Clinical trial NCT05111626: Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.
Official title: A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Keywords: Bemarituzumab
AMG 552
5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6)
Nivolumab
Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
FGFR2b Overexpression
Capecitabine and Oxaliplatin (CAPOX)
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-11-08
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria Part 1 and Part 2:

* 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

Additional Inclusion Criteria Part 2:

* 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

Primary outcomes:
measure: Part 1: Number of Participants Who Experienced DLTs
timeFrame: 28 days
measure: Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 4.5 years
measure: Part 1: Number of Participants Who Experienced One or More Related TEAEs
timeFrame: Up to 4.5 years
measure: Part 1: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: Up to 4.5 years
measure: Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity
timeFrame: Up to 4.5 years
measure: Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations
timeFrame: Up to 4.5 years
measure: Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
timeFrame: Up to 4.5 years
measure: Part 2: Overall Survival in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
timeFrame: Up to 4.5 years
Secondary outcomes:
measure: Part 1: Objective Response (OR)
timeFrame: Up to 4.5 years
measure: Part 1: Duration of Response (DoR)
timeFrame: Up to 4.5 years
measure: Part 1: Disease Control Rate (DCR)
timeFrame: Up to 4.5 years
measure: Part 1: Progression Free Survival (PFS)
timeFrame: Up to 4.5 years
measure: Part 1: Overall Survival
timeFrame: Up to 4.5 years
measure: Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab
timeFrame: Day 1 to up to 4.5 years
measure: Part 1: Area Under the Concentration Time Curve (AUC) of Bemarituzumab
timeFrame: Day 1 to up to 4.5 years
measure: Part 1: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
timeFrame: Day 1 to up to 4.5 years
measure: Part 1: Number of Participants With Anti-Bemarituzumab Antibody Formation
timeFrame: Day 1 to up to 4.5 years
measure: Part 2: PFS in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
timeFrame: Up to 4.5 years
measure: Part 2: Overall Survival in All Randomized Participants
timeFrame: Up to 4.5 years
measure: Part 2: PFS in All Randomized Participants
timeFrame: Up to 4.5 years
measure: Part 2: Number of Participants Who Experienced One or More TEAEs
timeFrame: Up to 4.5 years
measure: Part 2: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: Up to 4.5 years
measure: Part 2: Number of Participants With Clinically Significant Changes in Visual Acuity
timeFrame: Up to 4.5 years
measure: Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
timeFrame: Up to 4.5 years
measure: Part 2: OR
timeFrame: Up to 4.5 years
measure: Part 2: DoR
timeFrame: Up to 4.5 years
measure: Part 2: DCR
timeFrame: Up to 4.5 years
measure: Part 2: Mean Score in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Version 3.0 (QLQ-C30) Individual Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
timeFrame: Up to 4.5 years
measure: Part 2: Change From Baseline in EORTC QLQ-C30 Individual Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
timeFrame: Baseline to up to 4.5 years
measure: Part 2: Mean Score in Stomach Cancer Related Symptoms Measured by EORTC Quality of Life Questionnaire-Stomach 22 (QLQ-STO22) in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
timeFrame: Up to 4.5 years
measure: Part 2: Change From Baseline in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
timeFrame: Baseline to up to 4.5 years
measure: Part 2: Mean Score of Visual Analogue Scale (VAS) Scores as Measured by EuroQol 5-dimensional (EQ-5D-5L) in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
timeFrame: Up to 4.5 years
measure: Part 2: Change From Baseline of VAS Scores as Measured by EQ-5D-5L in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
timeFrame: Baseline to up to 4.5 years
measure: Part 2: Time to Deterioration in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
timeFrame: Day 1 to up to 4.5 years
measure: Part 2: Time to Deterioration in Health-Related Quality of Life (HRQoL) Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
timeFrame: Day 1 to up to 4.5 years
measure: Part 2: Time to Deterioration in Physical Function Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
timeFrame: Day 1 to up to 4.5 years
measure: Part 2: AUC of Bemarituzumab
timeFrame: Day 1 to up to 4.5 years
measure: Part 2: Cmax of Bemarituzumab
timeFrame: Day 1 to up to 4.5 years
measure: Part 2: Ctrough of Bemarituzumab
timeFrame: Day 1 to up to 4.5 years
measure: Part 2: Number of Participants With Anti-Bemarituzumab Antibody Formation
timeFrame: Day 1 to up to 4.5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic - Arizona
state: Arizona
city: Cerritos
country: United States
facility: The Oncology Institute Clinical Research
state: California
city: Downey
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Redondo Beach
country: United States
facility: Torrance Memorial Physician Network
state: California
city: Santa Monica
country: United States
facility: Translational Research in Oncology - US Inc
state: California
city: Santa Monica
country: United States
facility: Translational Research in Oncology US Inc, Trio Central Pharmacy
state: California
city: Sylmar
country: United States
facility: Olive View-University of California in Los Angeles Medical Center
state: California
city: Whittier
country: United States
facility: Presbyterian Intercommunity Hospital Health Whitter Hospital
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital Yale Cancer Center
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - Fort Myers
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Orlando
country: United States
facility: Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
state: Florida
city: Orlando
country: United States
facility: Orlando Health Cancer Institute
state: Florida
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Pinehurst
country: United States
facility: FirstHealth Cancer Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center, LLC
state: Ohio
city: Portland
country: United States
facility: Providence Cancer Institute Franz Clinic
state: Oregon
city: Allentown
country: United States
facility: Saint Lukes University Health Network
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology Central-South
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: The Woodlands
country: United States
facility: United States Oncology Regulatory Affairs Corporate Office
state: Texas
city: The Woodlands
country: United States
facility: US Oncology Research Investigational Products Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialists - Vancouver
state: Washington
city: Milwaukee
country: United States
facility: Aurora Health Care Metro Inc
state: Wisconsin
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Cemic
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro Medico Austral
state: Distrito Federal
city: San Salvador de Jujuy
country: Argentina
facility: Fundacion Ars Medica
state: Jujuy
city: Viedma
country: Argentina
facility: Clinica Viedma
state: Río Negro
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Exelsus Oncologia Clinica
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Fundacion Respirar
city: Capital Federal
country: Argentina
facility: Hospital Italiano
city: Córdoba
country: Argentina
facility: Sanatorio Allende
city: Córdoba
country: Argentina
facility: Hospital Privado Universitario de Cordoba
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral
city: St Leonards
country: Australia
facility: GenesisCare -North Shore Oncology
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle Hospital
state: New South Wales
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Ballarat
country: Australia
facility: Grampians Health
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health, Austin Hospital
state: Victoria
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
city: Rankweil
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Wiener Neustadt
country: Austria
facility: Krankenhaus Wiener Neustadt
city: Wien
country: Austria
facility: Universitaetsklinikum Allgemeines Krankenhaus Wien
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg
city: Libramont
country: Belgium
facility: Hopital De Libramont
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege - Sart Tilman
city: Turnhout
country: Belgium
facility: Algemeen Ziekenhuis Turnhout Campus Sint-Jozef
city: Fortaleza
country: Brazil
facility: Hospital Haroldo Juacaba - Instituto do Cancer do Ceara
state: Ceará
city: Brasilia
country: Brazil
facility: Hospital Sirio Libanes
state: Distrito Federal
city: Cachoeiro de Itapemirim
country: Brazil
facility: Hospital Evangelico de Cachoeiro de Itapemirim
state: Espírito Santo
city: Belo Horizonte
country: Brazil
facility: Personal Oncologia de Precisao e Personalizada
state: Minas Gerais
city: Natal
country: Brazil
facility: Liga Norte-Riograndense Contra O Cancer
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundacao Pio 12 Hospital de Amor de Barretos
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer Arnaldo Vieira de Carvalho
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente AC Camargo Cancer Center
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Coi
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp
city: Burgas
country: Bulgaria
facility: Complex Oncology Center - Burgas
city: Haskovo
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
city: Panagyurishte
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Uni Hospital OOD
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
city: Sofia
country: Bulgaria
facility: Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Serdika EOOD
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de L Universite de Montreal
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec Hopital de l Enfant Jesus
city: Santiago de Chile
country: Chile
facility: Centro De Estudios Clínicos Suecia SpA
state: Santiago
city: Viña del Mar
country: Chile
facility: Oncocentro Apys
state: Valparaíso
city: La Serena
country: Chile
facility: IC La Serena Research
city: Santiago
country: Chile
facility: Centro de Estudios Clinicos SAGA Spa
city: Santiago
country: Chile
facility: Oncovida
city: Santiago
country: Chile
facility: Icegclinic
city: Santiago
country: Chile
facility: Centro de Estudios Clinicos e Investigaciones Medicas CeCim
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical University
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital of Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Lanzhou
country: China
facility: Gansu Provincial Cancer Hospital
state: Gansu
city: Wuwei
country: China
facility: Gansu Wuwei Tumour Hospital
state: Gansu
city: Foshan
country: China
facility: The first people's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Peoples Hospital
state: Guangdong
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical University
state: Hainan
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of science and Technology
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Shiyan
country: China
facility: Taihe Hospital Affiliated Hospital of Hubei University of Medicine
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College Of Hust
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Hohhot
country: China
facility: Inner Mongolia Autonomous Region Peoples Hospital
state: Inner Mongolia
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Yangzhou
country: China
facility: Affiliated Hospital of Yangzhou University
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu Peoples Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xian
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
city: Xian
country: China
facility: Shaanxi Provincial People Hospital
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: The Affiliated Cancer Hospital of Shandong First Medical University
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Changzhi
country: China
facility: Changzhi Peoples Hospital
state: Shanxi
city: Linfen
country: China
facility: Linfen Central Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer institute and hospital
state: Tianjin
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Lishui
country: China
facility: Lishui Municipal central Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The First Affiliate Hospital of Ningbo University
state: Zhejiang
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
city: Rionegro
country: Colombia
facility: Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
state: Antioquia
city: Valledupar
country: Colombia
facility: Sociedad de Oncologia y Hematologia del Cesar
state: Cesar
city: Bucaramanga
country: Colombia
facility: Fundacion Cardiovascular de Colombia
state: Santander
city: Floridablanca
country: Colombia
facility: Fundacion Oftalmologica de Santander - Foscal
state: Santander
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice
city: Amiens Cedex 1
country: France
facility: Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud
city: Besançon
country: France
facility: Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonie
city: Brest Cedex
country: France
facility: Centre Hospitalier Universitaire de Brest - Cavale Blanche
city: Clermont-Ferrand cedex 1
country: France
facility: Centre Hospitalier Universitaire de Clermont Ferrand, Hopital Estaing
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
city: Limoges Cedex
country: France
facility: Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
city: Lyon cedex 8
country: France
facility: Centre Leon Berard
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris Cedex 10
country: France
facility: Hopital Saint Louis
city: Paris Cedex 14
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Rennes Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
city: Rouen Cedex
country: France
facility: Centre Hospitalier Universitaire de Rouen
city: Saint Herblain
country: France
facility: Centre Rene Gauducheau - Institut de Cancerologie de l Ouest
city: Saint Priest en Jarez
country: France
facility: Centre Hospitalier Universitaire Nord de Saint Etienne - Hopital Nord
city: Strasbourg cedex
country: France
facility: Institut de cancerologie Strasbourg Europe
city: Toulouse Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin, Campus Virchow
city: Dresden
country: Germany
facility: Universitaetsklinikum Dresden
city: Frankfurt am Main
country: Germany
facility: Krankenhaus Nordwest GmbH
city: Hamburg
country: Germany
facility: Haematologisch Onkologische Praxis Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Ludwigsburg
country: Germany
facility: Regional Kliniken Holding Klinikum Ludwigsburg
city: Mainz
country: Germany
facility: Johannes Gutenberg Universitaet Mainz
city: Mannheim
country: Germany
facility: Universitaetsmedizin Mannheim
city: Muenchen
country: Germany
facility: Klinikum der LMU Muenchen
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der TUM
city: Tuebingen
country: Germany
facility: Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Wolfsburg
country: Germany
facility: Klinikum der Stadt Wolfsburg
city: Shatin, New Territories
country: Hong Kong
facility: Prince of Wales Hospital / CUHK
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
city: Szekszard
country: Hungary
facility: Tolna Varmegyei Balassa Janos Korhaz
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
city: Tatabanya
country: Hungary
facility: Komarom-Esztergom Varmegyei Szent Borbala Korhaz
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Ein-Kerem Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
city: Brescia
country: Italy
facility: Istituto Ospedaliero Fondazione Poliambulanza
city: Castellana Grotte
country: Italy
facility: Ente Ospedaliero IRCCS Saverio De Bellis
city: Cremona
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Cremona
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino IRCCS
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: Azienda Ospedaliero Universitaria Luigi Vanvitelli
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori IRCCS Fondazione Giovanni Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Chiba-shi
country: Japan
facility: Chiba Cancer Center
state: Chiba
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama-shi
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu University Hospital
state: Gifu
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Akashi-shi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Yokohama-shi
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
state: Kanagawa
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research
state: Tokyo
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Goyang-si Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Jeonju-si, Jeollabuk-do
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Bielsko-Biala
country: Poland
facility: Beskidzkie Centrum Onkologii Szpital Miejski imienia Jana Pawla Drugiego
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii im M Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed Roman Karaszewski
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Olsztyn
country: Poland
facility: Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Szczecin
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 1 im prof Tadeusza Sokolowskiego Pum w Szczecinie
city: Warszawa
country: Poland
facility: Lux med onkologia sp zoo szpital szamocka
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
city: Warszawa
country: Poland
facility: Mtz Clinical Research powered by Pratia
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu
city: Braga
country: Portugal
facility: Unidade Local de Saude de Braga, EPE
city: Guimaraes
country: Portugal
facility: Unidade Local de Saude do Alto Ave, EPE
city: Lisboa
country: Portugal
facility: Hospital da Luz, SA
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
city: Matosinhos
country: Portugal
facility: Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
city: Porto
country: Portugal
facility: Hospital Cuf porto
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
city: Porto
country: Portugal
facility: Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
city: Cluj-Napoca
country: Romania
facility: Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf Nectarie SRL
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti
city: Timisoara
country: Romania
facility: SC Oncomed SRL
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Andalucía
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
state: Cataluña
city: Hospitalet de Llobregat
country: Spain
facility: Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
state: Cataluña
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
state: Comunidad Valenciana
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
state: Galicia
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich
city: Zurich
country: Switzerland
facility: Onkozentrum Zuerich
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
city: Bangkok
country: Thailand
facility: Chulabhorn Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Chiang Rai
country: Thailand
facility: Chiangrai Prachanukroh Hospital
city: Songkhla
country: Thailand
facility: Prince of Songkla Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Guys Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Torquay
country: United Kingdom
facility: Torbay Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: