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