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)
Melanoma
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Programmed Cell Death-1 (PD1, PD-1), T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT)
Eligibility Criteria
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
Sites / Locations
- The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123)Recruiting
- California Pacific Medical Center - Pacific Campus ( Site 0111)Recruiting
- UCSF Medical Center at Mission Bay ( Site 0130)Recruiting
- Georgetown University Medical Center ( Site 0144)Recruiting
- University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110)Recruiting
- Northwestern Memorial Hospital ( Site 0109)Recruiting
- Advocate Medical Group-Oncology ( Site 0102)Recruiting
- Comprehensive Cancer Centers of Nevada ( Site 0142)Recruiting
- Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113)Recruiting
- Sanford Fargo Medical Center ( Site 0127)Recruiting
- Children's Hospital of Pittsburgh ( Site 0141)Recruiting
- UPMC Hillman Cancer Center ( Site 0135)Recruiting
- Sanford Cancer Center ( Site 0125)Recruiting
- The West Clinic, PLLC dba West Cancer Center ( Site 0119)Recruiting
- Inova Schar Cancer Institute ( Site 0103)Recruiting
- University of Wisconsin Hospital and Clinics ( Site 0108)Recruiting
- Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0204)Recruiting
- Instituto Alexander Fleming-Alexander Fleming ( Site 0209)Recruiting
- Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0200)Recruiting
- Instituto de Oncología de Rosario ( Site 0206)Recruiting
- Sanatorio Finochietto ( Site 0212)Recruiting
- Clinica Adventista Belgrano-Oncology ( Site 0211)Recruiting
- Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464)Recruiting
- Calvary Mater Newcastle-Medical Oncology ( Site 1462)Recruiting
- Melanoma Institute Australia-Clinical Trials Unit ( Site 1450)Recruiting
- Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( SiRecruiting
- Gallipoli Medical Research Foundation-GMRF CTU ( Site 1451)Recruiting
- Cairns Hospital-Clinical Research Unit ( Site 1458)Recruiting
- Tasman Oncology Research ( Site 1456)Recruiting
- Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457)Recruiting
- Icon Cancer Centre Hobart ( Site 1465)Recruiting
- Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455)Recruiting
- One Clinical Research ( Site 1460)Recruiting
- Ordensklinikum Linz GmbH Elisabethinen-Dermatologie ( Site 0602)Recruiting
- Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0601)Recruiting
- Medizinische Universitaet Innsbruck-Univ Klinik für Dermatologie, Venerologie und Allergologie ( SitRecruiting
- Medizinische Universität Wien-Department of Dermatology ( Site 0600)Recruiting
- Uniklinikum Salzburg-Department of Dermatology and Allergology ( Site 0604)Recruiting
- Jessa Ziekenhuis ( Site 0656)Recruiting
- VITAZ-Medical Oncology ( Site 0654)Recruiting
- UZ Leuven-General Medical Oncology ( Site 0650)Recruiting
- Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 0256)Recruiting
- Hospital de Cancer de Londrina-Clinical Research Unit ( Site 0252)Recruiting
- Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 0259)Recruiting
- ANIMI - Unidade de Tratamento Oncologico ( Site 0255)Recruiting
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia ( Site 0262)Recruiting
- A. C. Camargo Cancer Center ( Site 0258)Recruiting
- The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0004)Recruiting
- Princess Margaret Cancer Centre ( Site 0006)Recruiting
- Oncocentro Valdivia ( Site 0307)Recruiting
- FALP-UIDO ( Site 0303)Recruiting
- Oncovida ( Site 0304)Recruiting
- Clínica UC San Carlos de Apoquindo ( Site 0305)Recruiting
- Bradfordhill-Clinical Area ( Site 0302)Recruiting
- ONCOCENTRO APYS-ACEREY ( Site 0300)Recruiting
- Centro de Investigación Oncológica del Norte ( Site 0308)Recruiting
- Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 1650)Recruiting
- Chongqing University Cancer Hospital ( Site 1651)Recruiting
- Fujian Provincial Cancer Hospital ( Site 1659)Recruiting
- Sun Yat-sen University Cancer Center-melanoma ( Site 1655)Recruiting
- Guangxi Medical University Affiliated Tumor Hospital ( Site 1668)Recruiting
- The Third Hospital of Zhengzhou-Oncology ( Site 1653)Recruiting
- Wuhan Union Hospital Cancer Center-Cancer Center ( Site 1664)Recruiting
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (Recruiting
- Jiangsu Province Hospital-Oncology Department ( Site 1663)Recruiting
- The First Affiliated Hospital of Nanchang University ( Site 1652)Recruiting
- The First Hospital of Jilin University-Oncology ( Site 1665)Recruiting
- Fudan University Shanghai Cancer Center ( Site 1658)Recruiting
- Shanxi Bethune Hospital ( Site 1660)Recruiting
- West China Hospital, Sichuan University-Head and Neck Oncology ( Site 1667)Recruiting
- Zhejiang Cancer Hospital-Oncology ( Site 1661)Recruiting
- Centre Hospitalier de Valence-Service de Dermatologie ( Site 0702)Recruiting
- Hopital Claude Huriez - CHU de Lille-Clinique de Dermatologie ( Site 0700)Recruiting
- Centre Hospitalier de Pau ( Site 0708)Recruiting
- Gustave Roussy-Dermatologie ( Site 0713)Recruiting
- Universitaetsklinikum Heidelberg ( Site 0765)Recruiting
- Universitätsmedizin Mannheim ( Site 0751)Recruiting
- Universitaetsklinikum Erlangen-Hautklinik ( Site 0750)Recruiting
- Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0754)Recruiting
- Medizinische Hochschule Hannover ( Site 0758)Recruiting
- Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0761)Recruiting
- Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 0759)Recruiting
- Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0766)Recruiting
- Universitätsklinikum Leipzig ( Site 0762)Recruiting
- Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 0756)Recruiting
- Universitaetsklinikum Hamburg-Eppendorf ( Site 0752)Recruiting
- All India Institute of Medical Sciences-Medical oncology ( Site 1552)Recruiting
- Artemis hospital ( Site 1551)Recruiting
- Tata Memorial Hospital-Medical Oncology ( Site 1550)Recruiting
- Emek Medical Center-oncology ( Site 0952)Recruiting
- Soroka Medical Center ( Site 0953)Recruiting
- Rambam Health Care Campus-Oncology Division ( Site 0955)Recruiting
- Hadassah Medical Center ( Site 0951)Recruiting
- Rabin Medical Center-Oncology ( Site 0954)Recruiting
- Sheba Medical Center-ONCOLOGY ( Site 0950)Recruiting
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1004)Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1000)Recruiting
- Instituto Tumori Giovanni Paolo II ( Site 1003)Recruiting
- Azienda Ospedaliero Universitaria Senese ( Site 1005)Recruiting
- Istituto Europeo di Oncologia IRCCS ( Site 1008)Recruiting
- Nagoya University Hospital ( Site 1753)Recruiting
- Niigata Cancer Center Hospital ( Site 1751)Recruiting
- Seoul National University Hospital-Oncology ( Site 1600)Recruiting
- Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1601)Recruiting
- Samsung Medical Center-Division of Hematology/Oncology ( Site 1602)Recruiting
- Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1501)Recruiting
- New Zealand Clinical Research (Christchurch) ( Site 1509)Recruiting
- P3 Research - Palmerston North ( Site 1510)Recruiting
- Harbour Cancer & Wellness ( Site 1508)Recruiting
- Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1061)Recruiting
- Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1058)Recruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (Recruiting
- Bialostockie Centrum Onkologii ( Site 1065)Recruiting
- Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( SiteRecruiting
- Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1064)Recruiting
- Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1056)Recruiting
- Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1054)Recruiting
- Szpital Kliniczny im. H. Swiecickiego nr 2-Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej (Recruiting
- CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 1161)Recruiting
- Medical Oncology Centre of Rosebank ( Site 1160)Recruiting
- Wilgers Oncology Centre ( Site 1154)Recruiting
- Curo Oncology ( Site 1158)Recruiting
- Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 1151)Recruiting
- Cape Town Oncology Trials ( Site 1155)Recruiting
- Cancercare Rondebosch Oncology-Clinical trials ( Site 1159)Recruiting
- Institut Català d'Oncologia - L'Hospitalet ( Site 1202)Recruiting
- Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1203)Recruiting
- Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1204)Recruiting
- H.R.U Málaga - Hospital General-Oncology ( Site 1201)Recruiting
- Hospital General Universitario de Valencia ( Site 1200)Recruiting
- Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1205)Recruiting
- Länssjukhuset Ryhov-Onkologkliniken ( Site 1253)Recruiting
- Karolinska Universitetssjukhuset Solna ( Site 1252)Recruiting
- University Hospital Basel ( Site 1303)Recruiting
- Inselspital Bern ( Site 1301)Recruiting
- Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1307)Recruiting
- Ospedale Regionale Bellinzona e Valli ( Site 1308)Recruiting
- CHUV (centre hospitalier universitaire vaudois) ( Site 1304)Recruiting
- Hôpital de Sion ( Site 1305)Recruiting
- UniversitätsSpital Zürich-Dermatology ( Site 1300)Recruiting
- Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 1306)Recruiting
- Ankara City Hospital-Medical Oncology ( Site 1357)Recruiting
- I.E.U. Medical Point Hastanesi-Oncology ( Site 1360)Recruiting
- Hacettepe Universite Hastaneleri ( Site 1363)Recruiting
- Liv Hospital Ankara-Oncology ( Site 1353)Recruiting
- Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1355)Recruiting
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1358)Recruiting
- Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1361)Recruiting
- Ondokuz Mayıs Universitesi-Oncology department ( Site 1359)Recruiting
- Addenbrooke's Hospital ( Site 1400)Recruiting
- University College London Hospital ( Site 1405)Recruiting
- Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1401)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Pembrolizumab/Vibostolimab
Pembrolizumab
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).
Adult participants receive 200 mg and adolescent participants ≥40 kg receive 2 mg/kg (up to a max of 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).