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

NCT ID: NCT05111626

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

515 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-14

Study Completion Date

2027-01-29

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Gastroesophageal Junction Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This is a Phase 1b/3 study:

* Phase 1b (Part 1) is a single-arm open-label study, which will enroll about 20 participants
* Phase 3 (Part 2) is a randomized double-blind 2-arm study, which will enroll 508 participants
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and Nivolumab

Participants will be administered bemarituzumab at different doses with mFOLFOX6 and nivolumab to determine the recommended phase 3 dose (RP3D) based on occurrence of dose-limiting toxicities (DLTs), and on an evaluation of the overall safety, tolerability, and pharmacokinetics (PK).

Group Type EXPERIMENTAL

Bemarituzumab

Intervention Type DRUG

Bemarituzumab will be administered as intravenous (IV) infusion.

Nivolumab

Intervention Type DRUG

Nivolumab will be administered as IV infusion.

Chemotherapy

Intervention Type DRUG

mFOLFOX6: 5-fluorouracil, leucovorin, and oxaliplatin will be administered as IV infusion.

OR CAPOX: oxaliplatin will be administered as IV infusion and capecitabine will be administered orally.

Part 2: Bemarituzumab with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab

Participants will be administered bemarituzumab at the RP3D determined from Part 1 in combination with mFOLFOX6 and nivolumab on a 14-day cycle.

Or participants will be administered bemarituzumab in combination with CAPOX and nivolumab on a 21-day cycle.

Group Type EXPERIMENTAL

Bemarituzumab

Intervention Type DRUG

Bemarituzumab will be administered as intravenous (IV) infusion.

Nivolumab

Intervention Type DRUG

Nivolumab will be administered as IV infusion.

Chemotherapy

Intervention Type DRUG

mFOLFOX6: 5-fluorouracil, leucovorin, and oxaliplatin will be administered as IV infusion.

OR CAPOX: oxaliplatin will be administered as IV infusion and capecitabine will be administered orally.

Part 2: Placebo with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab

Participants will be administered placebo comparator in combination with mFOLFOX6 and nivolumab on a 14-day cycle.

Or participants will be administered placebo comparator in combination with CAPOX and nivolumab on a 21-day cycle.

Group Type PLACEBO_COMPARATOR

Nivolumab

Intervention Type DRUG

Nivolumab will be administered as IV infusion.

Chemotherapy

Intervention Type DRUG

mFOLFOX6: 5-fluorouracil, leucovorin, and oxaliplatin will be administered as IV infusion.

OR CAPOX: oxaliplatin will be administered as IV infusion and capecitabine will be administered orally.

Placebo

Intervention Type OTHER

Placebo will be administered as IV infusion.

Interventions

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Bemarituzumab

Bemarituzumab will be administered as intravenous (IV) infusion.

Intervention Type DRUG

Nivolumab

Nivolumab will be administered as IV infusion.

Intervention Type DRUG

Chemotherapy

mFOLFOX6: 5-fluorouracil, leucovorin, and oxaliplatin will be administered as IV infusion.

OR CAPOX: oxaliplatin will be administered as IV infusion and capecitabine will be administered orally.

Intervention Type DRUG

Placebo

Placebo will be administered as IV infusion.

Intervention Type OTHER

Other Intervention Names

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AMG 552

Eligibility Criteria

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Inclusion Criteria

* Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
* Participant has no contraindications to nivolumab and either mFOLFOX6 or CAPOX chemotherapy as per local prescribing information. Participants in Part 1 must have no contraindications to mFOLFOX6. Participants in Part 2 with contraindications to mFOLFOX6 are permitted and may be administered the CAPOX regimen, if no contraindications for this regimen exist. Participants in Part 2 with contraindications to CAPOX are permitted and may be administered the mFOLFOX6 regimen, if no contraindications for this regimen exist
* Adequate organ function as follows:

* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Platelet count ≥ 100 x 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 aminotransaminase (AST) and Alanine aminotransaminase (ALT) \<3 x upper limit of normal (ULN) (or \< 5 x ULN if liver involvement)
* Total bilirubin \<1.5 x ULN (or \< 2 x ULN if liver involvement or Gilbert's disease)
* Part 1 only: Calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/minute calculated using the formula of Cockcroft and Gault (\[140 - Age\] × Mass \[kg\]/\[72 × Creatinine mg/dL\]) (x 0.85 if female).
* Part 2 only: 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).
* INR or prothrombin time (PT) \< 1.5 × ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment


* No prior treatment for metastatic or unresectable disease except for a maximum of

1 dose of chemotherapy with or without nivolumab; prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment
* Fibroblast growth factor receptor 2b (FGFR2b) ≥ 10% 2+/3+ tumor cells (TC) 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.

Exclusion Criteria

* Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
* Known positive human epidermal growth factor receptor 2 (HER2) status
* Untreated or symptomatic central nervous system disease metastases and leptomeningeal disease
* Peripheral sensory neuropathy grade 2 or higher
* Clinically significant cardiac disease
* Other malignancy within the last 2 years (exceptions for definitively treated disease)
* Chronic or systemic ophthalmologic disorders
* Major surgery or other investigational study within 28 days prior to randomization
* Palliative radiotherapy within 14 days prior to randomization
* Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
* Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Mayo Clinic - Arizona

Phoenix, Arizona, United States

Site Status

The Oncology Institute Clinical Research

Cerritos, California, United States

Site Status

Cancer and Blood Specialty Clinic

Downey, California, United States

Site Status

City of Hope National Medical Center

Duarte, California, United States

Site Status

University of California Los Angeles

Los Angeles, California, United States

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University of California Irvine

Orange, California, United States

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Torrance Memorial Physician Network

Redondo Beach, California, United States

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Translational Research in Oncology - US Inc

Santa Monica, California, United States

Site Status

Translational Research in Oncology US Inc, Trio Central Pharmacy

Santa Monica, California, United States

Site Status

Olive View-University of California in Los Angeles Medical Center

Sylmar, California, United States

Site Status

Presbyterian Intercommunity Hospital Health Whitter Hospital

Whittier, California, United States

Site Status

Yale New Haven Hospital Yale Cancer Center

New Haven, Connecticut, United States

Site Status

Florida Cancer Specialists - Fort Myers

Fort Myers, Florida, United States

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Mayo Clinic

Jacksonville, Florida, United States

Site Status

Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando

Orlando, Florida, United States

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Orlando Health Cancer Institute

Orlando, Florida, United States

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University of Illinois Chicago

Chicago, Illinois, United States

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Greater Baltimore Medical Center

Baltimore, Maryland, United States

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Henry Ford Health System

Detroit, Michigan, United States

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Mayo Clinic

Rochester, Minnesota, United States

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Summit Medical Group

Florham Park, New Jersey, United States

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

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Stony Brook University Medical Center

Stony Brook, New York, United States

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FirstHealth Cancer Center

Pinehurst, North Carolina, United States

Site Status

Gabrail Cancer Center, LLC

Canton, Ohio, United States

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Providence Cancer Institute Franz Clinic

Portland, Oregon, United States

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Saint Lukes University Health Network

Allentown, Pennsylvania, United States

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Medical University of South Carolina

Charleston, South Carolina, United States

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West Cancer Center

Germantown, Tennessee, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

Texas Oncology Central-South

Austin, Texas, United States

Site Status

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

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United States Oncology Regulatory Affairs Corporate Office

The Woodlands, Texas, United States

Site Status

US Oncology Research Investigational Products Center

The Woodlands, Texas, United States

Site Status

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status

Northwest Cancer Specialists - Vancouver

Vancouver, Washington, United States

Site Status

Aurora Health Care Metro Inc

Milwaukee, Wisconsin, United States

Site Status

Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

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Centro Medico Austral

Buenos Aires, Distrito Federal, Argentina

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Fundacion Ars Medica

San Salvador de Jujuy, Jujuy Province, Argentina

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Clinica Viedma

Viedma, Río Negro Province, Argentina

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Hospital Provincial del Centenario

Rosario, Santa Fe Province, Argentina

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Exelsus Oncologia Clinica

San Miguel de Tucumán, Tucumán Province, Argentina

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Fundacion Respirar

Buenos Aires, , Argentina

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Hospital Italiano

Capital Federal, , Argentina

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Sanatorio Allende

Córdoba, , Argentina

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Hospital Privado Universitario de Cordoba

Córdoba, , Argentina

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Centro Oncologico Riojano Integral

La Rioja, , Argentina

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GenesisCare -North Shore Oncology

St Leonards, New South Wales, Australia

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Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

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The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

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Grampians Health

Ballarat, Victoria, Australia

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Austin Health, Austin Hospital

Heidelberg, Victoria, Australia

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Medizinische Universitaet Graz

Graz, , Austria

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Medizinische Universitaet Innsbruck

Innsbruck, , Austria

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Landeskrankenhaus Feldkirch

Rankweil, , Austria

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Landeskrankenhaus Salzburg

Salzburg, , Austria

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Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, , Austria

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Krankenhaus Wiener Neustadt

Wiener Neustadt, , Austria

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Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, , Belgium

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Institut Jules Bordet

Brussels, , Belgium

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Grand Hopital de Charleroi

Charleroi, , Belgium

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Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

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Universitair Ziekenhuis Gent

Ghent, , Belgium

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Universitair Ziekenhuis Brussel

Jette, , Belgium

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Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, , Belgium

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Hopital De Libramont

Libramont, , Belgium

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Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, , Belgium

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Algemeen Ziekenhuis Turnhout Campus Sint-Jozef

Turnhout, , Belgium

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Hospital Haroldo Juacaba - Instituto do Cancer do Ceara

Fortaleza, Ceará, Brazil

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Hospital Evangelico de Cachoeiro de Itapemirim

Cachoeiro de Itapemirim, Espírito Santo, Brazil

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Hospital Sirio Libanes

Brasília, Federal District, Brazil

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Personal Oncologia de Precisao e Personalizada

Belo Horizonte, Minas Gerais, Brazil

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Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, Brazil

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Hospital das Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

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Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, Brazil

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Fundacao Pio 12 Hospital de Amor de Barretos

Barretos, São Paulo, Brazil

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Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

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Instituto do Cancer Arnaldo Vieira de Carvalho

São Paulo, São Paulo, Brazil

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Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, São Paulo, Brazil

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Fundacao Antonio Prudente AC Camargo Cancer Center

São Paulo, São Paulo, Brazil

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Instituto Coi

Rio de Janeiro, , Brazil

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Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp

São Paulo, , Brazil

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Complex Oncology Center - Burgas

Burgas, , Bulgaria

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Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD

Haskovo, , Bulgaria

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Multiprofile Hospital for Active Treatment - Uni Hospital OOD

Panagyurishte, , Bulgaria

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Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

Plovdiv, , Bulgaria

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Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

Sofia, , Bulgaria

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Multiprofile Hospital for Active Treatment Serdika EOOD

Sofia, , Bulgaria

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London Health Sciences Centre

London, Ontario, Canada

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Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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Sunnybrook Research Institute Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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Centre Hospitalier de L Universite de Montreal

Montreal, Quebec, Canada

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Jewish General Hospital

Montreal, Quebec, Canada

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CHU de Quebec Hopital de l Enfant Jesus

Québec, Quebec, Canada

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Oncocentro Apys

Viña del Mar, Región de Valparaíso, Chile

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Centro De Estudios Clínicos Suecia SpA

Santiago, Santiago Metropolitan, Chile

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IC La Serena Research

La Serena, , Chile

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Centro de Estudios Clinicos SAGA Spa

Santiago, , Chile

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Oncovida

Santiago, , Chile

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Icegclinic

Santiago, , Chile

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Centro de Estudios Clinicos e Investigaciones Medicas CeCim

Santiago, , Chile

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The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

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The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

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Anhui Provincial Cancer Hospital

Hefei, Anhui, China

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Cancer Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

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Fujian Cancer Hospital

Fuzhou, Fujian, China

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The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

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Lanzhou University Second Hospital

Lanzhou, Gansu, China

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Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

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Gansu Wuwei Tumour Hospital

Wuwei, Gansu, China

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The first people's Hospital of Foshan

Foshan, Guangdong, China

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China

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Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

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Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

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The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

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Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

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Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

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The First Affiliated Hospital of Henan University of science and Technology

Luoyang, Henan, China

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Henan Cancer Hospital

Zhengzhou, Henan, China

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The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Taihe Hospital Affiliated Hospital of Hubei University of Medicine

Shiyan, Hubei, China

Site Status

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Tongji Hospital Tongji Medical College Of Hust

Wuhan, Hubei, China

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Hubei Cancer Hospital

Wuhan, Hubei, China

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The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

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Xiangya Hospital of Central South University

Changsha, Hunan, China

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Hunan Cancer Hospital

Changsha, Hunan, China

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Inner Mongolia Autonomous Region Peoples Hospital

Hohhot, Inner Mongolia, China

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The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

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Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

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Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

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The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

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The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

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Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

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Northern Jiangsu Peoples Hospital

Yangzhou, Jiangsu, China

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The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Site Status

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

Site Status

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Site Status

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

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The First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

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Shaanxi Provincial People Hospital

Xi'an, Shaanxi, China

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Qilu Hospital of Shandong University

Jinan, Shandong, China

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The Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

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Affiliated Hospital of Jining Medical University

Jining, Shandong, China

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The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

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Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

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Shanghai East Hospital

Shanghai, Shanghai Municipality, China

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Changzhi Peoples Hospital

Changzhi, Shanxi, China

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Linfen Central Hospital

Linfen, Shanxi, China

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Sichuan Cancer Hospital

Chengdu, Sichuan, China

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West China Hospital of Sichuan University

Chengdu, Sichuan, China

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The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

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Tianjin Medical University Cancer institute and hospital

Tianjin, Tianjin Municipality, China

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Yunnan Cancer Hospital

Kunming, Yunnan, China

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The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, China

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Lishui Municipal central Hospital

Lishui, Zhejiang, China

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The First Affiliate Hospital of Ningbo University

Ningbo, Zhejiang, China

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Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

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Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA

Rionegro, Antioquia, Colombia

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Sociedad de Oncologia y Hematologia del Cesar

Valledupar, Cesar Department, Colombia

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Fundacion Cardiovascular de Colombia

Bucaramanga, Santander Department, Colombia

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Fundacion Oftalmologica de Santander - Foscal

Floridablanca, Santander Department, Colombia

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Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

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Fakultni nemocnice Olomouc

Olomouc, , Czechia

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Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

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Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

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Fakultni Thomayerova nemocnice

Prague, , Czechia

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Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud

Amiens, , France

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Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz

Besançon, , France

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Institut Bergonie

Bordeaux, , France

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Centre Hospitalier Universitaire de Brest - Cavale Blanche

Brest, , France

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Centre Hospitalier Universitaire de Clermont Ferrand, Hopital Estaing

Clermont-Ferrand, , France

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Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

Lille, , France

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Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren

Limoges, , France

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Centre Leon Berard

Lyon, , France

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Centre Antoine Lacassagne

Nice, , France

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Hopital Europeen Georges Pompidou

Paris, , France

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Hopital Saint Louis

Paris, , France

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Institut Mutualiste Montsouris

Paris, , France

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Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, , France

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Centre Hospitalier Universitaire de Rouen

Rouen, , France

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Centre Rene Gauducheau - Institut de Cancerologie de l Ouest

Saint-Herblain, , France

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Centre Hospitalier Universitaire Nord de Saint Etienne - Hopital Nord

Saint-Priest-en-Jarez, , France

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Institut de cancerologie Strasbourg Europe

Strasbourg, , France

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Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

Toulouse, , France

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Institut Gustave Roussy

Villejuif, , France

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Charite - Universitaetsmedizin Berlin, Campus Virchow

Berlin, , Germany

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Universitaetsklinikum Dresden

Dresden, , Germany

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Krankenhaus Nordwest GmbH

Frankfurt am Main, , Germany

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Haematologisch Onkologische Praxis Eppendorf

Hamburg, , Germany

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Medizinische Hochschule Hannover

Hanover, , Germany

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Universitaetsklinikum Schleswig-Holstein

Kiel, , Germany

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Universitaetsklinikum Leipzig

Leipzig, , Germany

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Regional Kliniken Holding Klinikum Ludwigsburg

Ludwigsburg, , Germany

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Johannes Gutenberg Universitaet Mainz

Mainz, , Germany

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Universitaetsmedizin Mannheim

Mannheim, , Germany

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Klinikum der LMU Muenchen

München, , Germany

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Klinikum rechts der Isar der TUM

München, , Germany

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Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen

Tübingen, , Germany

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Universitaetsklinikum Ulm

Ulm, , Germany

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Klinikum der Stadt Wolfsburg

Wolfsburg, , Germany

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Prince of Wales Hospital / CUHK

Shatin, New Territories, , Hong Kong

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Semmelweis Egyetem

Budapest, , Hungary

Site Status

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

Budapest, , Hungary

Site Status

Orszagos Onkologiai Intezet

Budapest, , Hungary

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Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Site Status

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

Nyíregyháza, , Hungary

Site Status

Tolna Varmegyei Balassa Janos Korhaz

Szekszárd, , Hungary

Site Status

Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet

Szolnok, , Hungary

Site Status

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, , Hungary

Site Status

Rambam Health Care Campus

Haifa, , Israel

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Shaare Zedek Medical Center

Jerusalem, , Israel

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Hadassah Ein-Kerem Medical Center

Jerusalem, , Israel

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Sheba Medical Center

Ramat Gan, , Israel

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Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

Ancona, , Italy

Site Status

Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii

Bergamo, , Italy

Site Status

Istituto Ospedaliero Fondazione Poliambulanza

Brescia, , Italy

Site Status

Ente Ospedaliero IRCCS Saverio De Bellis

Castellana Grotte, , Italy

Site Status

Azienda Socio Sanitaria Territoriale di Cremona

Cremona, , Italy

Site Status

Azienda Ospedaliero Universitaria Careggi

Florence, , Italy

Site Status

Ospedale Policlinico San Martino IRCCS

Genova, , Italy

Site Status

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Site Status

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status

Azienda Ospedaliero Universitaria Luigi Vanvitelli

Napoli, , Italy

Site Status

Istituto Nazionale dei Tumori IRCCS Fondazione Giovanni Pascale

Napoli, , Italy

Site Status

Istituto Oncologico Veneto IRCCS

Padua, , Italy

Site Status

Azienda Ospedaliera Universitaria Pisana

Pisa, , Italy

Site Status

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Site Status

Chiba Cancer Center

Chiba, Chiba, Japan

Site Status

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Site Status

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Site Status

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Site Status

Gifu University Hospital

Gifu, Gifu, Japan

Site Status

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Site Status

Hyogo Cancer Center

Akashi-shi, Hyōgo, Japan

Site Status

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Site Status

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Site Status

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Site Status

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Site Status

Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

Site Status

Osaka International Cancer Institute

Osaka, Osaka, Japan

Site Status

Kindai University Hospital

Osakasayama-shi, Osaka, Japan

Site Status

Osaka University Hospital

Suita-shi, Osaka, Japan

Site Status

Saitama Cancer Center

Kitaadachi-gun, Saitama, Japan

Site Status

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

Site Status

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Site Status

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan

Site Status

Beskidzkie Centrum Onkologii Szpital Miejski imienia Jana Pawla Drugiego

Bielsko-Biala, , Poland

Site Status

Narodowy Instytut Onkologii im M Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach

Gliwice, , Poland

Site Status

Przychodnia Lekarska Komed Roman Karaszewski

Konin, , Poland

Site Status

Samodzielny Publiczny Szpital Kliniczny Nr 1

Lublin, , Poland

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Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji

Olsztyn, , Poland

Site Status

Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo

Siedlce, , Poland

Site Status

Centrum Medyczne Pratia Poznan

Skorzewo, , Poland

Site Status

Uniwersytecki Szpital Kliniczny nr 1 im prof Tadeusza Sokolowskiego Pum w Szczecinie

Szczecin, , Poland

Site Status

Lux med onkologia sp zoo szpital szamocka

Warsaw, , Poland

Site Status

Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Warsaw, , Poland

Site Status

Mtz Clinical Research powered by Pratia

Warsaw, , Poland

Site Status

Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, , Poland

Site Status

Unidade Local de Saude de Braga, EPE

Braga, , Portugal

Site Status

Unidade Local de Saude do Alto Ave, EPE

Guimarães, , Portugal

Site Status

Hospital da Luz, SA

Lisbon, , Portugal

Site Status

Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, , Portugal

Site Status

Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

Matosinhos Municipality, , Portugal

Site Status

Hospital Cuf porto

Porto, , Portugal

Site Status

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

Porto, , Portugal

Site Status

Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao

Porto, , Portugal

Site Status

Institutul Clinic Fundeni

Bucharest, , Romania

Site Status

Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor

Cluj-Napoca, , Romania

Site Status

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, , Romania

Site Status

Centrul de Oncologie Sf Nectarie SRL

Craiova, , Romania

Site Status

Institutul Regional de Oncologie Iasi

Iași, , Romania

Site Status

Spitalul Municipal Ploiesti

Ploieşti, , Romania

Site Status

SC Oncomed SRL

Timișoara, , Romania

Site Status

National University Hospital

Singapore, , Singapore

Site Status

National Cancer Centre Singapore

Singapore, , Singapore

Site Status

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

National Cancer Center

Goyang-si Gyeonggi-do, , South Korea

Site Status

Jeonbuk National University Hospital

Jeonju-si, Jeollabuk-do, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Severance Hospital Yonsei University Health System

Seoul, , South Korea

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Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

The Catholic University of Korea Seoul St Marys Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Hospital Universitario Virgen del Rocio

Seville, Andalusia, Spain

Site Status

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Site Status

Hospital del Mar

Barcelona, Catalonia, Spain

Site Status

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Site Status

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, Spain

Site Status

Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

L'Hospitalet de Llobregat, Catalonia, Spain

Site Status

Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera

A Coruña, Galicia, Spain

Site Status

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status

Hospital General Universitario de Elche

Elche, Valencia, Spain

Site Status

Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain

Site Status

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Site Status

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Site Status

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Universitaetsspital Basel

Basel, , Switzerland

Site Status

Inselspital Bern

Bern, , Switzerland

Site Status

Kantonsspital Graubuenden

Chur, , Switzerland

Site Status

Hopitaux Universitaires de Geneve

Geneva, , Switzerland

Site Status

Onkozentrum Zuerich

Zurich, , Switzerland

Site Status

Universitaetsspital Zuerich

Zurich, , Switzerland

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Tri-Service General Hospital

Taipei, , Taiwan

Site Status

Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

Taoyuan District, , Taiwan

Site Status

Chulabhorn Hospital

Bangkok, , Thailand

Site Status

Siriraj Hospital

Bangkok, , Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, , Thailand

Site Status

Chiangrai Prachanukroh Hospital

Chiang Rai, , Thailand

Site Status

Prince of Songkla Hospital

Songkhla, , Thailand

Site Status

Addenbrookes Hospital

Cambridge, , United Kingdom

Site Status

University Hospital Coventry

Coventry, , United Kingdom

Site Status

Ninewells Hospital and Medical School

Dundee, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Guys Hospital

London, , United Kingdom

Site Status

Christie Hospital

Manchester, , United Kingdom

Site Status

Mount Vernon Cancer Centre

Northwood, , United Kingdom

Site Status

Churchill Hospital

Oxford, , United Kingdom

Site Status

Southampton General Hospital

Southampton, , United Kingdom

Site Status

Torbay Hospital

Torquay, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile China Colombia Czechia France Germany Hong Kong Hungary Israel Italy Japan Poland Portugal Romania Singapore South Korea Spain Switzerland Taiwan Thailand United Kingdom

References

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Wainberg ZA, Kang YK, Lee KW, Qin S, Yamaguchi K, Kim IH, Saeed A, Oh SC, Li J, Turk HM, Teixeira A, Hitre E, Udrea AA, Cardellino GG, Sanchez RG, Zahlten-Kumeli A, Taylor K, Enzinger PC. Bemarituzumab as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma: final analysis of the randomized phase 2 FIGHT trial. Gastric Cancer. 2024 May;27(3):558-570. doi: 10.1007/s10120-024-01466-w. Epub 2024 Feb 3.

Reference Type DERIVED
PMID: 38308771 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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2023-505458-16

Identifier Type: REGISTRY

Identifier Source: secondary_id

20210098

Identifier Type: -

Identifier Source: org_study_id

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