Clinical trial NCT04607421: A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
Official title: AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST-LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC BRAF V600E-MUTANT COLORECTAL CANCER
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Neoplasms
Keywords: Colorectal cancer
Colon cancer
Rectal cancer
Colorectal Neoplasms
Intestinal cancer
Intestinal Neoplasms
Gastrointestinal cancer
Gastrointestinal Neoplasms
Digestive system cancer
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
BREAKWATER Study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
name: Merck KGaA, Darmstadt, Germany
name: Eli Lilly and Company
First posted: 2020-10-29
Enrollment: 827
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that:

* has spread to other parts of the body (metastatic);
* has a certain type of abnormal gene called "BRAF"; and
* has not received prior treatment.

Participants in this study will receive one of the following study treatments:

* Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic.
* Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home.
* Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home.

This study is currently enrolling participants who will receive either encorafenib plus cetuximab with chemotherapy or chemotherapy alone.

The study team will monitor how each participant responds to the study treatment for up to about 3 years.

Detailed description: The purpose of the study is to evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of-care chemotherapy in participants with previously untreated BRAF V600E-mutant mCRC. Since encorafenib has not previously been combined with chemotherapy, the tolerability and PK of EC in combination with mFOLFOX6 and in combination with FOLFIRI will be evaluated in separate cohorts in the safety lead-in portion of the trial in order to identify which chemotherapy combination is to be used in the Phase 3 portion of the study.

Eligibility criteria: Inclusion Criteria:

* Safety Lead-In = Male/female ≥ 18 years old
* Phase 3 and Cohort 3: Male/female ≥ 16 years old (where permitted locally)
* Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation
* Prior systemic treatment in metastatic setting: 0-1 regimens for Safety Lead In; none for Phase 3 and Cohort 3. (Note: Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis \< 6 month from end of adj/neoadjuvant treatment )
* Measurable disease (Phase 3 and Cohort 3)/ Measurable or evaluable disease (Safety Lead-in)
* ECOG PS 0-1
* Adequate organ function

Exclusion Criteria:

* Tumors that are locally confirmed or unknown MSI-H or dMMR unless participant is ineligible to receive immune checkpoint inhibitors due to a pre-existing medical condition
* Active bacterial or viral infections in 2 weeks prior to starting dosing
* Symptomatic brain metastases

Primary outcomes:
measure: Safety Lead-in Study: Incidence of Dose Limiting Toxicities (DLTs)
timeFrame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
measure: Phase 3: Progression free survival, by blinded independent review
timeFrame: Duration of Phase 3, approximately 36 months
measure: Phase 3: Objective response rate by blinded independent review
timeFrame: Duration of Phase 3, approximately 23 months
measure: Cohort 3: Objective response rate by blinded independent review
timeFrame: Duration of Cohort 3, approximately 15 months.
Secondary outcomes:
measure: Safety Lead-in: Incidence of adverse events
timeFrame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
measure: Safety Lead-in: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
timeFrame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
measure: Safety Lead-in: Incidence of dose interruptions, dose modifications and discontinuations due to adverse events
timeFrame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
measure: Safety Lead-in: Overall response rate by investigator
timeFrame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
measure: Safety Lead-in: Duration of response by Investigator
timeFrame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
measure: Safety Lead-in:Progression free survival by Investigator
timeFrame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
measure: Safety Lead-in: Time to response by Investigator
timeFrame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
measure: Safety Lead-in: Overall survival
timeFrame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 36 months
measure: Phase 3: Overall survival
timeFrame: Duration of Phase 3, approximately 50 months
measure: Phase 3: Overall response rate by Investigator and by blinded independent review
timeFrame: Duration of Phase 3, approximately 36 months
measure: Phase 3: Duration of response by Investigator and blinded independent review
timeFrame: Duration of Phase 3, approximately 36 months
measure: Phase 3: Time to response by blinded independent review and by Investigator
timeFrame: Duration of Phase 3, approximately 36 months
measure: Phase 3: Progression free survival by Investigator and by blinded independent review
timeFrame: Duration of Phase 3, approximately 36 months
measure: Phase 3: Progression free survival 2 by Investigator
timeFrame: Duration of Phase 3, approximately 36 months
measure: Phase 3: Incidence of adverse events
timeFrame: Duration of Phase 3, approximately 36 months
measure: Phase 3: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
timeFrame: Duration of Phase 3, approximately 36 months
measure: Phase 3: Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Duration of Phase 3, approximately 36 months
measure: Phase 3: Change from Baseline in the EuroQol-5D-5L (EQ-5D-5L) Questionnaire
timeFrame: Duration of Phase 3, approximately 36 months
measure: Phase 3: Change from Baseline in the Patient Global Impression of Severity (PGIS)
timeFrame: Duration of Phase 3, approximately 36 months
measure: Phase 3: Change from Baseline in the Patient Global Impression of Change (PGIC) questionnaires
timeFrame: Duration of Phase 3, approximately 36 months
measure: Phase 3: Confirm the MSI-status in tumor tissue
timeFrame: Once, pre-treatment
measure: Phase 3: To determine the correlation between ctDNA levels, BRAF V600 alterations, and clinical outcome
timeFrame: Predose on Cycle 1 Day 1, 15, Cycle 2 Day 15, Cycle 7 Day 1 and EOT. Arm C sampling on Day 1 of Cycles 1-3, 9 and EOT. EOT is approx 36 months.
measure: Safety Lead-in: Maximum plasma concentration of encorafenib, LHY746, irinotecan and SN-38
timeFrame: Cycle 1 Day 1 and Day 15: predose, and 0.75, 1.5, 2.5, 3.5, 5.5 and 7.5 hours after dosing, Cycle 1 Day 3 and Day 17:predose and Cycle 2 through Cycle 6: Day 1 predose. Each cycle is 28 days
measure: Safety Lead-in: Area under the plasma concentration time curve of encorafenib, LHY746, irinotecan and SN-38
timeFrame: Cycle 1 Day 1 and Day 15: predose, and 0.75, 1.5, 2.5, 3.5, 5.5 and 7.5 hours after dosing, Cycle 1 Day 3 and Day 17:predose and Cycle 2 through Cycle 6: Day 1 predose. Each cycle is 28 days.
measure: Safety Lead-in: Time to maximim plasma concentration time curve of encorafenib, LHY746, irinotecan and SN-38
timeFrame: Cycle 1 Day 1 and Day 15: predose, and 0.75, 1.5, 2.5, 3.5, 5.5 and 7.5 hours after dosing, Cycle 1 Day 3 and Day 17:predose and Cycle 2 through Cycle 6: Day 1 predose. Each cycle is 28 days
measure: Safety Lead-in: Maximum plasma concentration of encorafenib, LHY746 and oxaliplatin
timeFrame: Cycle 1 Day 1 and Day 15: predose, and 1, 2, 3, 4, 6 and 8 hours after dosing, Cycle 1 Day 3 and Day 17: predose and Cycle 2 through Cycle 6: Day 1 predose. Each cycle is 28 days
measure: Safety Lead-in: Area under the plasma concentration time curve of encorafenib, LHY746 and oxaliplatin
timeFrame: Cycle 1 Day 1 and Day 15: predose, and 1, 2, 3, 4, 6 and 8 hours after dosing, Cycle 1 Day 3 and Day 17: predose and Cycle 2 through Cycle 6: Day 1 predose. Each cycle is 28 days
measure: Safety Lead-in: Clearance of irinotecan, SN-38 and oxaliplatin
timeFrame: Cycle 1 Day 1 and Day 15: predose, and 0.75, 1.5, 2.5, 3.5, 5.5 and 7.5 hours after dosing, Cycle 1 Day 3 and Day 17:predose and Cycle 2 through Cycle 6: Day 1 predose. Each cycle is 28 days
measure: Safety Lead-in: Time to maximim plasma concentration time curve of encorafenib, LHY746 and oxaliplatin
timeFrame: Cycle 1 Day 1 and Day 15: predose, and 1, 2, 3, 4, 6 and 8 hours after dosing, Cycle 1 Day 3 and Day 17: predose and Cycle 2 through Cycle 6: Day 1 predose. Each cycle is 28 days
measure: Phase 3: Trough concentrations of encorafenib and its metabolite LHY746
timeFrame: Predose on Cycle 1 through Cycle 6. Each cycle is 28 days
measure: Cohort 3: Progression free survival by Investigator and by blinded independent review
timeFrame: Duration of Cohort 3, approximately 21 months
measure: Cohort 3: Overall response rate by investigator
timeFrame: Duration of Cohort 3, approximately 21 months
measure: Cohort 3: Duration of response by Investigator and by blinded independent review
timeFrame: Duration of Cohort 3, approximately 21 months
measure: Cohort 3: Time to response by Investigator and by blinded independent review
timeFrame: Duration of Cohort 3, approximately 21 months
measure: Cohort 3: Overall survival
timeFrame: Duration of Cohort 3, approximately 36 months
measure: Cohort 3: Incidence of adverse events
timeFrame: Duration of Cohort 3, approximately 21 months
measure: Cohort 3: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
timeFrame: Duration of Cohort 3, approximately 21 months
measure: Cohort 3: Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Duration of Cohort 3, approximately 21 months
measure: Cohort 3: Change from Baseline in the EuroQol-5D-5L (EQ-5D-5L) Questionnaire
timeFrame: Duration of Cohort 3, approximately 21 months
measure: Cohort 3: Change from Baseline in the Patient Global Impression of Severity (PGIS)
timeFrame: Duration of Cohort 3, approximately 21 months
measure: Cohort 3: Change from Baseline in the Patient Global Impression of Change (PGIC) questionnaires
timeFrame: Duration of Cohort 3, approximately 21 months
measure: Cohort 3: Confirm the MSI-status in tumor tissue
timeFrame: Once, pre-treatment
measure: Cohort 3: To determine the correlation between ctDNA levels, BRAF V600 alterations, and clinical outcome
timeFrame: Predose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 15, Cycle 7 Day 1 and End of Treatment (Duration of Cohort 3, approximately 21 months). Each cycle is 28 days.
measure: Cohort 3: Trough concentrations of encorafenib and its metabolite LHY746
timeFrame: Predose on Cycle 1 through Cycle 6. Each cycle is 28 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona - Scottsdale
state: Arizona
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: LAC & USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Pasadena
country: United States
facility: Keck Hospital of USC Pasadena
state: California
city: Aventura
country: United States
facility: Mount Sinai Comprehensive Cancer Center, Aventura
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Plantation
country: United States
facility: BRCR Global
state: Florida
city: Plantation
country: United States
facility: BRCR Medical Center Inc.
state: Florida
city: Chicago
country: United States
facility: UChicago Medicine - River East
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Flossmoor
country: United States
facility: UChicago Medicine at Ingalls - Flossmoor
state: Illinois
city: Harvey
country: United States
facility: UChicago Medicine Ingalls Memorial
state: Illinois
city: New Lenox
country: United States
facility: University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
state: Illinois
city: Orland Park
country: United States
facility: The University of Chicago Medicine Center for Advanced Care Orland Park
state: Illinois
city: Tinley Park
country: United States
facility: UChicago Medicine at Ingalls - Tinley Park
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation Research Pharmacy
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Creve Coeur
country: United States
facility: Siteman Cancer Center - West County
state: Missouri
city: Florissant
country: United States
facility: Siteman Cancer Center - North County
state: Missouri
city: Saint Louis
country: United States
facility: Barnes- Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Siteman Cancer Center - South County
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center - St Peters
state: Missouri
city: Omaha
country: United States
facility: Oncology Hematology West PC dba Nebraska Cancer Specialists
state: Nebraska
city: Omaha
country: United States
facility: Oncology Hematology West PC dba Nebraska Cancer Specialists
state: Nebraska
city: Omaha
country: United States
facility: Oncology Hematology West PC dba Nebraska Cancer Specialists
state: Nebraska
city: Omaha
country: United States
facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists - IP Storage
state: Nebraska
city: Papillion
country: United States
facility: Oncology Hematology West PC dba Nebraska Cancer Specialists
state: Nebraska
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center - Basking Ridge
state: New Jersey
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Cancer Center- Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Cancer Center- Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center - Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center - Main Campus
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Cancer Center- Nassau
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University James Cancer Hospital and Solove Research Institute
state: Ohio
city: Columbus
country: United States
facility: Stefanie Spielman Comprehensive Breast Cancer
state: Ohio
city: Columbus
country: United States
facility: Martha Morehouse Medical Plaza
state: Ohio
city: Columbus
country: United States
facility: The James Outpatient Care West Campus
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center, OU Health Stephenson Cancer Center
state: Oklahoma
city: Portland
country: United States
facility: Providence Cancer Institute Franz Clinic
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Onc and Heme Care Clinic - Westside
state: Oregon
city: Portland
country: United States
facility: Providence St Vincent Medical Center
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center Investigational Drug Service
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Germantown
country: United States
facility: The West Clinic. PLLC. dba West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Henry-Joyce Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Oncology IDS Pharmacy
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Richmond
country: United States
facility: VCU Health - Adult Outpatient Pavilion (AOP) Investigational Drug Services
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Clinical Science Center
state: Wisconsin
city: San Miguel De Tucumán
country: Argentina
facility: Centro Medico San Roque
state: Tucumán
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Médico Especializado Alexander Fleming
city: Cordoba
country: Argentina
facility: Clinica Universitaria Reina Fabiola
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Médico de Córdoba
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: GenesisCare - North Shore
state: New South Wales
city: St Leonards
country: Australia
facility: GenesisCare North Shore
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Brussels
country: Belgium
facility: Université Libre de Bruxelles - Hôpital Erasme
state: Bruxelles-capitale, Région DE
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Bruxelles-capitale, Région DE
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
state: Hainaut
city: Kortrijk
country: Belgium
facility: AZ Groeninge Campus Kennedylaan
state: West-vlaanderen
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
city: Wilrijk
country: Belgium
facility: GZA Hospitals Campus Sint Augustinus
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RIO Grande DO SUL
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
state: RJ
city: Blumenau
country: Brazil
facility: Reichow - Centro de Ensino e Pesquisa
state: Santa Catarina
city: Itajaí
country: Brazil
facility: Clínica de Neoplasias Litoral
state: Santa Catarina
city: Santo Andre
country: Brazil
facility: FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Onco
state: SP
city: Santo André
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
state: SP
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
state: SÃO Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: SÃO Paulo
city: Panagyurishte
country: Bulgaria
facility: MHAT Uni Hospital OOD
state: Pazardzhik
city: Gabrovo
country: Bulgaria
facility: MHAT "Dr. Tota Venkova" AD
city: Plovdiv
country: Bulgaria
facility: MHAT Central Onco Hospital OOD
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center - Plovdiv EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Nadezhda Clinical EOOD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic MHAT Tokuda
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sofiamed
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: London
country: Canada
facility: London Regional Cancer Program, London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Nanning
country: China
facility: Affiliated Tumor Hospital of Guangxi Medical University
state: Guangxi
city: Nanning
country: China
facility: Affiliated Tumor Hospital of Guangxi Medical University
state: Guangxi
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong province cancer hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Province Cancer Hospital
state: Sichuan
city: Kunming
country: China
facility: Yunnan Cancer Hospital(The Third Affiliated Hospital of Kunming Medical University)
state: Yunnan
city: Hangzhou
country: China
facility: The second Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Peking University First Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin
country: China
facility: Tianjin Union Medical Center
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno Bohunice
state: Brno-město
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
state: Hradec Králové
city: Prague
country: Czechia
facility: Fakultni Thomayerova nemocnice
state: Praha 4
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 8
country: Czechia
facility: Fakultni nemocnice Bulovka
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Syd
state: Nordjylland
city: Vejle
country: Denmark
facility: Vejle Hospital-Sygehus Lillebaelt
state: Syddanmark
city: Vejle
country: Denmark
facility: Vejle Sygehus
state: Syddanmark
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Helsinki
country: Finland
facility: Docrates Syöpäsairaala
state: Nyland
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Pori
country: Finland
facility: Satakunnan Keskussairaala
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
city: Turku
country: Finland
facility: Turku University Hospital
city: Muenchen
country: Germany
facility: Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
state: Bayern
city: Frankfurt
country: Germany
facility: Institut für Klinisch Onkologische Forschung
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Lower Saxony
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Berlin - Charlottenburg
country: Germany
facility: Radiologie Berlin
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfuerstendamm
city: Berlin
country: Germany
facility: Waage Apotheke
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin Buch GmbH
city: Dresden
country: Germany
facility: Technische Universität Dresden, Medizinische Fakultät Carl Gustav Carus
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf
city: Hamburg
country: Germany
facility: ZytoService Deutschland GmbH, Standort-Hamburg-Jenfeld
city: Hamburg
country: Germany
facility: Radiologie im Israelitischen Krankenhaus
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute And Research Centre
state: Delhi
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Centre
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Speciality Hospital
state: Maharashtra
city: Thane
country: India
facility: Bhakti Vedanta Hospital and Research Institute
state: Maharashtra
city: Jaipur
country: India
facility: R K Birla Cancer Center, SMS Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Sawai Man Singh Medical College Hospital (SMS Hospital)
state: Rajasthan
city: Monserrato (CA)
country: Italy
facility: Azienda Ospedaliera Universitaria di Cagliari - Presidio Policlinico Universitario "D.Casula"
state: Cagliari
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza
state: Foggia
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: Milano
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo IRCCS
state: Torino
city: Orbassano
country: Italy
facility: Azienda Ospedaliero Universitaria San Luigi Gonzaga
state: Torino
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" di Napoli
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto (IOV)
city: Reggio Emilia
country: Italy
facility: Azienda USL - IRCCS di Reggio Emilia - Arcispedale Santa Maria Nuova
city: Chiba-shi
country: Japan
facility: Chiba cancer center
state: Chiba
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa cancer center
state: Kanagawa
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Nagoya, Aichi
city: Osaka-shi
country: Japan
facility: Osaka Prefectural Hospital Organization Osaka International Cancer Institute
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Osaka
city: Hidaka-city
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Ina-machi
country: Japan
facility: Saitama Prefectural Cancer Center
state: Saitama
city: Nagaizumi
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: Japanese Foundation for Cancer Research
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Osaka
country: Japan
facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
city: Tokyo
country: Japan
facility: Keio university hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Taegu-kwangyǒkshi
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
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: 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: Monterrey
country: Mexico
facility: Accelerium, S. de R.L. de C.V.
state: Nuevo LEON
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-brabant
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
state: Noord-holland
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Trondheim
country: Norway
facility: St. Olavs hospital
state: Sør-trøndelag
city: Kristiansand
country: Norway
facility: Sørlandet Sykehus Kristiansand
state: Vest-agder
city: Oslo
country: Norway
facility: Oslo universitetssykehus, Radiumhospitalet
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Ullevål
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED
state: Wielkopolskie
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
city: Bytom
country: Poland
facility: Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu Oddzial Onkologii
city: Gdansk
country: Poland
facility: COPERNICUS PL sp. z. o. o. Wojewodzkie Centrum Onkologii w Gdansku Ambulatoryjna
city: Gdansk
country: Poland
facility: COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
city: Pushkin
country: Russian Federation
facility: Private Medical Institution "Euromedservice"
state: Saint-petersburg
city: Chelyabinsk
country: Russian Federation
facility: GBUZ
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Clinical Oncology Center
city: Moscow
country: Russian Federation
facility: FSAEI HE I.M Sechenov First MSMU MoH Russia (Sechenovskiy University),
city: Omsk
country: Russian Federation
facility: BHI of Omsk Region "Clinical Oncology Dispensary"
city: Omsk
country: Russian Federation
facility: BHI of Omsk Region "Clinical Oncology Dispensary"
city: Saint Petersburg
country: Russian Federation
facility: LLC "EuroCityClinic"
city: Saint-Petersburg
country: Russian Federation
facility: LLC "Medicina Severnoy Stolitsy"
city: Saint-Petersburg
country: Russian Federation
facility: LLC "Severo-Zapadny Medical Center"
city: Saint-Petersburg
country: Russian Federation
facility: Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg
city: St. Petersburg
country: Russian Federation
facility: FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov
city: Yaroslavl
country: Russian Federation
facility: SHI YR Regional Clinical Oncology Hospital
city: Bratislava
country: Slovakia
facility: Narodny Onkologicky Ustav
city: Kosice
country: Slovakia
facility: Vychodoslovensky onkologicky ustav, a.s.
city: Rondebosch
country: South Africa
facility: Cancercare Rondebosch Oncology
state: Cape Town
city: Port Elizabeth
country: South Africa
facility: Cancercare Langenhoven Drive Oncology Centre
state: Eastern CAPE
city: Johannesburg
country: South Africa
facility: Wits Health Consortium (Pty) Ltd
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario Santiago de Compostela
state: A Coruña
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Hospitalet de Llobregat
country: Spain
facility: ICO L'Hospitalet (Hospital Duran i Reynals)
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de octubre
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
state: Stockholms LÄN [se-01]
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
state: Uppsala LÄN [se-03]
city: Umeå
country: Sweden
facility: Norrlands universitetssjukhus
state: Västerbottens LÄN [se-24]
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
state: Västra Götalands LÄN [se14]
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: Tainan
country: Taiwan
facility: Chi Mei Hospital, Liouying
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
city: Dnipro
country: Ukraine
facility: Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk National Medical University
city: Ivano-Frankivsk
country: Ukraine
facility: MNPE "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Regional Council"
city: Kryvyi Rih
country: Ukraine
facility: Communal enterprise "Kryvyi Rih Oncology Dispensary" of Dnipropetrovsk Regional Council
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
state: HIGH Heaton
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital, Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital - Oncology
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: