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ACTIVE NOT RECRUITING

NCT05052801

PHASE3

Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

Sponsor: Amgen

View on ClinicalTrials.gov

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

2026-06-20

Last Updated

2026-02-19

Healthy Volunteers

Conditions

Gastric Cancer Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

Bemarituzumab

Intravenous (IV) infusion

DRUG

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.

DRUG

Placebo

IV infusion

Inclusion Criteria: * Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy * Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy * Eastern Cooperative Oncology Group (ECOG) less than or equal to 1 * Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1 * Participant has no contraindications to mFOLFOX6 chemotherapy * Adequate organ and bone marrow function: * absolute neutrophil count greater than or equal to 1.5 times 10\^9/L * platelet count greater than or equal to 100 times 10\^9/L * hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment * aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease) * calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault (\[140 - Age\]) × Mass \[kg\]/\[72 × Creatinine mg/dL\]) (x 0.85 if female) * international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment Exclusion Criteria: * Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment) * Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway * Known human epidermal growth factor receptor 2 (HER2) positive * Untreated or symptomatic central nervous system (CNS) disease or brain metastases * Peripheral sensory neuropathy greater than or equal to Grade 2 * Clinically significant cardiac disease * Other malignancy within the last 2 years (exceptions for definitively treated disease) * Chronic or systemic ophthalmological disorders * Major surgery or other investigational study within 28 days prior to first dose of study treatment * Palliative radiotherapy within 14 days prior to the first dose of study treatment * Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.

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