Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015) (LEAP-015)
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研究单位：[1]Merck Sharp & Dohme LLC[2]Georgetown University Medical Center ( Site 0009) Washington, District of Columbia, United States, 20007[3]James Graham Brown Cancer Center ( Site 0017) Louisville, Kentucky, United States, 40202[4]Johns Hopkins University ( Site 0052) Baltimore, Maryland, United States, 21224[5]Dana Farber Cancer Center ( Site 0019) Boston, Massachusetts, United States, 02215[6]UMASS Memorial Medical Center ( Site 0020) Worcester, Massachusetts, United States, 01655[7]Henry Ford Health System ( Site 0023) Detroit, Michigan, United States, 48202[8]Cancer and Hematology Centers of Western Michigan ( Site 0025) Grand Rapids, Michigan, United States, 49503[9]Washington University School of Medicine ( Site 0027) Saint Louis, Missouri, United States, 63110[10]Mount Sinai Hospital ( Site 0051) New York, New York, United States, 10029[11]Memorial Sloan Kettering Cancer Center ( Site 0032) New York, New York, United States, 10065[12]AHN West Penn Hospital-AHN Esophageal and Lung Institute ( Site 0058) Pittsburgh, Pennsylvania, United States, 15224[13]IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202) Caba, Buenos Aires, Argentina, C1012AAR[14]Instituto Medico Alexander Fleming ( Site 0208) Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ[15]Fundacion Favaloro ( Site 0201) Buenos Aires, Argentina, C1093AAS[16]Hospital Aleman ( Site 0210) Buenos Aires, Argentina, C1118AAT[17]Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0207) Buenos Aires, Argentina, C1264AAA[18]CEMIC ( Site 0209) Buenos Aires, Argentina, C1431FWO[19]Hospital Privado de Cordoba ( Site 0204) Cordoba, Argentina, X5016KEH[20]Nepean Hospital ( Site 2305) Kingswood, New South Wales, Australia, 2747[21]Wollongong Hospital ( Site 2307) Wollongong, New South Wales, Australia, 2500[22]Royal Brisbane and Women s Hospital ( Site 2304) Herston, Queensland, Australia, 4029[23]Hollywood Private Hospital-Medical Oncology ( Site 2308) Nedlands, Western Australia, Australia, 6009[24]CHU UCL Namur Site de Godinne ( Site 1005) Yvoir, Namur, Belgium, 5530[25]UZ Gent ( Site 1002) Gent, Oost-Vlaanderen, Belgium, 9000[26]UZ Leuven ( Site 1004) Leuven, Vlaams-Brabant, Belgium, 3000[27]AZ Delta ( Site 1006) Roeselare, West-Vlaanderen, Belgium, 8800[28]Queen Elizabeth II Health Sciences Centre ( Site 0101) Halifax, Nova Scotia, Canada, B3H 2Y9[29]Hamilton Health Sciences - Juravinski Site ( Site 0106) Hamilton, Ontario, Canada, L8V 5C2[30]CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103) Sherbrooke, Quebec, Canada, J1H 5N4[31]Centro Investigación del Cáncer James Lind ( Site 0414) Temuco, Araucania, Chile, 4800827[32]IC La Serena Research ( Site 0410) La Serena, Coquimbo, Chile, 1720430[33]Clinica Universidad Catolica del Maule ( Site 0411) Talca, Maule, Chile, 3460000[34]Fundacion Arturo Lopez Perez FALP ( Site 0403) Santiago, Region M. De Santiago, Chile, 7500836[35]Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407) Santiago, Region M. De Santiago, Chile, 7550000[36]Bradfordhill ( Site 0404) Santiago, Region M. De Santiago, Chile, 8420383[37]Anhui Provincial Hospital ( Site 2415) Hefei, Anhui, China, 230001[38]Cancer Hospital Chinese Academy of Medical Sciences ( Site 2403) Beijing, Beijing, China, 100021[39]Beijing Cancer Hospital ( Site 2453) Beijing, Beijing, China, 100035[40]Fujian Provincial Cancer Hospital ( Site 2408) Fuzhou, Fujian, China, 350014[41]The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si Fuzhou, Fujian, China, 350025[42]The First Affiliated Hospital of Xiamen University ( Site 2420) Xiamen, Fujian, China, 361003[43]The First Affiliated Hospital of Xiamen University ( Site 2446) Xiamen, Fujian, China, 361003[44]Zhongshan Hospital Affiliated to Xiamen University ( Site 2421) Xiamen, Fujian, China, 361004[45]First Hospital of Lanzhou University ( Site 2417) Lanzhou, Gansu, China, 730000[46]Nanfang Hospital ( Site 2456) Guangzhou, Guangdong, China, 510000[47]The Affiliated Hospital Of Hainan Medical University-Cancer rehabilitation and palliative treatment Haikou, Hainan, China, 570102[48]Fourth Hospital Of Hebei Medical University ( Site 2441) Shijiazhuang, Hebei, China, 050011河北医科大学第四医院[49]Harbin Medical University Cancer Hospital ( Site 2410) Harbin, Heilongjiang, China, 150081
The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer.
The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.
