AzTrials
AzTrials

MelanomaPhase 3NCT05665595

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)

A Phase 3 study testing Pembrolizumab/Vibostolimab and Pembrolizumab in people with Melanoma, run by Merck Sharp & Dohme LLC at 205 sites in 26 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Melanoma
What is being tested?
Pembrolizumab/Vibostolimab and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,594 participants
Where
205 sitesin 26 countries
Study dates
19 Jan 2023to 24 Sep 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

205 sites in 26 countries.

205 sites in 26 countries

United States30 sites

  • Levine Cancer Institute ( Site 0138)

    Charlotte, North Carolina, 28204

  • Northwestern Memorial Hospital ( Site 0109)

    Chicago, Illinois, 60611

  • Henry Ford Hospital ( Site 0133)

    Detroit, Michigan, 48202

  • The Melanoma & Skin Cancer Institute ( Site 0120)

    Englewood, Colorado, 80113

  • Inova Schar Cancer Institute ( Site 0103)

    Fairfax, Virginia, 22031

  • Sanford Fargo Medical Center ( Site 0127)

    Fargo, North Dakota, 58102

  • The West Clinic, PLLC dba West Cancer Center ( Site 0119)

    Germantown, Tennessee, 38138

  • University of Texas MD Anderson Cancer Center ( Site 0145)

    Houston, Texas, 77030

  • University of Iowa-Holden Comprehensive Cancer Center ( Site 0107)

    Iowa City, Iowa, 52242

  • Moores Cancer Center ( Site 0116)

    La Jolla, California, 92093-0698

  • R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0132)

    Lake Success, New York, 11042

  • Comprehensive Cancer Centers of Nevada ( Site 0142)

    Las Vegas, Nevada, 89169

  • The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123)

    Los Angeles, California, 90025

  • UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131)

    Los Angeles, California, 90095

  • University of Wisconsin Hospital and Clinics ( Site 0108)

    Madison, Wisconsin, 53792

  • St. Jude Children's Research Hospital ( Site 0106)

    Memphis, Tennessee, 38105

  • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110)

    Miami, Florida, 33136

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0146)

    Mineola, New York, 11501

  • Vanderbilt University Medical Center ( Site 0139)

    Nashville, Tennessee, 37232

  • Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113)

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai ( Site 0118)

    New York, New York, 10029

  • Weill Cornell Medical College ( Site 0115)

    New York, New York, 10065

  • Advocate Medical Group-Oncology ( Site 0102)

    Park Ridge, Illinois, 60068

  • Children's Hospital of Pittsburgh ( Site 0141)

    Pittsburgh, Pennsylvania, 15224

  • UPMC Hillman Cancer Center ( Site 0135)

    Pittsburgh, Pennsylvania, 15232

  • California Pacific Medical Center - Pacific Campus ( Site 0111)

    San Francisco, California, 94115

  • UCSF Medical Center at Mission Bay ( Site 0130)

    San Francisco, California, 94158

  • Sanford Cancer Center ( Site 0125)

    Sioux Falls, South Dakota, 57104

  • Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 0124)

    Tampa, Florida, 33612

  • Georgetown University Medical Center ( Site 0144)

    Washington D.C., District of Columbia, 20007

Other trials in United States

China21 sites

  • Beijing Ji Shui Tan Hospital ( Site 1657)

    Beijing, Beijing Municipality, 100035

  • Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 1650)

    Beijing, Beijing Municipality, 100142

  • The First Hospital of Jilin University-Oncology ( Site 1665)

    Changchun, Jilin, 130021

  • The Second Xiangya Hospital of Central South University-Oncology ( Site 1673)

    Changsha, Hunan, 410011

  • West China Hospital, Sichuan University-Head and Neck Oncology ( Site 1667)

    Chengdu, Sichuan, 610041

  • Chongqing University Cancer Hospital ( Site 1651)

    Chongqing, Chongqing Municipality, 400030

  • Fujian Provincial Cancer Hospital ( Site 1659)

    Fuzhou, Fujian, 350014

  • Sun Yat-sen University Cancer Center-melanoma ( Site 1655)

    Guangzhou, Guangdong, 510060

  • Zhejiang Cancer Hospital-Oncology ( Site 1661)

    Hangzhou, Zhejiang, 310022

  • Yunnan Province Cancer Hospital-Biotherapy Center ( Site 1666)

    Kunming, Yunnan, 650106

  • The First Affiliated Hospital of Nanchang University ( Site 1652)

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (

    Nanjing, Jiangsu, 210000

  • Jiangsu Province Hospital-Oncology Department ( Site 1663)

    Nanjing, Jiangsu, 210029

  • Guangxi Medical University Affiliated Tumor Hospital ( Site 1668)

    Nanning, Guangxi, 530021

  • Fudan University Shanghai Cancer Center ( Site 1658)

    Shanghai, Shanghai Municipality, 200032

  • Fourth Hospital of Hebei Medical University ( Site 1669)

    Shijiazhuang, Hebei, 050035

  • Shanxi Bethune Hospital ( Site 1660)

    Taiyuan, Shanxi, 030032

  • Tianjin Medical University Cancer Institute & Hospital-Biotherapy ( Site 1671)

    Tianjin, Tianjin Municipality

  • Xinjiang Medical University Cancer Hospital - Urumqi-Bone and Soft Tissue Department ( Site 1674)

    Ürümqi, Xinjiang, 830000

  • Wuhan Union Hospital Cancer Center-Cancer Center ( Site 1664)

    Wuhan, Hubei, 430022

  • The Third Hospital of Zhengzhou-Oncology ( Site 1653)

    Zhengzhou, Henan, 450001

Other trials in China

Germany13 sites

  • Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 0756)

    Berlin, 10117

  • Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0754)

    Buxtehude, Lower Saxony, 21614

  • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0766)

    Dresden, Saxony, 01307

  • Universitaetsklinikum Erlangen-Hautklinik ( Site 0750)

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0761)

    Essen, North Rhine-Westphalia, 45147

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 0752)

    Hamburg, 20246

  • Medizinische Hochschule Hannover ( Site 0758)

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum Heidelberg ( Site 0765)

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel-Hautklinik ( Site 0767)

    Kiel, Schleswig-Holstein, 24105

  • Universitätsklinikum Leipzig ( Site 0762)

    Leipzig, Saxony, 04103

  • Universitätsmedizin Mannheim ( Site 0751)

    Mannheim, Baden-Wurttemberg, 68167

  • Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 0759)

    Minden, North Rhine-Westphalia, 32429

  • Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 0757)

    München, Bavaria, 80337

Other trials in Germany

Australia11 sites

  • Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457)

    Adelaide, South Australia, 5000

  • Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464)

    Blacktown, New South Wales, 2148

  • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si

    Brisbane, Queensland, 4029

  • Cairns Hospital-Clinical Research Unit ( Site 1458)

    Cairns, Queensland, 4870

  • Gallipoli Medical Research Ltd-GMRF CTU ( Site 1451)

    Greenslopes, Queensland, 4120

  • Icon Cancer Centre Hobart ( Site 1465)

    Hobart, Tasmania, 7000

  • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455)

    Melbourne, Victoria, 3000

  • One Clinical Research ( Site 1460)

    Nedlands, Western Australia, 6009

  • Tasman Oncology Research ( Site 1456)

    Southport, Queensland, 4215

  • Calvary Mater Newcastle-Medical Oncology ( Site 1462)

    Waratah, New South Wales, 2298

  • Melanoma Institute Australia-Clinical Trials Unit ( Site 1450)

    Wollstonecraft, New South Wales, 2065

Other trials in Australia

Poland11 sites

  • Bialostockie Centrum Onkologii ( Site 1065)

    Bialystok, Podlaskie Voivodeship, 15-027

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1061)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

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

    Gdansk, Pomeranian Voivodeship, 80-214

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1056)

    Gliwice, Silesian Voivodeship, 44-101

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1054)

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • Pratia MCM Krakow ( Site 1053)

    Krakow, Lesser Poland Voivodeship, 30-727

  • Szpital Kliniczny im. H. Swiecickiego nr 2-Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej (

    Poznan, Greater Poland Voivodeship, 60-780

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1058)

    Siedlce, Masovian Voivodeship, 08-110

  • Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1064)

    Słupsk, Pomeranian Voivodeship, 76-200

  • Zachodniopomorskie Centrum Onkologii ( Site 1063)

    Szczecin, West Pomeranian Voivodeship, 71-730

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

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

South Africa10 sites

  • Cape Town Oncology Trials ( Site 1155)

    Cape Town, Western Cape, 7570

  • The Oncology Centre ( Site 1157)

    Durban, KwaZulu-Natal, 4091

  • Medical Oncology Centre of Rosebank ( Site 1160)

    Johannesburg, Gauteng, 2196

  • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 1161)

    Port Elizabeth, Eastern Cape, 6055

  • Wilgers Oncology Centre ( Site 1154)

    Pretoria, Gauteng, 0040

  • Curo Oncology ( Site 1158)

    Pretoria, Gauteng, 0084

  • LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1152)

    Pretoria, Gauteng, 0181

  • Abraham Oncology ( Site 1150)

    Richards Bay, KwaZulu-Natal, 3900

  • Cancercare Rondebosch Oncology-Clinical trials ( Site 1159)

    Rondebosch, Western Cape, 7700

  • Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 1151)

    Sandton, Gauteng, 2196

Other trials in South Africa

France9 sites

  • Hopital Claude Huriez - CHU de Lille-Clinique de Dermatologie ( Site 0700)

    Lille, Hauts-de-France, 59037

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi

    Marseille, Provence-Alpes-Côte d'Azur Region, 13005

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Onco-Dermatology ( Site 0707)

    Nantes, Loire-Atlantique, 44093

  • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0711)

    Paris, 75014

  • Centre Hospitalier de Pau ( Site 0708)

    Pau, Pyrenees-Atlantiques, 64000

  • centre hospitalier lyon sud-Service de dermatologie ( Site 0714)

    Pierre-Bénite, Rhone, 69310

  • Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 0706)

    Saint-Herblain, Loire-Atlantique, 44805

  • Centre Hospitalier de Valence-Service de Dermatologie ( Site 0702)

    Valence, Drome, 26953

  • Gustave Roussy-Dermatologie ( Site 0713)

    Villejuif, Val-de-Marne, 94800

Other trials in France

Italy9 sites

  • Instituto Tumori Giovanni Paolo II ( Site 1003)

    Bari, Apulia, 70124

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1004)

    Meldola, Emilia-Romagna, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1000)

    Milan, Lombardy, 20133

  • Istituto Europeo di Oncologia IRCCS ( Site 1008)

    Milan, 20141

  • Azienda Ospedaliero Universitaria ( Site 1002)

    Modena, 41125

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1001)

    Naples, 80131

  • A.O.U. Policlinico Paolo Giaccone-Depatment of Discipline Chirurgiche, Oncologiche e Stomatologiche

    Palermo, Sicily, 90129

  • AO Santa Maria della Misericordia ( Site 1006)

    Perugia, Umbria, 06129

  • Azienda Ospedaliero Universitaria Senese ( Site 1005)

    Siena, Tuscany, 53100

Other trials in Italy

Switzerland8 sites

  • University Hospital Basel ( Site 1303)

    Basel, Canton of Basel-City, 4056

  • Ospedale Regionale Bellinzona e Valli ( Site 1308)

    Bellinzona, Canton Ticino, 6500

  • Inselspital Bern ( Site 1301)

    Bern, Canton of Bern, 3010

  • Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1307)

    Geneva, Canton of Geneva, 1211

  • CHUV (centre hospitalier universitaire vaudois) ( Site 1304)

    Lausanne, Canton of Vaud, 1011

  • Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 1306)

    Sankt Gallen, 9007

  • Hôpital de Sion ( Site 1305)

    Sion, Valais, 1951

  • UniversitätsSpital Zürich-Dermatology ( Site 1300)

    Zürich Flughafen, Canton of Zurich, 8058

Other trials in Switzerland

Turkey (Türkiye)8 sites

  • Hacettepe Universite Hastaneleri ( Site 1363)

    Ankara, 06230

  • Liv Hospital Ankara-Oncology ( Site 1353)

    Ankara, 06680

  • Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1355)

    Antalya, 07059

  • Ankara City Hospital-Medical Oncology ( Site 1357)

    Çankaya, Ankara, 06800

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1358)

    Istanbul, 34722

  • I.E.U. Medical Point Hastanesi-Oncology ( Site 1360)

    Izmir, Karsiyaka, İzmir, 009035575

  • Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1361)

    Mersin, 33240

  • Ondokuz Mayıs Universitesi-Oncology department ( Site 1359)

    Samsun, 55139

Other trials in Turkey (Türkiye)

Chile7 sites

  • Bradford Hill Norte ( Site 0308)

    Antofagasta, 1240000

  • FALP-UIDO ( Site 0303)

    Santiago, Region M. de Santiago, 7500921

  • Oncovida ( Site 0304)

    Santiago, Region M. de Santiago, 7510032

  • Clínica UC San Carlos de Apoquindo ( Site 0305)

    Santiago, Region M. de Santiago, 7620002

  • Bradfordhill-Clinical Area ( Site 0302)

    Santiago, Region M. de Santiago, 8420383

  • Oncocentro Valdivia ( Site 0307)

    Valdivia, Los Ríos Region, 5112129

  • ONCOCENTRO APYS-ACEREY ( Site 0300)

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Argentina6 sites

  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0200)

    Buenos Aires, Buenos Aires F.D., C1431FWO

  • Sanatorio Finochietto ( Site 0212)

    Buenos Aires, C1187AAN

  • Clinica Adventista Belgrano-Oncology ( Site 0211)

    CABA, C1430EGF

  • Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0204)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1027AAP

  • Instituto Alexander Fleming-Alexander Fleming ( Site 0209)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

  • Instituto de Oncología de Rosario ( Site 0206)

    Rosario, Santa Fe Province, S2000KZE

Other trials in Argentina

Austria6 sites

  • Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0601)

    Graz, Styria, 8036

  • Medizinische Universitaet Innsbruck-Univ Klinik für Dermatologie, Venerologie und Allergologie ( Sit

    Innsbruck, Tyrol, 6020

  • Ordensklinikum Linz GmbH Elisabethinen-Dermatologie ( Site 0602)

    Linz, Upper Austria, 4020

  • Uniklinikum Salzburg-Department of Dermatology and Allergology ( Site 0604)

    Salzburg, 5020

  • Universitätsklinikum St. Pölten-Department of Dermatology ( Site 0606)

    Sankt Pölten, Lower Austria, 3100

  • Medizinische Universität Wien-Department of Dermatology ( Site 0600)

    Vienna, State of Vienna, 1090

Other trials in Austria

Belgium6 sites

  • Cliniques universitaires Saint-Luc ( Site 0652)

    Brussels, Bruxelles-Capitale, Region de, 1200

  • Jessa Ziekenhuis ( Site 0656)

    Hasselt, Limburg, 3500

  • UZ Leuven-General Medical Oncology ( Site 0650)

    Leuven, Vlaams-Brabant, 3000

  • VITAZ-Medical Oncology ( Site 0654)

    Sint-Niklaas, Oost-Vlaanderen, B-9100

  • GZA Ziekenhuizen campus Sint-Augustinus ( Site 0655)

    Wilrijk, Antwerpen, 2610

  • Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0653)

    Yvoir, Namur, 5530

Other trials in Belgium

Brazil6 sites

  • Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 0256)

    Belo Horizonte, Minas Gerais, 30130090

  • ANIMI - Unidade de Tratamento Oncologico ( Site 0255)

    Lages, Santa Catarina, 88501001

  • Hospital de Cancer de Londrina-Clinical Research Unit ( Site 0252)

    Londrina, Paraná, 86015-520

  • Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 0259)

    Passo Fundo, Rio Grande do Sul, 99010-080

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia ( Site 0262)

    Santo André, São Paulo, 09060-870

  • A. C. Camargo Cancer Center ( Site 0258)

    São Paulo, 01509-010

Other trials in Brazil

Israel6 sites

  • Emek Medical Center-oncology ( Site 0952)

    Afula, 1834111

  • Soroka Medical Center ( Site 0953)

    Beersheba, 8410101

  • Rambam Health Care Campus-Oncology Division ( Site 0955)

    Haifa, 3109601

  • Hadassah Medical Center ( Site 0951)

    Jerusalem, 9112001

  • Rabin Medical Center-Oncology ( Site 0954)

    Petah Tikva, 4941492

  • Sheba Medical Center-ONCOLOGY ( Site 0950)

    Ramat Gan, 5265601

Other trials in Israel

Japan6 sites

  • National Cancer Center Hospital ( Site 1750)

    Chuo-ku, Tokyo, 104-0045

  • Shizuoka Cancer Center ( Site 1752)

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

  • Nagoya University Hospital ( Site 1753)

    Nagoya, Aichi-ken, 466-8560

  • Niigata Cancer Center Hospital ( Site 1751)

    Niigata, Niigata, 951-8566

  • Osaka International Cancer Institute ( Site 1754)

    Osaka, 541-8567

  • Sapporo Medical University Hospital ( Site 1755)

    Sapporo, Hokkaido, 060-8543

Other trials in Japan

Spain6 sites

  • Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1203)

    Doniostia - San Sebastian, Gipuzkoa, 20014

  • Institut Català d'Oncologia - L'Hospitalet ( Site 1202)

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1204)

    Madrid, Madrid, Comunidad de, 28034

  • H.R.U Málaga - Hospital General-Oncology ( Site 1201)

    Málaga, Malaga, 29011

  • Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1205)

    Seville, 41009

  • Hospital General Universitario de Valencia ( Site 1200)

    Valencia, Valenciana, Comunitat, 46014

Other trials in Spain

Colombia5 sites

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0358)

    Bogotá, Bogota D.C., 111321

  • Fundación Valle del Lili ( Site 0352)

    Cali, Valle del Cauca Department, 760032

  • Mediservis del Tolima IPS S.A.S ( Site 0357)

    Ibague, Tolima Department, 730006

  • Instituto de Cancerología ( Site 0356)

    Medellín, Antioquia, 050025

  • Fundación Colombiana de Cancerología Clínica Vida ( Site 0355)

    Medellín, Antioquia, 050030

Other trials in Colombia

New Zealand5 sites

  • Harbour Cancer & Wellness ( Site 1508)

    Auckland, 0627

  • New Zealand Clinical Research (Christchurch) ( Site 1509)

    Christchurch, Canterbury, 8011

  • Dunedin Hospital ( Site 1511)

    Dunedin, Otago, 9016

  • P3 Research - Palmerston North ( Site 1510)

    Palmerston North, Manawatu-Wanganui, 4414

  • Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1501)

    Tauranga, Bay of Plenty, 3112

Other trials in New Zealand

Canada3 sites

  • The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0004)

    Ottawa, Ontario, K1H 8L6

  • Sunnybrook Research Institute ( Site 0003)

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre ( Site 0006)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

India3 sites

  • Artemis hospital ( Site 1551)

    Gurugram, Haryana, 122001

  • Tata Memorial Hospital-Medical Oncology ( Site 1550)

    Mumbai, Maharashtra, 400012

  • All India Institute of Medical Sciences-Medical oncology ( Site 1552)

    New Delhi, National Capital Territory of Delhi, 110029

Other trials in India

South Korea3 sites

  • Seoul National University Hospital-Oncology ( Site 1600)

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1601)

    Seoul, 03722

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 1602)

    Seoul, 06351

Other trials in South Korea

United Kingdom3 sites

  • Addenbrooke's Hospital ( Site 1400)

    Cambridge, Cambridgeshire, CB2 2QQ

  • University College London Hospital ( Site 1405)

    London, England, NW1 2PG

  • Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1401)

    London, London, City of, SE1 9RT

Other trials in United Kingdom

Ireland2 sites

  • St. James's Hospital-Cancer clinical trials office ( Site 0900)

    Dublin, D08 E9P6

  • Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 0902)

    Dublin, Dublin 9

Other trials in Ireland

Sweden2 sites

  • Länssjukhuset Ryhov-Onkologkliniken ( Site 1253)

    Jönköping, Jönköping County, 553 05

  • Karolinska Universitetssjukhuset Solna ( Site 1252)

    Stockholm, Stockholm County, 171 64

Other trials in Sweden

About this study

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)

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.

Read the 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 were analyzed in the End of Trial analysis with a data cut-off of 24-Sep-2025 (Study Completion Date).

Conditions
Melanoma
Being tested
Pembrolizumab/Vibostolimab, Pembrolizumab
Keywords
Programmed Cell Death-1 (PD1, PD-1), T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT)
Medical subject headings
Melanoma, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

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

  • Pembrolizumab/VibostolimabBiological

    Also called MK-7684A

    Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 17 administrations

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    Pembrolizumab 25 mg/mL administered as IV infusion for up to 17 administrations

Study groups in NCT05665595
Study groupRoleWhat they receive
Pembrolizumab/VibostolimabExperimentalParticipants 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).
Receives: Biological: Pembrolizumab/Vibostolimab
PembrolizumabActive comparatorParticipants 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).
Receives: Biological: Pembrolizumab

What is being measured

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

  1. Recurrence-Free Survival (RFS)

    RFS is defined as the 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.

    Measured: Up to approximately 13 months

Secondary outcomes (2)

  1. Number of Participants Who Experienced At Least One or More Adverse Events (AE)

    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.

    Measured: Up to approximately 20 months

  2. Number of Participants Who Discontinued Study Treatment Due to an AE

    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.

    Measured: Up to approximately 18 months

Timeline

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

  1. First posted27 Dec 2022
  2. Study start19 Jan 2023
  3. Primary completion6 Mar 2024
  4. Study completion24 Sep 2025

Why it stopped: Business Reason

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,594 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05665595
Sponsor's protocol ID
7684A-010
Other IDs
MK-7684A-010, KEYVIBE-010, 2022-501417-31-00, jRCT2031230099, U1111-1280-3661
Status last verified
Aug 2026
First submitted
16 Dec 2022
Last updated
10 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Dummer R, Guo J, Luke JJ, Carlino MS, Schadendorf D, Khattak MA, Hauschild A, Ascierto PA, Chen Y, Shin SJ, Rutkowski P, Luo Z, Chen J, Rivalland G, Coetzee C, Ribas A, Mujika K, Markel G, Villarroel RU, Dizdar O, Caglevic C, Grebennik D, Donovan K, Krepler C, Long GV. Vibostolimab coformulated with pembrolizumab versus pembrolizumab alone as adjuvant therapy for high-risk stage IIB-IV melanoma (KEYVIBE-010): a randomised, double-blind, phase 3 study. Lancet Oncol. 2026 Mar;27(3):327-339. doi: 10.1016/S1470-2045(25)00709-0. Epub 2026 Feb 13.

    PubMed 41698381

  • Shapira-Frommer R, Niu J, Perets R, Peters S, Shouse G, Lugowska I, Garassino MC, Sands J, Keenan T, Zhao B, Healy J, Ahn MJ. The KEYVIBE program: vibostolimab and pembrolizumab for the treatment of advanced malignancies. Future Oncol. 2024;20(27):1983-1991. doi: 10.1080/14796694.2024.2343272. Epub 2024 Sep 4.

    PubMed 39230120

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab/Vibostolimab and Pembrolizumab in people with Melanoma, run by Merck Sharp & Dohme LLC at 205 sites in 26 countries.

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

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 205 sites in United States, China, Germany, Australia, Poland and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Recurrence-Free Survival (RFS) (time frame: Up to approximately 13 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05665595, which also lists 2 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in