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)
研究单位：[1]Merck Sharp & Dohme LLC[2]The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123),Los Angeles,California,United States,90025[3]UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131),Los Angeles,California,United States,90095[4]California Pacific Medical Center - Pacific Campus ( Site 0111),San Francisco,California,United States,94115[5]UCSF Medical Center at Mission Bay ( Site 0130),San Francisco,California,United States,94158[6]The Melanoma & Skin Cancer Institute ( Site 0120),Englewood,Colorado,United States,80113[7]Georgetown University Medical Center ( Site 0144),Washington,District of Columbia,United States,20007[8]University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110),Miami,Florida,United States,33136[9]Northwestern Memorial Hospital ( Site 0109),Chicago,Illinois,United States,60611[10]Advocate Medical Group-Oncology ( Site 0102),Park Ridge,Illinois,United States,60068[11]University of Iowa-Holden Comprehensive Cancer Center ( Site 0107),Iowa City,Iowa,United States,52242[12]Henry Ford Hospital ( Site 0133),Detroit,Michigan,United States,48202[13]Comprehensive Cancer Centers of Nevada ( Site 0142),Las Vegas,Nevada,United States,89169[14]R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0132),Lake Success,New York,United States,11042[15]Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0146),Mineola,New York,United States,11501[16]Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113),New York,New York,United States,10016[17]Levine Cancer Institute ( Site 0138),Charlotte,North Carolina,United States,28204[18]Sanford Fargo Medical Center ( Site 0127),Fargo,North Dakota,United States,58102[19]Children''s Hospital of Pittsburgh ( Site 0141),Pittsburgh,Pennsylvania,United States,15224[20]UPMC Hillman Cancer Center ( Site 0135),Pittsburgh,Pennsylvania,United States,15232[21]Sanford Cancer Center ( Site 0125),Sioux Falls,South Dakota,United States,57104[22]The West Clinic, PLLC dba West Cancer Center ( Site 0119),Germantown,Tennessee,United States,38138[23]Inova Schar Cancer Institute ( Site 0103),Fairfax,Virginia,United States,22031[24]University of Wisconsin Hospital and Clinics ( Site 0108),Madison,Wisconsin,United States,53792[25]Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0204),Ciudad Autónoma de Buenos Aires,Buenos Aires,Argentina,C1027AAP[26]Instituto Alexander Fleming-Alexander Fleming ( Site 0209),Ciudad Autónoma de Buenos Aires,Buenos Aires,Argentina,C1426ANZ[27]Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0200),Buenos Aires,Caba,Argentina,C1431FWO[28]Instituto de Oncología de Rosario ( Site 0206),Rosario,Santa Fe,Argentina,S2000KZE[29]Sanatorio Finochietto ( Site 0212),Buenos Aires,Argentina,C1187AAN[30]Clinica Adventista Belgrano-Oncology ( Site 0211),Caba,Argentina,C1430EGF[31]Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464),Blacktown,New South Wales,Australia,2148[32]Calvary Mater Newcastle-Medical Oncology ( Site 1462),Waratah,New South Wales,Australia,2298[33]Melanoma Institute Australia-Clinical Trials Unit ( Site 1450),Wollstonecraft,New South Wales,Australia,2065[34]Royal Brisbane and Women''s Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si,Brisbane,Queensland,Australia,4029[35]Gallipoli Medical Research Foundation-GMRF CTU ( Site 1451),Brisbane,Queensland,Australia,4120[36]Cairns Hospital-Clinical Research Unit ( Site 1458),Cairns,Queensland,Australia,4870[37]Tasman Oncology Research ( Site 1456),Southport,Queensland,Australia,4215[38]Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457),Adelaide,South Australia,Australia,5000[39]Icon Cancer Centre Hobart ( Site 1465),Hobart,Tasmania,Australia,7000[40]Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455),Melbourne,Victoria,Australia,3000[41]One Clinical Research ( Site 1460),Nedlands,Western Australia,Australia,6009[42]Universitätsklinikum St. Pölten-Department of Dermatology ( Site 0606),St. Polten,Niederosterreich,Austria,3100[43]Ordensklinikum Linz GmbH Elisabethinen-Dermatologie ( Site 0602),Linz,Oberosterreich,Austria,4020[44]Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0601),Graz,Steiermark,Austria,8036[45]Medizinische Universitaet Innsbruck-Univ Klinik für Dermatologie, Venerologie und Allergologie ( Sit,Innsbruck,Tirol,Austria,6020[46]Medizinische Universität Wien-Department of Dermatology ( Site 0600),Vienna,Wien,Austria,1090[47]Uniklinikum Salzburg-Department of Dermatology and Allergology ( Site 0604),Salzburg,Austria,5020[48]GZA Ziekenhuizen campus Sint-Augustinus ( Site 0655),Wilrijk,Antwerpen,Belgium,2610[49]Jessa Ziekenhuis ( Site 0656),Hasselt,Limburg,Belgium,3500[50]Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0653),Yvoir,Namur,Belgium,5530[51]VITAZ-Medical Oncology ( Site 0654),Sint-Niklaas,Oost-Vlaanderen,Belgium,B-9100[52]UZ Leuven-General Medical Oncology ( Site 0650),Leuven,Vlaams-Brabant,Belgium,3000[53]Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 0256),Belo Horizonte,Minas Gerais,Brazil,30130090[54]Hospital de Cancer de Londrina-Clinical Research Unit ( Site 0252),Londrina,Parana,Brazil,86015-520[55]Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 0259),Passo Fundo,Rio Grande Do Sul,Brazil,99010-080[56]ANIMI - Unidade de Tratamento Oncologico ( Site 0255),Lages,Santa Catarina,Brazil,88501001[57]CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia ( Site 0262),Santo André,Sao Paulo,Brazil,09060-870[58]A. C. Camargo Cancer Center ( Site 0258),Sao Paulo,Brazil,01509-010[59]The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0004),Ottawa,Ontario,Canada,K1H 8L6[60]Sunnybrook Research Institute ( Site 0003),Toronto,Ontario,Canada,M4N 3M5[61]Princess Margaret Cancer Centre ( Site 0006),Toronto,Ontario,Canada,M5G 2M9[62]Oncocentro Valdivia ( Site 0307),Valdivia,Los Rios,Chile,5112129[63]FALP-UIDO ( Site 0303),Santiago,Region M. De Santiago,Chile,7500921[64]Oncovida ( Site 0304),Santiago,Region M. De Santiago,Chile,7510032[65]Clínica UC San Carlos de Apoquindo ( Site 0305),Santiago,Region M. De Santiago,Chile,7620002[66]Bradfordhill-Clinical Area ( Site 0302),Santiago,Region M. De Santiago,Chile,8420383[67]ONCOCENTRO APYS-ACEREY ( Site 0300),Viña del Mar,Valparaiso,Chile,2520598[68]Bradford Hill Norte ( Site 0308),Antofagasta,Chile,1240000[69]Beijing Ji Shui Tan Hospital ( Site 1657),Beijing,Beijing,China,100035[70]Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 1650),Beijing,Beijing,China,100142[71]Chongqing University Cancer Hospital ( Site 1651),Chongqing,Chongqing,China,400030[72]Fujian Provincial Cancer Hospital ( Site 1659),Fuzhou,Fujian,China,350014[73]Sun Yat-sen University Cancer Center-melanoma ( Site 1655),Guangzhou,Guangdong,China,510060[74]Guangxi Medical University Affiliated Tumor Hospital ( Site 1668),Nanning,Guangxi,China,530021[75]Fourth Hospital of Hebei Medical University ( Site 1669),Shijiazhuang,Hebei,China,050035[76]The Third Hospital of Zhengzhou-Oncology ( Site 1653),Zhengzhou Shi,Henan,China,450001[77]Wuhan Union Hospital Cancer Center-Cancer Center ( Site 1664),Wuhan,Hubei,China,430022[78]The Second Xiangya Hospital of Central South University-Oncology ( Site 1673),Changsha,Hunan,China,410011[79]Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (,NanJing,Jiangsu,China,210000[80]Jiangsu Province Hospital-Oncology Department ( Site 1663),Nanjing,Jiangsu,China,210029[81]The First Affiliated Hospital of Nanchang University ( Site 1652),Nanchang,Jiangxi,China,330006[82]The First Hospital of Jilin University-Oncology ( Site 1665),Changchun,Jilin,China,130021[83]Fudan University Shanghai Cancer Center ( Site 1658),Shanghai,Shanghai,China,200032[84]Shanxi Bethune Hospital ( Site 1660),Taiyuan,Shanxi,China,030032[85]West China Hospital, Sichuan University-Head and Neck Oncology ( Site 1667),Cheng Du,Sichuan,China,610041[86]Tianjin Medical University Cancer Institute & Hospital-Biotherapy ( Site 1671),Tianjin,Tianjin,China[87]Xinjiang Medical University Cancer Hospital - Urumqi-Bone and Soft Tissue Department ( Site 1674),Urumqi,Xinjiang,China,830000[88]Zhejiang Cancer Hospital-Oncology ( Site 1661),Hangzhou,Zhejiang,China,310022[89]Fundación Colombiana de Cancerología Clínica Vida ( Site 0355),Medellin,Antioquia,Colombia,050030[90]Mediservis del Tolima IPS S.A.S ( Site 0357),Ibague,Tolima,Colombia,730006
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.
