Clinical trial NCT02952586: Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)
Official title: A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF AVELUMAB IN COMBINATION WITH STANDARD OF CARE CHEMORADIOTHERAPY (CISPLATIN PLUS DEFINITIVE RADIATION THERAPY) VERSUS STANDARD OF CARE CHEMORADIOTHERAPY IN THE FRONT-LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of the Head and Neck
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 697
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.


Eligibility criteria: INCLUSION CRITERIA

* Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
* HPV negative disease, Stage III, IVa, IVb; non-oropharyngeal HPV positive disease Stage III, IVa, IVb, HPV positive oropharyngeal disease T4 or N2c or N3
* No prior therapy for advanced stage SCCHN; eligible for definitive CRT with curative intent.
* Available tumor samples for submission or willing to undergo further tumor biopsies:
* Age ≥18 years (≥19 in Korea;20 years in Japan and Taiwan).
* ECOG Performance Status 0 or 1
* Adequate bone marrow function
* Adequate renal function
* Adequate liver function
* Pregnancy test (for patients of childbearing potential) negative at screening

EXCLUSION CRITERIA

* Prior immunotherapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways.
* Major surgery 4 weeks prior to randomization.
* Prior malignancy requiring tumor-directed therapy within the last 2 years prior to enrollment, or concurrent malignancy associated with clinical instability. Exceptions for disease within the 2 years are superficial esophageal cancer (TIS or T1a) fully resected by endoscopy, prostate cancer (Gleason score 6) either curatively treated or deemed to not require treatment, ductal IS carcinoma of the breast that has completed curative treatment, adequately treated basal cell or squamous cell skin cancer.
* Active autoimmune disease
* Any of the following in the 6 months prior to randomization: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism.
* Active infection requiring systemic therapy.
* Use of immunosuppressive medication at time of randomization
* Prior organ transplantation including allogenic stem-cell transplantation.
* Diagnosis of prior immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
* Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Vaccination within 4 weeks prior to randomization.
* Current use of or anticipated need for treatment with other anti-cancer drugs.
* Pregnant female patients, breastfeeding female patients, and male patients able to father children and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study and for at least 6 months after the last dose of cisplatin and 60 days after the last dose of avelumab/placebo (whichever is later).

Primary outcomes:
measure: Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator
timeFrame: From randomization until documented PD or death, censored date, whichever occurred first (up to 37 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization to the date of death or censored date, whichever occurred first (up to 37 months)
measure: Pathologic Complete Response (pCR) Rate in Participants With Salvage Surgery at the Primary Site
timeFrame: From randomization until PD or death (up to 37 months)
measure: Time to Locoregional Failure Per Modified RECIST v1.1 as Assessed by Investigator
timeFrame: From the date of randomization to the date of the first documentation of locoregional recurrence or death, whichever occurred first (up to 37 months)
measure: Objective Response Rate (ORR) Per Modified RECIST v1.1 as Assessed by Investigator
timeFrame: From randomization until disease progression or death, whichever occurred first (up to 37 months)
measure: Time to Distant Metastatic Failure Per Modified RECIST v1.1 as Assessed by Investigator
timeFrame: From the date of randomization to the date of the first documentation of distant metastatic or death (up to 37 months)
measure: Duration of Response (DOR) Per Modified RECIST v1.1 as Assessed by Investigator
timeFrame: From the first documentation of objective tumor response to the first documentation of PD or death or censored date, whichever occurred first (up to 37 months)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
timeFrame: Baseline up to 44 months
measure: Number of Participants With Shift From Baseline in Clinical Laboratory Parameters
timeFrame: Baseline up to 15 months
measure: Change From Baseline in Vital Sign - Systolic and Diastolic Blood Pressure
timeFrame: Baseline, Lead-in phase: Day1; CRT Phase: Days 1, 8, 22, 25, 39, and 43; Maintenance phase: on Days 1 and 15 in Cycles 1 to 13 and EOT (3 days after the last dose of study drug)
measure: Change From Baseline in Vital Sign - Pulse Rate
timeFrame: Baseline, Lead-in phase: Day1; CRT Phase: Days 1, 8, 22, 25, 39, and 43; Maintenance phase: on Days 1 and 15 in Cycles 1 to 13 and EOT (3 days after the last dose of study drug)
measure: Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Index Score at CRT Phase and Maintenance Phase
timeFrame: Baseline, CRT Phase: Days 1 and 29; Maintenance phase: Cycle 1/Day 1, Cycle 3/Day 1, Cycle 7/Day 1, Cycle 7/Day 15, Cycle 11/Day 1, Cycle 11/Day 15, EOT (3 days after the last dose of study drug)
measure: Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) VAS Score at CRT Phase and Maintenance Phase
timeFrame: Baseline, CRT Phase: Days 1 and 29; Maintenance phase: Cycle 1/Day 1, Cycle 3/Day 1, Cycle 7/Day 1, Cycle 7/Day 15, Cycle 11/Day 1, Cycle 11/Day 15, EOT (3 days after the last dose of study drug)
measure: Change From Baseline in National Cancer Comprehensive Network Head and Neck Symptom Index-22 Item Scores (NCCN FHNSI-22) at CRT Phase and Maintenance Phase
timeFrame: Baseline, CRT Phase: Days 1 and 29; Maintenance phase: Cycle 1/Day 1, Cycle 3/Day 1, Cycle 7/Day 1, Cycle 7/Day 15, Cycle 11/Day 1, Cycle 11/Day 15, EOT (3 days after the last dose of study drug)
measure: Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
timeFrame: Baseline (prior to first dose)
measure: Mean Percentage (%) of Total Tumor Area Occupied by Cluster of Differentiation 8 (CD8+) Cells
timeFrame: Baseline (prior to first dose)
measure: Percentage of Participants With Positive and Negative Pathology of Neck Dissection
timeFrame: From randomization until PD as per investigator assessment (up to 37 months)
measure: Maximum Plasma Concentration (Cmax) of Avelumab
timeFrame: Pre-dose and end of infusion on Day 1 of lead-in phase, Days 8, 25 of CRT phase, Day 1 of Cycle 1 and 2 (each cycle 28 days)
measure: Predose Plasma Concentration (Ctrough) of Avelumab
timeFrame: Pre-dose on Day 1 of lead-in phase, Days 8, 25 of CRT phase, Day 1 of Cycle 1, 2, 5, 8, 11 (each cycle 28 days)
measure: Dose Normalized Maximum Plasma Concentration (Cmax [dn]) of Total and Free Cisplastin
timeFrame: Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
measure: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of Total and Free Cisplatin
timeFrame: Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
measure: Maximum Plasma Concentration (Cmax) of Total and Free Cisplatin
timeFrame: Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
measure: Time to Attain Maximum Observed Plasma Concentration (Tmax) of Total and Free Cisplatin
timeFrame: Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
measure: Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status
timeFrame: pre-dose on Day 1 up to 30 Days after the end of treatment
measure: Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status
timeFrame: Day 1 of lead-in phase and on Days 8 and 25 of CRT phase
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Anaheim
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
state: California
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Beverly Hills
country: United States
facility: Tower Hematology Oncology Medical Group
state: California
city: Chula Vista
country: United States
facility: UCSD Radiation Oncology South Bay, Cancer Treatment Centers
state: California
city: Corona
country: United States
facility: City of Hope Corona
state: California
city: Corona
country: United States
facility: Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
state: California
city: Downey
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Duarte
country: United States
facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
state: California
city: Glendale
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: La Jolla
country: United States
facility: UC San Diego Medical Center- La Jolla (Thornton Hospital)
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Lancaster
country: United States
facility: City of Hope Antelope Valley
state: California
city: Long Beach
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Los Angeles
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
state: California
city: Lynwood
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Montebello
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Riverside
country: United States
facility: Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: UC San Diego Medical Center- Hillcrest
state: California
city: Santa Ana
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: South Pasadena
country: United States
facility: City of Hope South Pasadena
state: California
city: Torrance
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: West Covina
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Whittier
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Aurora
country: United States
facility: Rocky Mountain Lions Eye Institute
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Denver CTO/CTRC
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Inpatient Pavilion
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Outpatient Pavilion
state: Colorado
city: Aurora
country: United States
facility: University Of Colorado Hospital Cancer Center
state: Colorado
city: Denver
country: United States
facility: Cypress Hematology & Oncology
state: Colorado
city: Parker
country: United States
facility: Cypress Hematology and Oncology
state: Colorado
city: Coral Gables
country: United States
facility: Sylvester at Coral Gables
state: Florida
city: Deerfield Beach
country: United States
facility: Sylvester at Deerfield Beach
state: Florida
city: Hialeah
country: United States
facility: Specialist Global LLC
state: Florida
city: Hollywood
country: United States
facility: Memorial Cancer Institute at Memorial Regional Hospital
state: Florida
city: Lakeland
country: United States
facility: Hollis Cancer Center
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Cancer Institute at Memorial Hospital West
state: Florida
city: Plantation
country: United States
facility: Sylvester at Plantation
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Flossmoor
country: United States
facility: Primary Healthcare Associates
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Harvey
country: United States
facility: Primary Healthcare Associates
state: Illinois
city: Tinley Park
country: United States
facility: Primary Healthcare Associates
state: Illinois
city: Lafayette
country: United States
facility: IU Health Arnett Cancer Center
state: Indiana
city: Overland Park
country: United States
facility: Kansas City VA Radiation Oncology Clinic
state: Kansas
city: Ashland
country: United States
facility: Ashland-Bellefonte Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: Louisville
country: United States
facility: University Medical Center, Inc.
state: Kentucky
city: Louisville
country: United States
facility: Norton Brownsboro Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Prestonsburg
country: United States
facility: Highlands Cancer Center
state: Kentucky
city: Baltimore
country: United States
facility: Maryland Proton Treatment Center
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland, Greenebaum Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Farmington Hills
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Lansing
country: United States
facility: Herbert-Herman Cancer Center, Sparrow Hospital
state: Michigan
city: Columbia
country: United States
facility: University of Missouri- Ellis Fischel Cancer Center
state: Missouri
city: Creve Coeur
country: United States
facility: Siteman Cancer Center - West County
state: Missouri
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
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 Siteman Cancer Center
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: Department of Radiation Oncology Methodist Hospital
state: Nebraska
city: Omaha
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: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
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: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
city: Bronx
country: United States
facility: Montefiore-Einstein Center for Cancer Care
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
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: Bellevue Hospital Center
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Radiology
state: New York
city: New York
country: United States
facility: NYU Langone Radiology - Ambulatory Care Center East 41st Street
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: Breast and Imaging Center
state: New York
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
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Cancer Center- Nassau
state: New York
city: Charlotte
country: United States
facility: Oncology Specialists of Charlotte, PA
state: North Carolina
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: OU Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center- Stephenson Cancer Center
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Health Network Cancer Center Pharmacy
state: Pennsylvania
city: Allentown
country: United States
facility: Lehigh Valley Health Network-Cedar Crest
state: Pennsylvania
city: Allentown
country: United States
facility: Radiation Oncology Cancer Services
state: Pennsylvania
city: Bethlehem
country: United States
facility: Lehigh Valley Health Network-Muhlenberg
state: Pennsylvania
city: Gettysburg
country: United States
facility: Precision Cancer Research / Gettysburg Cancer Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: PinnacleHealth Cancer Institute
state: Pennsylvania
city: Mechancisburg
country: United States
facility: PinnacleHealth Cancer Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside Radiation Oncology
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC- Rutledge Tower
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina- Hollings Cancer Center
state: South Carolina
city: Charleston
country: United States
facility: MUSC SCTR Research Nexus Clinical Science Building
state: South Carolina
city: Charleston
country: United States
facility: MUSC- Ashley River Tower
state: South Carolina
city: Charleston
country: United States
facility: MUSC- Radiation Oncology
state: South Carolina
city: Charleston
country: United States
facility: MUSC- University Hospital
state: South Carolina
city: Easley
country: United States
facility: GHS Cancer Institute
state: South Carolina
city: Greenville
country: United States
facility: GHS Cancer Institute
state: South Carolina
city: Greenville
country: United States
facility: GHS Cancer Institute
state: South Carolina
city: Greer
country: United States
facility: GHS Cancer Institute
state: South Carolina
city: Seneca
country: United States
facility: GHS Cancer Institute
state: South Carolina
city: Spartanburg
country: United States
facility: GHS Cancer Institute
state: South Carolina
city: Germantown
country: United States
facility: The West Clinic, PC dba West Cancer Center
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic PC dba West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Henry-Joyce Cancer Clinic
state: Tennessee
city: El Paso
country: United States
facility: Texas Oncology El Paso Cancer Treatment Center
state: Texas
city: El Paso
country: United States
facility: William Beaumont Army Medical Center
state: Texas
city: El Paso
country: United States
facility: William Beaumont Army Medical Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital - TMC
state: Texas
city: Houston
country: United States
facility: UTHealth/Memorial Hermann Cancer Center
state: Texas
city: League City
country: United States
facility: UTMB Cancer Center at Victory Lakes
state: Texas
city: Murray
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse Medical Imaging
state: New South Wales
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse Radiation Oncology Department
state: New South Wales
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: St Leonards
country: Australia
facility: Northern Sydney Cancer Centre
state: New South Wales
city: Wollongong
country: Australia
facility: Illawarra Shoalhaven Local Health District
state: New South Wales
city: Geelong
country: Australia
facility: Barwon Health, University Hospital Geelong
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH
city: Brussels
country: Belgium
facility: University Hospital Brussels
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi - Site Notre-Dame
city: Haine Saint Paul
country: Belgium
facility: Centre Hospitalier de Jolimont
city: Namur
country: Belgium
facility: Site Sainte Elisabeth / CHU UCL Namur
city: Wilrijk
country: Belgium
facility: GZA Hospitals Campus Sint Augustinus
city: Quebec
country: Canada
facility: CHU de Quebec - Universite Laval
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: SUN Yat-Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Cancer Center of Guangzhou Medical University/Oncology Department
state: Guangdong
city: Nanning
country: China
facility: Affiliated Tumor Hospital of Guangxi Medical University
state: Guangxi
city: Haikou
country: China
facility: Hai Nan General Hospital
state: Hainan
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
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, Huazhong University of Science & Technology/Cancer Center
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University/Oncology Department
state: Hunan
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital/Oncology Department
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
city: Angers cedex 02
country: France
facility: Institut de Cancerologie de l'Ouest (ICO) - Site Paul Papin
city: Avignon cedex 9
country: France
facility: Institut Sainte Catherine
city: Bordeaux
country: France
facility: Hopital Pellegrin - Service de radiologie et d'imagerie
city: Bordeaux
country: France
facility: Hopital Saint-Andre
city: Brest
country: France
facility: Cabinet de radiologie Privé - Dr Joseph Mocaer
city: Brest
country: France
facility: Clinique Pasteur - CFRO
city: Levallois-Perret
country: France
facility: Hopital Franco-Britannique, Institut d'Oncologie Hauts-de-Seine Nord
city: Montpellier cedex 5
country: France
facility: Institut Regional du Cancer Montpellier - Val d'Aurelle
city: Nantes cedex 2
country: France
facility: Hopital prive du Confluent S.A.S.
city: Nantes cedex 2
country: France
facility: Hopital prive du Confluent S.A.S
city: Neuilly sur Seine
country: France
facility: Clinique Hartmann
city: Neuilly Sur Seine
country: France
facility: Hopital Americain de Paris
city: Nice cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
city: Saint Gregoire
country: France
facility: Centre Hospitalier Prive Saint Gregoire
city: Saint Herblain Cedex
country: France
facility: Institut de Cancerologie de l'Ouest (ICO) - Site Rene Gauducheau
city: Saint Priest en Jarez cedex
country: France
facility: Institut de cancerologie de la Loire Lucien Neuwirth
city: Strasbourg Cedex
country: France
facility: Centre Paul Strauss - Radiologie et medecine nucleaire
city: Strasbourg
country: France
facility: ICANS - Institut de cancerologie Strasbourg Europe
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch, Institut fur Rontgendiagnostik
state: Buch
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch, Klinik fur Nuklearmedizin
state: Buch
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch, Klinik fur Strahlentherapie
state: Buch
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
state: Buch
city: Dusseldorf
country: Germany
facility: Universitatsklinikum Dusseldorf
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Athens
country: Greece
facility: General Oncology Hospital of Kifissia "Agioi Anargiroi"
state: Attica
city: Haidari
country: Greece
facility: Attikon University Hospital
state: Attica
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet, B Belgyogyaszati Osztaly
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet, Sugarterapias Osztaly
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Koraz, Onkoradiologiai osztaly
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem, Klinikai Kozpont, Onkoterapias Intezet
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont
city: Dublin
country: Ireland
facility: St Luke's Radiation Oncology Network, St Luke's Hospital
city: Dublin
country: Ireland
facility: St James's Hospital
city: Dublin
country: Ireland
facility: St. James's Hospital
city: Dublin
country: Ireland
facility: Blackrock Clinic
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah University Hospital, Department of Oncology
city: Petah Tiqva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba M.C.Tel-Hashomer
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia
state: BS
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (I.R.S.T)
state: FC
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
state: FC
city: Cesena
country: Italy
facility: Ospedale M. Bufalini
state: Forlì-cesena
city: Meldola
country: Italy
facility: IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
state: Forlì-cesena
city: Lecce
country: Italy
facility: Presidio Ospedaliero Vito Fazzi
state: LE
city: Modena
country: Italy
facility: AOU Policlinico Di Modena
state: MO
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
state: PR
city: Lugo
country: Italy
facility: UOC Oncologia Medica, AUSL della Romagna -RAVENNA
state: RA
city: Ravenna
country: Italy
facility: IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
state: RA
city: Ravenna
country: Italy
facility: UOC Oncologia Medica, AUSL della Romagna - RAVENNA
state: RA
city: Legnago
country: Italy
facility: AULSS 9 - Scaligera Ospedale Mater Salutis
state: VR
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS - Fondazione Pascale
city: Reggio Emilia
country: Italy
facility: AUSL - IRCCS and Reggio Emilia
city: Nagoya
country: Japan
facility: Aichi cancer center central hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Natori
country: Japan
facility: Miyagi Cancer Center
state: Miyagi
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Kita-adachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital, Japanese Foundation for Cancer Research
state: Tokyo
city: Goyang-si
country: Korea, Republic of
facility: Center for Proton Therapy, National Cancer Center
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Center for Specific Organ Cancer, National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Department of Radiation Oncology, CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Seoul
country: Korea, Republic of
facility: Division of Radiation Oncology, Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Division of Radiation Oncology, Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Ulsan
country: Korea, Republic of
facility: Department of Radiation Oncology, Ulsan University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. prof. F. Lukaszczyka
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gliwice
country: Poland
facility: Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie, Klinika Radioterapii i Chemioterapii
city: Olsztyn
country: Poland
facility: SPZOZ Ministerstwa Spraw Wewnetrznych i Administracji z Warminsko-Mazurskim Centrum Onkologii
city: Tomaszow Mazowiecki
country: Poland
facility: NZOZ Provita Prolife Centrum Medyczne
city: Tomaszow Mazowiecki
country: Poland
facility: Specjalistyczny Szpital Onkologiczny NU-MED sp. z o.o.
city: Matosinhos
country: Portugal
facility: Hospital Pedro Hispano
state: Porto
city: Senhora da Hora
country: Portugal
facility: CUF Porto
state: Porto
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
state: Porto
city: Coimbra
country: Portugal
facility: Instituto Portugues de Oncologia de Coimbra Francisco Gentil, E.P.E.
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto, E.P.E.- Hospital de Santo Antonio
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
city: Porto
country: Portugal
facility: Centro Hospitalar São João, E.P.E
city: Porto
country: Portugal
facility: Julio Teixeira
city: Chelyabinsk
country: Russian Federation
facility: SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
city: Moscow
country: Russian Federation
facility: N. N. Blokhin NMRCO
city: Omsk
country: Russian Federation
facility: Budgetary Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary"
city: Saint-Petersburg
country: Russian Federation
facility: FSBI "National Medical Research Center of Oncology n.a. N.N. Petrov"
city: Saint-Petersburg
country: Russian Federation
facility: SBIH "SPb Clinical Research Centre of Specialized Kinds of Medical Care (Oncology)"
city: Yaroslavl
country: Russian Federation
facility: SBHI YaR "Regional Clinical Oncology Hospital"
city: Badalona
country: Spain
facility: Institut Catala d'Oncologia Badalona, Hospital Germans Trias i Pujol
state: Barcelona
city: San Sebastian
country: Spain
facility: Hospital Universitario Donostia
state: Guipuzcoa
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Malaga
city: El Palmar
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca
state: Murcia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Girona
country: Spain
facility: Institut Catala D'Oncologia de Girona
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Valencia
country: Spain
facility: Fundacion Instituto Valenciano de Oncologia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Basel
country: Switzerland
facility: Klinik fur Radiologie und Nuklearmedizin
state: Basel-stadt
city: Basel
country: Switzerland
facility: Klinik fur Strahlentherapie und Radioonkologie
state: Basel-stadt
city: Basel
country: Switzerland
facility: Universitatsspital Basel
state: Basel-stadt
city: Bellinzona
country: Switzerland
facility: Istituto Oncologico della Svizzera Italiana IOSI, Ospedale San Giovanni
state: Ticino
city: Bellinzona
country: Switzerland
facility: Radiologia ORBV, Ospedale San Giovanni
state: Ticino
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur, Medizinische Onkologie
state: Zuerich
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur, Radiologie
state: Zurich
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zurich
city: Zurich
country: Switzerland
facility: Institut fur Klinische Pathologie
city: Zurich
country: Switzerland
facility: Klinik fur Nuklearmedizin
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital-Linkou Branch
city: Aberdeen
country: United Kingdom
facility: NHS Grampian
city: Bebington
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: University Hospital Bristol NHS Foundation Trust
city: Edinburgh
country: United Kingdom
facility: NHS Lothian, Western General Hospital
city: London
country: United Kingdom
facility: Guy's and St. Thomas' NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Lee NY, Ferris RL, Psyrri A, Haddad RI, Tahara M, Bourhis J, Harrington K, Chang PM, Lin JC, Razaq MA, Teixeira MM, Lovey J, Chamois J, Rueda A, Hu C, Dunn LA, Dvorkin MV, De Beukelaer S, Pavlov D, Thurm H, Cohen E. Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):450-462. doi: 10.1016/S1470-2045(20)30737-3.