A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010)
研究单位：[1]Merck Sharp & Dohme LLC[2]Eisai Inc.[3]Eisai Inc.[4]California Cancer Associates for Research & Excellence ( Site 0025),Fresno,California,United States,93720[5]California Cancer Associates for Research & Excellence ( Site 0059),San Marcos,California,United States,92069[6]University of Colorado Cancer Center ( Site 0023),Aurora,Colorado,United States,80045[7]University of Connecticut Health Center ( Site 0020),Farmington,Connecticut,United States,06030[8]Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069),Hollywood,Florida,United States,33021[9]Georgia Cancer Center at Augusta University ( Site 0013),Augusta,Georgia,United States,30912[10]Northwest Georgia Oncology Centers PC ( Site 0028),Marietta,Georgia,United States,30060[11]University of Kansas Cancer Center ( Site 0033),Westwood,Kansas,United States,66205[12]University of Louisville, James Graham Brown Cancer Center ( Site 0045),Louisville,Kentucky,United States,40202[13]Dana Farber Cancer Institute ( Site 0019),Boston,Massachusetts,United States,02215[14]University of Michigan ( Site 0064),Ann Arbor,Michigan,United States,48109-5936[15]Karmanos Cancer Institute ( Site 0054),Detroit,Michigan,United States,48201[16]Henry Ford Health System ( Site 0001),Detroit,Michigan,United States,48202[17]Washington University School of Medicine ( Site 0060),Saint Louis,Missouri,United States,63110[18]St. Vincent Frontier Cancer Center ( Site 0008),Billings,Montana,United States,59102[19]Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0053),Omaha,Nebraska,United States,68130[20]John Theurer Cancer Center at Hackensack University Medical Center ( Site 0002),Hackensack,New Jersey,United States,07601[21]Weill Cornell Medicine New York Presbyterian Hospital ( Site 0040),New York,New York,United States,10021[22]SUNY Upstate Medical University ( Site 0051),Syracuse,New York,United States,13210[23]University of North Carolina- Chapel Hill ( Site 0056),Chapel Hill,North Carolina,United States,27514[24]Duke Cancer Center ( Site 0044),Durham,North Carolina,United States,27710[25]Providence Portland Medical Center ( Site 0048),Portland,Oregon,United States,97213[26]Blue Ridge Cancer Care ( Site 0015),Blacksburg,Virginia,United States,24060[27]Inova Schar Cancer Institute ( Site 0009),Fairfax,Virginia,United States,22031[28]Cancer Care Northwest ( Site 0017),Spokane Valley,Washington,United States,99216[29]University of Wisconsin- Madison Carbone Cancer Center ( Site 0006),Madison,Wisconsin,United States,53792[30]Chris OBrien Lifehouse ( Site 1002),Camperdown,New South Wales,Australia,2050[31]St George Hospital ( Site 1001),Kogarah,New South Wales,Australia,2217[32]Royal Adelaide Hospital ( Site 1004),Adelaide,South Australia,Australia,5000[33]Oncocentro Ceara ( Site 0412),Fortaleza,Ceara,Brazil,60135-237[34]Fundacao Sao Francisco Xavier ( Site 0409),Ipatinga,Minas Gerais,Brazil,35162-189[35]ELO Pesquisa Clinica ( Site 0405),Maringa,Parana,Brazil,87015-200[36]Hospital de Passo Fundo ( Site 0401),Passo Fundo,Rio Grande Do Sul,Brazil,99010-260[37]Clinica LACKS ( Site 0402),Pelotas,Rio Grande Do Sul,Brazil,96020-080[38]Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0414),Porto Alegre,Rio Grande Do Sul,Brazil,91350-200[39]A.C. Camargo Cancer Center ( Site 0407),Sao Paulo,Brazil,01509-900[40]Princess Margaret Cancer Centre ( Site 0200),Toronto,Ontario,Canada,M5G 1Z5[41]McGill University Health Centre ( Site 0206),Montreal,Quebec,Canada,H4A 3J1[42]Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0,Quebec City,Quebec,Canada,G1J 1Z4[43]Beijing Cancer Hospital ( Site 3314),Beining,Beijing,China,100036[44]Peking Union Medical College Hospital ( Site 3304),Bejiing,Beijing,China,100032[45]Chongqing Cancer Hospital ( Site 3327),Chongqing,Chongqing,China,400030[46]Fujian Provincial Cancer Hospital ( Site 3326),Fuzhou,Fujian,China,350014[47]Guangxi Medical University Affiliated Tumor Hospital ( Site 3322),Nanning,Guangxi,China,530000[48]Guizhou Cancer Hospital ( Site 3330),Guiyang,Guizhou,China,550003[49]The Third Affiliated Hospital of Harbin Medical University ( Site 3302),Harbin,Heilongjiang,China,150081[50]Henan Cancer Hospital ( Site 3309),Zhengzhou,Henan,China,450008[51]Wuhan Union hospital Cancer Center ( Site 3307),Wuhan,Hubei,China,430000[52]Tongji Hospital Tongji Medical,Science & Technology ( Site 3316),Wuhan,Hubei,China,430030[53]Hunan Cancer Hospital ( Site 3311),Changsha,Hunan,China,410000[54]Xiangya Hospital of Central South University ( Site 3305),Changsha,Hunan,China,410008[55]Jiangxi Cancer Hospital ( Site 3313),Nanchang,Jiangxi,China,330029[56]Jilin Cancer Hospital ( Site 3310),Changchun,Jilin,China,130000[57]The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328),XI An,Shaanxi,China,710000[58]Fudan University Shanghai Cancer Center ( Site 3324),Shanghai,Shanghai,China,200032[59]Shanghai East Hospital ( Site 3300),Shanghai,Shanghai,China,200120[60]West China Hospital of Sichuan University ( Site 3308),Chengdu,Sichuan,China,610047[61]Tianjin Medical University Cancer Hospital ( Site 3312),Tianjin,Tianjin,China,300060[62]Zhejiang Cancer Hospital ( Site 3303),Hangzhou,Zhejiang,China,310022[63]Centre Leon Berard ( Site 1901),Lyon,Auvergne,France,69008[64]Hopital de la Timone ( Site 1903),Marseille,Bouches-du-Rhone,France,13005[65]Hopital Foch ( Site 1905),Suresnes,Hauts-de-Seine,France,92151[66]Centre Henri Becquerel ( Site 1904),Rouen,Seine-Maritime,France,76038[67]Gustave Roussy ( Site 1906),Villejuif,Val-de-Marne,France,94800[68]Universitaetsklinikum Tuebingen ( Site 2108),Tuebingen,Baden-Wurttemberg,Germany,72076[69]Universitaetsklinikum Ulm ( Site 2102),Ulm,Baden-Wurttemberg,Germany,89075[70]Universitaetsklinikum Regensburg ( Site 2100),Regensburg,Bayern,Germany,93053[71]Universitaetsklinikum Frankfurt ( Site 2107),Frankfurt,Hessen,Germany,60590[72]KRH Klinikum Siloah ( Site 2103),Hannover,Niedersachsen,Germany,30459[73]Universitaetsklinikum Koeln ( Site 2111),Koeln,Nordrhein-Westfalen,Germany,50937[74]Universitätsklinikum Leipzig-Department for ENT ( Site 2106),Leipzig,Sachsen,Germany,04103[75]Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 2112),Berlin,Germany,12203[76]Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce,Miskolc,Borsod-Abauj-Zemplen,Hungary,3526[77]Szegedi Egyetem Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2207),Szeged,Csongrad,Hungary,6720[78]Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 2200),Szolnok,Jasz-Nagykun-Szolnok,Hungary,5004[79]Uzsoki Utcai Korhaz ( Site 2201),Budapest,Vas,Hungary,1145[80]Orszagos Onkologiai Intezet ( Site 2202),Budapest,Hungary,1122[81]Debreceni Egyetem Klinikai Kozpont ( Site 2206),Debrecen,Hungary,4032[82]Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 2402),Brescia,Italy,25123[83]Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2400),Milano,Italy,20133[84]IEO Istituto Europeo di Oncologia ( Site 2406),Milano,Italy,20141[85]ASST Santi Paolo e Carlo - Presidio Ospedaliero San Paolo ( Site 2405),Milano,Italy,20142[86]Istituto Oncologico Veneto ( Site 2404),Padova,Italy,35128[87]ASL Liguria 2 - Ospedale San Paolo ( Site 2401),Savona,Italy,17100[88]Aichi Cancer Center Hospital ( Site 1113),Nagoya,Aichi,Japan,4648681[89]Nagoya University Hospital ( Site 1106),Nagoya,Aichi,Japan,466-8560[90]Chiba cancer center ( Site 1110),Chiba-shi,Chiba,Japan,260-8717[91]National Cancer Center Hospital East ( Site 1100),Kashiwa,Chiba,Japan,2778577[92]Hyogo Cancer Center ( Site 1112),Akashi,Hyogo,Japan,673-8558[93]Kagawa University Hospital ( Site 1108),Kita-gun,Kagawa,Japan,761-0793[94]Yokohama City University Hospital ( Site 1104),Yokohama,Kanagawa,Japan,2360064[95]Kindai University Hospital ( Site 1107),Osakasayama,Osaka,Japan,5898511[96]Shizuoka Cancer Center Hospital and Research Institute ( Site 1105),Sunto-gun,Shizuoka,Japan,411-8777[97]National Hospital Organization Kyushu Medical Center ( Site 1111),Fukuoka,Japan,810-8563[98]Hiroshima University Hospital ( Site 1109),Hiroshima,Japan,7348551[99]National Cancer Center Hospital ( Site 1102),Tokyo,Japan,104-0045[100]The Cancer Institute Hospital of JFCR ( Site 1103),Tokyo,Japan,135-8550[101]Tokyo Medical and Dental University Hospital ( Site 1101),Tokyo,Japan[102]Chonnam National University Hwasun Hospital ( Site 1202),Hwasun-gun,Jeonranamdo,Korea, Republic of,58128[103]Seoul National University Bundang Hospital ( Site 1205),Seongnam-si,Kyonggi-do,Korea, Republic of,13620[104]Ajou University Hospital ( Site 1200),Suwon-si,Kyonggi-do,Korea, Republic of,16499[105]Asan Medical Center ( Site 1201),Songpa-gu,Seoul,Korea, Republic of,05505[106]Keimyung University Dongsan Hospital ( Site 1203),Daegu,Taegu-Kwangyokshi,Korea, Republic of,42601[107]The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1204),Seoul,Korea, Republic of,03312[108]Cryptex Investigación Clínica S.A. de C.V. ( Site 0608),Cuauhtémoc, Mexico City,Distrito Federal,Mexico,06100[109]Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0602),Monterrey,Nuevo Leon,Mexico,64460[110]Christus Muguerza Clinica Vidriera ( Site 0607),Monterrey,Nuevo Leon,Mexico,64570[111]Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0604),Cancun,Quintana Roo,Mexico,77500[112]Oaxaca Site Management Organization S.C. ( Site 0603),Oaxaca,Mexico,68000[113]Instituto Nacional de Enfermedades Neoplasicas ( Site 0701),Lima,Muni Metro De Lima,Peru,Lima 34[114]Hospital Nacional Guillermo Almenara Irigoyen ( Site 0700),Lima,Peru,15033[115]Hospital Nacional Edgardo Rebagliati Martins ( Site 0702),Lima,Peru,15072[116]Hospital Nacional Arzobispo Loayza ( Site 0703),Lima,Peru,15082[117]Hospital Nacional Cayetano Heredia ( Site 0704),Lima,Peru,15102[118]Dolnoslaskie Centrum Onkologii. ( Site 2507),Wroclaw,Dolnoslaskie,Poland,53-413[119]Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 2508),Bydgoszcz,Kujawsko-pomorskie,Poland,85-796[120]Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2502),Krakow,Malopolskie,Poland,31-826[121]Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Glowy i Szyi ( Site,Warszawa,Mazowieckie,Poland,02-781[122]Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2504),Gdynia,Pomorskie,Poland,81-519[123]Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2506),Gliwice,Slaskie,Poland,44-101[124]Przychodnia Lekarska Komed ( Site 2500),Konin,Wielkopolskie,Poland,62-500[125]Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 2509),Poznan,Wielkopolskie,Poland,60-780[126]Altay Regional Oncology Dispensary ( Site 2611),Barnaul,Altayskiy Kray,Russian Federation,656045[127]FSCC FMBA of Russia ( Site 2603),Moscow,Moskva,Russian Federation,115682[128]Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2609),Kazan,Tatarstan, Respublika,Russian Federation,420029[129]Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2605),Yaroslavl,Yaroslavskaya Oblast,Russian Federation,150054[130]Hospital Duran i Reynals ( Site 2701),Hospitalet de Llobregat,Barcelona,Spain,08908[131]H.U. Vall de Hebron ( Site 2700),Barcelona,Spain,08035[132]Hospital Universitario 12 de Octubre ( Site 2702),Madrid,Spain,28041[133]Hospital Universitario La Paz ( Site 2706),Madrid,Spain,28046[134]Hospital de Valme ( Site 2705),Sevilla,Spain,41014[135]Hospital Clinico Universitario Lozano Blesa ( Site 2703),Zaragoza,Spain,50009[136]National Cheng Kung University Hospital ( Site 1603),Taiwan,Tainan,Taiwan,704[137]Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1604),Kaohsiung,Taiwan,833[138]National Taiwan University Hospital ( Site 1600),Taipei,Taiwan,10048[139]MacKay Memorial Hospital ( Site 1602),Taipei,Taiwan,10449[140]Taipei Veterans General Hospital ( Site 1601),Taipei,Taiwan,11217[141]Hacettepe Universitesi Tip Fakultesi ( Site 2805),Ankara,Turkey,06230[142]Ankara Sehir Hastanesi ( Site 2802),Ankara,Turkey,06800[143]Trakya Universitesi Tip Fakultesi ( Site 2801),Edirne,Turkey,22030[144]Medipol Universite Hastanesi ( Site 2800),Istanbul,Turkey,34214[145]Ege Universitesi Tip Fakultesi Hastanesi ( Site 2804),Izmir,Turkey,35040[146]Medical Park Izmir Hospital ( Site 2807),Izmir,Turkey,35575[147]Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 2803),Malatya,Turkey,44280[148]Aberdeen Royal Infirmary ( Site 2905),Aberdeen,Aberdeen City,United Kingdom,AB25 2ZN[149]Guy's Hospital in London ( Site 2908),London,London, City Of,United Kingdom,SE1 9RT[150]Royal Marsden NHS Foundation Trust ( Site 2910),London,London, City Of,United Kingdom,SW3 6JJ[151]Mount Vernon Cancer Centre ( Site 2902),Northwood,London, City Of,United Kingdom,HA6 2RN[152]Royal Marsden Hospital ( Site 2904),Sutton,London, City Of,United Kingdom,SM2 5PT[153]Nottingham City Hospital ( Site 2907),Nottingham,Nottinghamshire,United Kingdom,NG5 1PB[154]Taunton and Somerset Hospital ( Site 2900),Taunton,Somerset,United Kingdom,TA1 5DA[155]Christie NHS Foundation Trust ( Site 2903),Manchester,United Kingdom,M20 4BX
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: - Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). - Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. - Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).
