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Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
Sponsor: Amgen
Summary
The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)
Official title: A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
547
Start Date
2022-03-07
Completion Date
2026-04-26
Last Updated
2026-10-23
Healthy Volunteers
No
Interventions
Bemarituzumab
Intravenous (IV) infusion
mFOLFOX6
mFOLFOX6 administered as a combination of oxaliplatin and leucovorin as IV infusions. 5-FU administered as bolus followed by additional administration as IV infusion.
Placebo
IV infusion
Locations (300)
Alaska Oncology and Hematology
Anchorage, Alaska, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
The Oncology Institute Clinical Research
Cerritos, California, United States
University of California Los Angeles
Los Angeles, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Saint Francis Medical Group
Indianapolis, Indiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Healthier Hematology and Oncology Excelsior Integrated Medical Group
Brooklyn, New York, United States
White Plains Hospital Center for Cancer Care
White Plains, New York, United States
Levine Cancer Institute University
Charlotte, North Carolina, United States
FirstHealth Cancer Center
Pinehurst, North Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Medical Oncology Associates, PS
Spokane, Washington, United States
Instituto Alexander Fleming
CABA, Buenos Aires, Argentina
Hospital Universitario Fundacion Favaloro
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Sociedad de Beneficencia Hospital Italiano
Córdoba, Córdoba Province, Argentina
Hospital Privado Universitario de Cordoba
Córdoba, Córdoba Province, Argentina
Hospital Provincial del Centenario
Rosario, Santa Fe Province, Argentina
Exelsus Oncologia Clinica
San Miguel de Tucumán, Tucumán Province, Argentina
Instituto Argentino de Diagnostico y Tratamiento IADT
Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, Argentina
Liverpool Hospital
Liverpool, New South Wales, Australia
St John of God Murdoch Hospital
Murdoch, Western Australia, Australia
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, Belgium
Núcleo de Oncologia da Bahia
Salvador, Estado de Bahia, Brazil
Centro de Oncologia Mackenzie
Curitiba, Paraná, Brazil
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Oncologia Reichow
Blumenau, Santa Catarina, Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
Florianópolis, Santa Catarina, Brazil
Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas
Santo André, São Paulo, Brazil
Instituto Nacional de Cancer
Rio de Janeiro, Brazil
Hospital Nove de Julho - dasa
São Paulo, Brazil
Instituto Brasileiro de Controle do Cancer Ibcc
São Paulo, Brazil
Multiprofile Hospital for Active Treatment Park Hospital EOOD
Branipole Village, Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
Haskovo, Bulgaria
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
Pleven, Bulgaria
University Multiprofile Hospital for Active Treatment Pulmed OOD
Plovdiv, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia, Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, Bulgaria
Cross Cancer Institute
Edmonton, Alberta, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Sunnybrook Research Institute Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
James Lind Centro de Investigacion del Cancer
Temuco, Cautín, Chile
Clinica CIDO
Temuco, Cautín, Chile
Centro de Estudios Clinicos SAGA Spa
Santiago, Chile
Centro de Estudios Clinicos e Investigaciones Medicas CeCim
Santiago, Chile
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of ScienceandTechnology
Wuhan, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Anyang Cancer Hospital
Anyang, Henan, China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Taihe Hospital Affiliated Hospital of Hubei University of Medicine
Shiyan, Hubei, China
The Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and Tech
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi an Jiaotong University
Xi'an, Shaanxi, China
Jinan Central Hospital
Jinan, Shandong, China
The Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China