Center ( Site 0127)
Fargo, North Dakota, United States
Children's Hospital of Pittsburgh ( Site 0141)
Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center ( Site 0135)
Pittsburgh, Pennsylvania, United States
Sanford Cancer Center ( Site 0125)
Sioux Falls, South Dakota, United States
The West Clinic, PLLC dba West Cancer Center ( Site 0119)
Germantown, Tennessee, United States
St. Jude Children's Research Hospital ( Site 0106)
Memphis, Tennessee, United States
Vanderbilt University Medical Center ( Site 0139)
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center ( Site 0145)
Houston, Texas, United States
Inova Schar Cancer Institute ( Site 0103)
Fairfax, Virginia, United States
University of Wisconsin Hospital and Clinics ( Site 0108)
Madison, Wisconsin, United States
Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0204)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming-Alexander Fleming ( Site 0209)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0200)
Buenos Aires, Buenos Aires F.D., Argentina
Instituto de Oncología de Rosario ( Site 0206)
Rosario, Santa Fe Province, Argentina
Sanatorio Finochietto ( Site 0212)
Buenos Aires, Argentina
Clinica Adventista Belgrano-Oncology ( Site 0211)
CABA, Argentina
Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464)
Blacktown, New South Wales, Australia
Calvary Mater Newcastle-Medical Oncology ( Site 1462)
Waratah, New South Wales, Australia
Melanoma Institute Australia-Clinical Trials Unit ( Site 1450)
Wollstonecraft, New South Wales, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
Brisbane, Queensland, Australia
Cairns Hospital-Clinical Research Unit ( Site 1458)
Cairns, Queensland, Australia
Gallipoli Medical Research Ltd-GMRF CTU ( Site 1451)
Greenslopes, Queensland, Australia
Tasman Oncology Research ( Site 1456)
Southport, Queensland, Australia
Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457)
Adelaide, South Australia, Australia
Icon Cancer Centre Hobart ( Site 1465)
Hobart, Tasmania, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455)
Melbourne, Victoria, Australia
One Clinical Research ( Site 1460)
Nedlands, Western Australia, Australia
Universitätsklinikum St. Pölten-Department of Dermatology ( Site 0606)
Sankt Pölten, Lower Austria, Austria
Medizinische Universität Wien-Department of Dermatology ( Site 0600)
Vienna, State of Vienna, Austria
Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0601)
Graz, Styria, Austria
Medizinische Universitaet Innsbruck-Univ Klinik für Dermatologie, Venerologie und Allergologie ( Sit
Innsbruck, Tyrol, Austria
Ordensklinikum Linz GmbH Elisabethinen-Dermatologie ( Site 0602)
Linz, Upper Austria, Austria
Uniklinikum Salzburg-Department of Dermatology and Allergology ( Site 0604)
Salzburg, Austria
GZA Ziekenhuizen campus Sint-Augustinus ( Site 0655)
Wilrijk, Antwerpen, Belgium
Cliniques universitaires Saint-Luc ( Site 0652)
Brussels, Bruxelles-Capitale, Region de, Belgium
Jessa Ziekenhuis ( Site 0656)
Hasselt, Limburg, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0653)
Yvoir, Namur, Belgium
VITAZ-Medical Oncology ( Site 0654)
Sint-Niklaas, Oost-Vlaanderen, Belgium
UZ Leuven-General Medical Oncology ( Site 0650)
Leuven, Vlaams-Brabant, Belgium
Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 0256)
Belo Horizonte, Minas Gerais, Brazil
Hospital de Cancer de Londrina-Clinical Research Unit ( Site 0252)
Londrina, Paraná, Brazil
Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 0259)
Passo Fundo, Rio Grande do Sul, Brazil
ANIMI - Unidade de Tratamento Oncologico ( Site 0255)
Lages, Santa Catarina, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia ( Site 0262)
Santo André, São Paulo, Brazil
A. C. Camargo Cancer Center ( Site 0258)
São Paulo, Brazil
The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0004)
Ottawa, Ontario, Canada
Sunnybrook Research Institute ( Site 0003)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0006)
Toronto, Ontario, Canada
Oncocentro Valdivia ( Site 0307)
Valdivia, Los Ríos Region, Chile
FALP-UIDO ( Site 0303)
Santiago, Region M. de Santiago, Chile
Oncovida ( Site 0304)
Santiago, Region M. de Santiago, Chile
Clínica UC San Carlos de Apoquindo ( Site 0305)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 0302)
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 0300)
Viña del Mar, Valparaiso, Chile
Bradford Hill Norte ( Site 0308)
Antofagasta, Chile
Beijing Ji Shui Tan Hospital ( Site 1657)
Beijing, Beijing Municipality, China
Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 1650)
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital ( Site 1651)
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital ( Site 1659)
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center-melanoma ( Site 1655)
Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 1668)
Nanning, Guangxi, China
Fourth Hospital of Hebei Medical University ( Site 1669)
Shijiazhuang, Hebei, China
The Third Hospital of Zhengzhou-Oncology ( Site 1653)
Zhengzhou, Henan, China
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 1664)
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University-Oncology ( Site 1673)
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
Nanjing, Jiangsu, China
Jiangsu Province Hospital-Oncology Department ( Site 1663)
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University ( Site 1652)
Nanchang, Jiangxi, China
The First Hospital of Jilin University-Oncology ( Site 1665)
Changchun, Jilin, China
Fudan University Shanghai Cancer Center ( Site 1658)
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital ( Site 1660)
Taiyuan, Shanxi, China
West China Hospital, Sichuan University-Head and Neck Oncology ( Site 1667)
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital-Biotherapy ( Site 1671)
Tianjin, Tianjin Municipality, China
Xinjiang Medical University Cancer Hospital - Urumqi-Bone and Soft Tissue Department ( Site 1674)
Ürümqi, Xinjiang, China
Yunnan Province Cancer Hospital-Biotherapy Center ( Site 1666)
Kunming, Yunnan, China
Zhejiang Cancer Hospital-Oncology ( Site 1661)
Hangzhou, Zhejiang, China
Instituto de Cancerología ( Site 0356)
Medellín, Antioquia, Colombia
Fundación Colombiana de Cancerología Clínica Vida ( Site 0355)
Medellín, Antioquia, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0358)
Bogotá, Bogota D.C., Colombia
Mediservis del Tolima IPS S.A.S ( Site 0357)
Ibague, Tolima Department, Colombia
Fundación Valle del Lili ( Site 0352)
Cali, Valle del Cauca Department, Colombia
Centre Hospitalier de Valence-Service de Dermatologie ( Site 0702)
Valence, Drome, France
Hopital Claude Huriez - CHU de Lille-Clinique de Dermatologie ( Site 0700)
Lille, Hauts-de-France, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Onco-Dermatology ( Site 0707)
Nantes, Loire-Atlantique, France
Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 0706)
Saint-Herblain, Loire-Atlantique, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Hospitalier de Pau ( Site 0708)
Pau, Pyrenees-Atlantiques, France
centre hospitalier lyon sud-Service de dermatologie ( Site 0714)
Pierre-Bénite, Rhone, France
Gustave Roussy-Dermatologie ( Site 0713)
Villejuif, Val-de-Marne, France
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0711)
Paris, France
Universitaetsklinikum Heidelberg ( Site 0765)
Heidelberg, Baden-Wurttemberg, Germany
Universitätsmedizin Mannheim ( Site 0751)
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen-Hautklinik ( Site 0750)
Erlangen, Bavaria, Germany
Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 0757)
München, Bavaria, Germany
Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0754)
Buxtehude, Lower Saxony, Germany
Medizinische Hochschule Hannover ( Site 0758)
Hanover, Lower Saxony, Germany
Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0761)
Essen, North Rhine-Westphalia, Germany
Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 0759)
Minden, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0766)
Dresden, Saxony, Germany
Universitätsklinikum Leipzig ( Site 0762)
Leipzig, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel-Hautklinik ( Site 0767)
Kiel, Schleswig-Holstein, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 0756)
Berlin, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0752)
Hamburg, Germany
Artemis hospital ( Site 1551)
Gurugram, Haryana, India
Tata Memorial Hospital-Medical Oncology ( Site 1550)
Mumbai, Maharashtra, India
All India Institute of Medical Sciences-Medical oncology ( Site 1552)
New Delhi, National Capital Territory of Delhi, India
St. James's Hospital-Cancer clinical trials office ( Site 0900)
Dublin, Ireland
Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 0902)
Dublin, Ireland
Emek Medical Center-oncology ( Site 0952)
Afula, Israel
Soroka Medical Center ( Site 0953)
Beersheba, Israel
Rambam Health Care Campus-Oncology Division ( Site 0955)
Haifa, Israel
Hadassah Medical Center ( Site 0951)
Jerusalem, Israel
Rabin Medical Center-Oncology ( Site 0954)
Petah Tikva, Israel
Sheba Medical Center-ONCOLOGY ( Site 0950)
Ramat Gan, Israel
Instituto Tumori Giovanni Paolo II ( Site 1003)
Bari, Apulia, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1004)
Meldola, Emilia-Romagna, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1000)
Milan, Lombardy, Italy
A.O.U. Policlinico Paolo Giaccone-Depatment of Discipline Chirurgiche, Oncologiche e Stomatologiche
Palermo, Sicily, Italy
Azienda Ospedaliero Universitaria Senese ( Site 1005)
Siena, Tuscany, Italy
AO Santa Maria della Misericordia ( Site 1006)
Perugia, Umbria, Italy
Istituto Europeo di Oncologia IRCCS ( Site 1008)
Milan, Italy
Azienda Ospedaliero Universitaria ( Site 1002)
Modena, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1001)
Naples, Italy
Nagoya University Hospital ( Site 1753)
Nagoya, Aichi-ken, Japan
Sapporo Medical University Hospital ( Site 1755)
Sapporo, Hokkaido, Japan
Niigata Cancer Center Hospital ( Site 1751)
Niigata, Niigata, Japan
Shizuoka Cancer Center ( Site 1752)
Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital ( Site 1750)
Chuo-ku, Tokyo, Japan
Osaka International Cancer Institute ( Site 1754)
Osaka, Japan
Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1501)
Tauranga, Bay of Plenty, New Zealand
New Zealand Clinical Research (Christchurch) ( Site 1509)
Christchurch, Canterbury, New Zealand
P3 Research - Palmerston North ( Site 1510)
Palmerston North, Manawatu-Wanganui, New Zealand
Dunedin Hospital ( Site 1511)
Dunedin, Otago, New Zealand
Harbour Cancer & Wellness ( Site 1508)
Auckland, New Zealand
Szpital Kliniczny im. H. Swiecickiego nr 2-Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej (
Poznan, Greater Poland Voivodeship, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1061)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Pratia MCM Krakow ( Site 1053)
Krakow, Lesser Poland Voivodeship, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1058)
Siedlce, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Warsaw, Masovian Voivodeship, Poland
Bialostockie Centrum Onkologii ( Site 1065)
Bialystok, Podlaskie Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site
Gdansk, Pomeranian Voivodeship, Poland
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1064)
Słupsk, Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1056)
Gliwice, Silesian Voivodeship, Poland
Zachodniopomorskie Centrum Onkologii ( Site 1063)
Szczecin, West Pomeranian Voivodeship, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1054)
Kielce, Świętokrzyskie Voivodeship, Poland
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 1161)
Port Elizabeth, Eastern Cape, South Africa
Medical Oncology Centre of Rosebank ( Site 1160)
Johannesburg, Gauteng, South Africa
Wilgers Oncology Centre ( Site 1154)
Pretoria, Gauteng, South Africa
Curo Oncology ( Site 1158)
Pretoria, Gauteng, South Africa
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1152)
Pretoria, Gauteng, South Africa
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 1151)
Sandton, Gauteng, South Africa
The Oncology Centre ( Site 1157)
Durban, KwaZulu-Natal, South Africa
Abraham Oncology ( Site 1150)
Richards Bay, KwaZulu-Natal, South Africa
Cape Town Oncology Trials ( Site 1155)
Cape Town, Western Cape, South Africa
Cancercare Rondebosch Oncology-Clinical trials ( Site 1159)
Rondebosch, Western Cape, South Africa
Seoul National University Hospital-Oncology ( Site 1600)
Seoul, South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1601)
Seoul, South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 1602)
Seoul, South Korea
Institut Català d'Oncologia - L'Hospitalet ( Site 1202)
L'Hospitalet de Llobregat, Barcelona, Spain
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1203)
Doniostia - San Sebastian, Gipuzkoa, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1204)
Madrid, Madrid, Comunidad de, Spain
H.R.U Málaga - Hospital General-Oncology ( Site 1201)
Málaga, Malaga, Spain
Hospital General Universitario de Valencia ( Site 1200)
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1205)
Seville, Spain
Länssjukhuset Ryhov-Onkologkliniken ( Site 1253)
Jönköping, Jönköping County, Sweden
Karolinska Universitetssjukhuset Solna ( Site 1252)
Stockholm, Stockholm County, Sweden
University Hospital Basel ( Site 1303)
Basel, Canton of Basel-City, Switzerland
Inselspital Bern ( Site 1301)
Bern, Canton of Bern, Switzerland
Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1307)
Geneva, Canton of Geneva, Switzerland
CHUV (centre hospitalier universitaire vaudois) ( Site 1304)
Lausanne, Canton of Vaud, Switzerland
UniversitätsSpital Zürich-Dermatology ( Site 1300)
Zürich Flughafen, Canton of Zurich, Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 1308)
Bellinzona, Canton Ticino, Switzerland
Hôpital de Sion ( Site 1305)
Sion, Valais, Switzerland
Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 1306)
Sankt Gallen, Switzerland
Ankara City Hospital-Medical Oncology ( Site 1357)
Çankaya, Ankara, Turkey (Türkiye)
I.E.U. Medical Point Hastanesi-Oncology ( Site 1360)
Izmir, Karsiyaka, İzmir, Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 1363)
Ankara, Turkey (Türkiye)
Liv Hospital Ankara-Oncology ( Site 1353)
Ankara, Turkey (Türkiye)
Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1355)
Antalya, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1358)
Istanbul, Turkey (Türkiye)
Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1361)
Mersin, Turkey (Türkiye)
Ondokuz Mayıs Universitesi-Oncology department ( Site 1359)
Samsun, Turkey (Türkiye)
Addenbrooke's Hospital ( Site 1400)
Cambridge, Cambridgeshire, United Kingdom
University College London Hospital ( Site 1405)
London, England, United Kingdom
Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1401)
London, London, City of, United Kingdom