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Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.

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研究单位: [1]Amgen [2]Mayo Clinic - Arizona,Phoenix,Arizona,United States,85054 [3]The Oncology Institute Clinical Research,Cerritos,California,United States,90703 [4]Cancer and Blood Specialty Clinic,Downey,California,United States,90241 [5]City of Hope National Medical Center,Duarte,California,United States,91010 [6]University of California Los Angeles,Los Angeles,California,United States,90095 [7]University of California Irvine,Orange,California,United States,92868 [8]Torrance Memorial Physician Network,Redondo Beach,California,United States,90277 [9]Translational Research in Oncology - US Inc,Santa Monica,California,United States,90404 [10]Translational Research in Oncology US Inc, Trio Central Pharmacy,Santa Monica,California,United States,90404 [11]Olive View-University of California in Los Angeles Medical Center,Sylmar,California,United States,91342 [12]Presbyterian Intercommunity Hospital Health Whitter Hospital,Whittier,California,United States,90602 [13]Yale New Haven Hospital Yale Cancer Center,New Haven,Connecticut,United States,06520 [14]Florida Cancer Specialists - Fort Myers,Fort Myers,Florida,United States,33901 [15]Mayo Clinic,Jacksonville,Florida,United States,32224 [16]Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando,Orlando,Florida,United States,32804 [17]Orlando Health Cancer Institute,Orlando,Florida,United States,32806 [18]University of Illinois Chicago,Chicago,Illinois,United States,60612 [19]Greater Baltimore Medical Center,Baltimore,Maryland,United States,21204 [20]Henry Ford Health System,Detroit,Michigan,United States,48202 [21]Mayo Clinic,Rochester,Minnesota,United States,55905 [22]Summit Medical Group,Florham Park,New Jersey,United States,07932 [23]Memorial Sloan Kettering Cancer Center,New York,New York,United States,10022 [24]Stony Brook University Medical Center,Stony Brook,New York,United States,11794-7263 [25]FirstHealth Cancer Center,Pinehurst,North Carolina,United States,28374 [26]Gabrail Cancer Center, LLC,Canton,Ohio,United States,44718 [27]Providence Portland Medical Center,Portland,Oregon,United States,97213 [28]Saint Lukes University Health Network,Allentown,Pennsylvania,United States,18104 [29]Medical University of South Carolina,Charleston,South Carolina,United States,29425 [30]West Cancer Center,Germantown,Tennessee,United States,38138 [31]Sarah Cannon Research Institute,Nashville,Tennessee,United States,37203 [32]Texas Oncology Central-South,Austin,Texas,United States,78705 [33]University of Texas MD Anderson Cancer Center,Houston,Texas,United States,77030 [34]United States Oncology Regulatory Affairs Corporate Office,The Woodlands,Texas,United States,77380 [35]US Oncology Research Investigational Products Center,The Woodlands,Texas,United States,77380 [36]Virginia Oncology Associates,Norfolk,Virginia,United States,23502 [37]Northwest Cancer Specialists - Vancouver,Vancouver,Washington,United States,98684 [38]Aurora Health Care Metro Inc,Milwaukee,Wisconsin,United States,53215 [39]Cemic,Ciudad Autonoma de Buenos Aires,Buenos Aires,Argentina,C1431FWO [40]Hospital Italiano de La Plata,La Plata,Buenos Aires,Argentina,1900 [41]Centro Medico Austral,Ciudad Autónoma de Buenos Aires,Distrito Federal,Argentina,C1019ABS [42]Fundacion Ars Medica,San Salvador de Jujuy,Jujuy,Argentina,4600 [43]Clinica Viedma,Viedma,Río Negro,Argentina,8500 [44]Hospital Provincial del Centenario,Rosario,Santa Fe,Argentina,S2002KDS [45]Exelsus Oncologia Clinica,San Miguel de Tucuman,Tucuman,Argentina,4000 [46]Fundacion Respirar,Buenos Aires,Argentina,C1426ABP [47]Hospital Italiano,Capital Federal,Argentina,C1199ABB [48]Sanatorio Allende,Córdoba,Argentina,X5000JHQ [49]Hospital Privado Universitario de Cordoba,Córdoba,Argentina,X5016KEH [50]Centro Oncologico Riojano Integral,La Rioja,Argentina,F5300COE [51]GenesisCare -North Shore Oncology,St Leonards,New South Wales,Australia,2065 [52]Calvary Mater Newcastle Hospital,Waratah,New South Wales,Australia,2298 [53]The Queen Elizabeth Hospital,Woodville South,South Australia,Australia,5011 [54]Grampians Health,Ballarat,Victoria,Australia,3350 [55]Austin Health, Austin Hospital,Heidelberg,Victoria,Australia,3084 [56]Medizinische Universitaet Graz,Graz,Austria,8036 [57]Medizinische Universitaet Innsbruck,Innsbruck,Austria,6020 [58]Landeskrankenhaus Feldkirch,Rankweil,Austria,6830 [59]Landeskrankenhaus Salzburg,Salzburg,Austria,5020 [60]Krankenhaus Wiener Neustadt,Wiener Neustadt,Austria,2700 [61]Sichuan Cancer Hospital,Chengdu,Sichuan,China,610041

关键词: Bemarituzumab AMG 552 5-Fluorouracil Leucovorin and Oxaliplatin (mFOLFOX6) Nivolumab Gastric Cancer Gastroesophageal Junction Adenocarcinoma FGFR2b Overexpression Capecitabine and Oxaliplatin (CAPOX)

研究目的:
The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab. The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.

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