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)-China Extension Study
研究单位：[1]Merck Sharp & Dohme LLC[2]Eisai Inc.[3]Anhui Cancer Hospital-Radiology Department ( Site 3333),Hefei,Anhui,China,230031[4]Beijing Tongren Hospital affiliated to Capital Medical University ( Site 3343),Beijing,Beijing,China,100730[5]Beijing Cancer Hospital ( Site 3314),Beining,Beijing,China,100036[6]Peking Union Medical College Hospital ( Site 3304),Bejiing,Beijing,China,100032[7]Chongqing Cancer Hospital ( Site 3327),Chongqing,Chongqing,China,400030[8]Fujian Provincial Cancer Hospital ( Site 3326),Fuzhou,Fujian,China,350014[9]The First Affiliated Hospital, Sun Yat-sen University ( Site 3344),Guangzhou,Guangdong,China,510080[10]Guangxi Medical University Affiliated Tumor Hospital ( Site 3322),Nanning,Guangxi,China,530000[11]Guizhou Cancer Hospital ( Site 3330),Guiyang,Guizhou,China,550003[12]The Third Affiliated Hospital of Harbin Medical University ( Site 3302),Harbin,Heilongjiang,China,150081[13]Henan Cancer Hospital ( Site 3309),Zhengzhou,Henan,China,450008[14]Wuhan Union hospital Cancer Center ( Site 3307),Wuhan,Hubei,China,430000[15]Tongji Hospital Tongji Medical,Science & Technology ( Site 3316),Wuhan,Hubei,China,430030[16]Hunan Cancer Hospital ( Site 3311),Changsha,Hunan,China,410000[17]Xiangya Hospital of Central South University ( Site 3305),Changsha,Hunan,China,410008[18]Hunan Cancer Hospital ( Site 3334),Changsha,Hunan,China,410013[19]Changzhou Tumor Hospital - Changzhou Fourth People's Hospital ( Site 3339),Changzhou,Jiangsu,China,213000[20]Jiangxi Cancer Hospital ( Site 3313),Nanchang,Jiangxi,China,330029[21]Jilin Cancer Hospital ( Site 3310),Changchun,Jilin,China,130000[22]The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328),XI An,Shaanxi,China,710000[23]Shanghai 9th People hospital ( Site 3332),Shanghai,Shanghai,China,200011[24]Fudan University Shanghai Cancer Center ( Site 3324),Shanghai,Shanghai,China,200032[25]Shanghai East Hospital ( Site 3300),Shanghai,Shanghai,China,200120[26]West China Hospital of Sichuan University ( Site 3308),Chengdu,Sichuan,China,610047[27]Tianjin Medical University Cancer Hospital ( Site 3312),Tianjin,Tianjin,China,300060[28]Zhejiang Cancer Hospital ( Site 3303),Hangzhou,Zhejiang,China,310022
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).
