Study Stopped
The trial prematurely terminated as recommended by the E-DMC because the boundary for futility has been crossed.
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)
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
3 other identifiers
interventional
697
21 countries
315
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2016
Typical duration for phase_3
315 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2016
CompletedFirst Posted
Study publicly available on registry
November 2, 2016
CompletedStudy Start
First participant enrolled
November 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2020
CompletedResults Posted
Study results publicly available
February 24, 2021
CompletedSeptember 22, 2021
September 1, 2021
3.1 years
October 31, 2016
December 21, 2020
September 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator
PFS was defined as the time (in months) from the date of randomization to the first documentation of objective progressive disease (PD) per modified RECIST v1.1 as assessed by Investigator or death (due to any cause), whichever occurred first. Analysis was performed using Kaplan Meier method. PD refers to any of following: 1) Locoregional PD confirmed by pathology to verify radiographic changes represent true tumor progression and not radiation effects or non-malignant contrast enhancement. 2) Locoregional clinically detectable progression confirmed by pathology. 3) Surgical removal (salvage) of primary tumor with tumor present on final pathology. 4) Salvage neck dissection greater than (\>) 20 weeks after completion of CRT with tumor present on final pathology. 5) Metastatic PD. PFS data was censored on date of last adequate tumor assessment for participants with no PFS event.
From randomization until documented PD or death, censored date, whichever occurred first (up to 37 months)
Secondary Outcomes (24)
Overall Survival (OS)
From randomization to the date of death or censored date, whichever occurred first (up to 37 months)
Pathologic Complete Response (pCR) Rate in Participants With Salvage Surgery at the Primary Site
From randomization until PD or death (up to 37 months)
Time to Locoregional Failure Per Modified RECIST v1.1 as Assessed by Investigator
From the date of randomization to the date of the first documentation of locoregional recurrence or death, whichever occurred first (up to 37 months)
Objective Response Rate (ORR) Per Modified RECIST v1.1 as Assessed by Investigator
From randomization until disease progression or death, whichever occurred first (up to 37 months)
Time to Distant Metastatic Failure Per Modified RECIST v1.1 as Assessed by Investigator
From the date of randomization to the date of the first documentation of distant metastatic or death (up to 37 months)
- +19 more secondary outcomes
Study Arms (2)
Avelumab + SOC Chemoradiation Therapy
EXPERIMENTAL* Avelumab 10 mg/kg IV: Day 1 of the Lead-in Phase; Days 8, 25, and 39 of the CRT Phase; and Q2W for 12 months during the Maintenance Phase * Cisplatin 100 mg/m2 IV: Days 1, 22, and 43 of the CRT Phase * Intensity Modulated Radiation Therapy (IMRT) 70 Gy/35 fractions/7 weeks; 1 fraction per day, 5 fractions/week for 7 weeks during the CRT Phase
Placebo + SOC CRT
PLACEBO COMPARATOR* Placebo IV matching avelumab: Days 1 of the Lead-in Phase; Days 8, 25, and 39 of the CRT Phase; Q2W for 12 months during the Maintenance Phase * Cisplatin 100 mg/m2 IV: Days 1, 22, and 43 of the CRT Phase * IMRT 70 Gy/35 fractions/7 weeks; 1 fraction per day, 5 fractions/week for 7 weeks during the CRT Phase
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (316)
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group
Rogers, Arkansas, 72758, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
The Oncology Institute of Hope and Innovation
Anaheim, California, 92801, United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211, United States
UCSD Radiation Oncology South Bay, Cancer Treatment Centers
Chula Vista, California, 91914, United States
City of Hope Corona
Corona, California, 92879, United States
Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
Corona, California, 92879, United States
The Oncology Institute of Hope and Innovation
Downey, California, 90241, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010, United States
The Oncology Institute of Hope and Innovation
Glendale, California, 91204, United States
UC San Diego Medical Center- La Jolla (Thornton Hospital)
La Jolla, California, 92037, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
City of Hope Antelope Valley
Lancaster, California, 93534, United States
The Oncology Institute of Hope and Innovation
Long Beach, California, 90805, United States
The Oncology Institute of Hope and Innovation
Los Angeles, California, 90033, United States
Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048, United States
The Oncology Institute of Hope and Innovation
Lynwood, California, 90262, United States
The Oncology Institute of Hope and Innovation
Montebello, California, 90640, United States
UC Irvine Medical Center
Orange, California, 92868-3201, United States
Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
Riverside, California, 92501, United States
UC San Diego Medical Center- Hillcrest
San Diego, California, 92103, United States
The Oncology Institute of Hope and Innovation
Santa Ana, California, 92705, United States
City of Hope South Pasadena
South Pasadena, California, 91030, United States
The Oncology Institute of Hope and Innovation
Torrance, California, 90503, United States
The Oncology Institute of Hope and Innovation
West Covina, California, 91790, United States
The Oncology Institute of Hope and Innovation
Whittier, California, 90602, United States
Rocky Mountain Lions Eye Institute
Aurora, Colorado, 80045, United States
University of Colorado Denver CTO/CTRC
Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion
Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion
Aurora, Colorado, 80045, United States
University Of Colorado Hospital Cancer Center
Aurora, Colorado, 80045, United States
Cypress Hematology & Oncology
Denver, Colorado, 80210, United States
Cypress Hematology and Oncology
Parker, Colorado, 80138, United States
Sylvester at Coral Gables
Coral Gables, Florida, 33146, United States
Sylvester at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
Specialist Global LLC
Hialeah, Florida, 33012, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Hollis Cancer Center
Lakeland, Florida, 33805, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines, Florida, 33028, United States
Sylvester at Plantation
Plantation, Florida, 33324, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Primary Healthcare Associates
Flossmoor, Illinois, 60422, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Primary Healthcare Associates
Harvey, Illinois, 60426, United States
Primary Healthcare Associates
Tinley Park, Illinois, 60477, United States
IU Health Arnett Cancer Center
Lafayette, Indiana, 47904, United States
Kansas City VA Radiation Oncology Clinic
Overland Park, Kansas, 66212, United States
Ashland-Bellefonte Cancer Center
Ashland, Kentucky, 41101, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Norton Hospital
Louisville, Kentucky, 40202, United States
University Medical Center, Inc.
Louisville, Kentucky, 40202, United States
Norton Brownsboro Hospital
Louisville, Kentucky, 40241, United States
Norton Cancer Institute
Louisville, Kentucky, 40241, United States
Highlands Cancer Center
Prestonsburg, Kentucky, 41653, United States
Maryland Proton Treatment Center
Baltimore, Maryland, 21201, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Karmanos Cancer Institute
Farmington Hills, Michigan, 48334, United States
Herbert-Herman Cancer Center, Sparrow Hospital
Lansing, Michigan, 48912, United States
Siteman Cancer Center- St. Peters
City of Saint Peters, Missouri, 63376, United States
University of Missouri- Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, 63110, United States
Siteman Cancer Center - South County
St Louis, Missouri, 63129, United States
Department of Radiation Oncology Methodist Hospital
Omaha, Nebraska, 68114, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68114, United States
Memorial Sloan Kettering Cancer Center-Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center- Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center- Bergen
Montvale, New Jersey, 07645, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131, United States
Memorial Sloan Kettering Cancer Center Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center Westchester
Harrison, New York, 10604, United States
Bellevue Hospital Center
New York, New York, 10016, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
NYU Langone Medical Center
New York, New York, 10016, United States
NYU Langone Radiology
New York, New York, 10016, United States
NYU Langone Radiology - Ambulatory Care Center East 41st Street
New York, New York, 10017, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10022, United States
Memorial Sloan Kettering Cancer Center: Breast and Imaging Center
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Stony Brook University
Stony Brook, New York, 11794-7007, United States
Stony Brook Cancer Center
Stony Brook, New York, 11794, United States
Montefiore-Einstein Center for Cancer Care
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Memorial Sloan Kettering Cancer Center- Nassau
Uniondale, New York, 11553, United States
Oncology Specialists of Charlotte, PA
Charlotte, North Carolina, 28204, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28210, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
OU Medical Center
Oklahoma City, Oklahoma, 73104, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
University of Oklahoma Health Sciences Center- Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Lehigh Valley Health Network Cancer Center Pharmacy
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Health Network-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Radiation Oncology Cancer Services
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Health Network-Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Precision Cancer Research / Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
PinnacleHealth Cancer Institute
Harrisburg, Pennsylvania, 17109, United States
PinnacleHealth Cancer Institute
Jacksville, Pennsylvania, 17050, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
UPMC Shadyside Radiation Oncology
Pittsburgh, Pennsylvania, 15232, United States
MUSC- Rutledge Tower
Charleston, South Carolina, 29403, United States
Medical University of South Carolina- Hollings Cancer Center
Charleston, South Carolina, 29425, United States
MUSC SCTR Research Nexus Clinical Science Building
Charleston, South Carolina, 29425, United States
MUSC- Ashley River Tower
Charleston, South Carolina, 29425, United States
MUSC- Radiation Oncology
Charleston, South Carolina, 29425, United States
MUSC- University Hospital
Charleston, South Carolina, 29425, United States
GHS Cancer Institute
Easley, South Carolina, 29640, United States
GHS Cancer Institute
Greenville, South Carolina, 29605, United States
GHS Cancer Institute
Greenville, South Carolina, 29615, United States
GHS Cancer Institute
Greer, South Carolina, 29650, United States
GHS Cancer Institute
Seneca, South Carolina, 29672, United States
GHS Cancer Institute
Spartanburg, South Carolina, 29307, United States
The West Clinic, PC dba West Cancer Center
Germantown, Tennessee, 38138, United States
The West Clinic PC dba West Cancer Center
Memphis, Tennessee, 38104, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232, United States
Texas Oncology El Paso Cancer Treatment Center
El Paso, Texas, 79902, United States
William Beaumont Army Medical Center
El Paso, Texas, 79920-5001, United States
William Beaumont Army Medical Center
El Paso, Texas, 79920, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Memorial Hermann Hospital - TMC
Houston, Texas, 77030, United States
UTHealth/Memorial Hermann Cancer Center
Houston, Texas, 77030, United States
UTMB Cancer Center at Victory Lakes
League City, Texas, 77573, United States
Utah Cancer Specialists
Murray, Utah, 84157, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
Chris O'Brien Lifehouse Medical Imaging
Camperdown, New South Wales, 2050, Australia
Chris O'Brien Lifehouse Radiation Oncology Department
Camperdown, New South Wales, 2050, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Northern Sydney Cancer Centre
St Leonards, New South Wales, 2065, Australia
Illawarra Shoalhaven Local Health District
Wollongong, New South Wales, 2500, Australia
Barwon Health, University Hospital Geelong
Geelong, Victoria, 3220, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Ordensklinikum Linz GmbH
Linz, A-4010, Austria
University Hospital Brussels
Brussels, 1090, Belgium
Grand Hopital de Charleroi - Site Notre-Dame
Charleroi, 6000, Belgium
Centre Hospitalier de Jolimont
Haine-Saint-Paul, 7100, Belgium
Site Sainte Elisabeth / CHU UCL Namur
Namur, 5000, Belgium
GZA Hospitals Campus Sint Augustinus
Wilrijk, 2610, Belgium
CHU de Quebec - Universite Laval
Québec, Quebec, G1R 2J6, Canada
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
SUN Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Cancer Center of Guangzhou Medical University/Oncology Department
Guangzhou, Guangdong, 510095, China
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Hai Nan General Hospital
Haikou, Hainan, 570311, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center
Wuhan, Hubei, 430030, China
Xiangya Hospital Central South University/Oncology Department
Changsha, Hunan, 410008, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Shanghai East Hospital/Oncology Department
Shanghai, Shanghai Municipality, 200123, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
Institut de Cancerologie de l'Ouest (ICO) - Site Paul Papin
Angers, 49055, France
Institut Sainte Catherine
Avignon, 84918, France
Hopital Pellegrin - Service de radiologie et d'imagerie
Bordeaux, 33075, France
Hopital Saint-Andre
Bordeaux, 33075, France
Cabinet de radiologie Privé - Dr Joseph Mocaer
Brest, 29220, France
Clinique Pasteur - CFRO
Brest, 29229, France
Hopital Franco-Britannique, Institut d'Oncologie Hauts-de-Seine Nord
Levallois-Perret, 92309, France
Institut Regional du Cancer Montpellier - Val d'Aurelle
Montpellier, 34298, France
Hopital prive du Confluent S.A.S.
Nantes, 44277, France
Hopital prive du Confluent S.A.S
Nantes, 44277, France
Clinique Hartmann
Neuilly-sur-Seine, 92200, France
Hopital Americain de Paris
Neuilly-sur-Seine, 92200, France
Centre Antoine Lacassagne
Nice, 06189, France
Institut Curie
Paris, 75005, France
Centre Hospitalier Prive Saint Gregoire
Saint-Grégoire, 35760, France
Institut de Cancerologie de l'Ouest (ICO) - Site Rene Gauducheau
Saint-Herblain, 44805, France
Institut de cancerologie de la Loire Lucien Neuwirth
Saint-Priest-en-Jarez, 42271, France
Centre Paul Strauss - Radiologie et medecine nucleaire
Strasbourg, 67065, France
ICANS - Institut de cancerologie Strasbourg Europe
Strasbourg, 67200, France
Institut Gustave Roussy
Villejuif, 94800, France
Helios Klinikum Berlin-Buch, Institut fur Rontgendiagnostik
Berlin, BUCH, 13125, Germany
Helios Klinikum Berlin-Buch, Klinik fur Nuklearmedizin
Berlin, BUCH, 13125, Germany
Helios Klinikum Berlin-Buch, Klinik fur Strahlentherapie
Berlin, BUCH, 13125, Germany
Helios Klinikum Berlin-Buch
Berlin, BUCH, 13125, Germany
Universitatsklinikum Dusseldorf
Düsseldorf, 40225, Germany
Universitatsklinikum Jena
Jena, 07745, Germany
Universitatsklinikum Jena
Jena, 07747, Germany
Universitätsklinikum Regensburg
Regensburg, 93042, Germany
General Oncology Hospital of Kifissia "Agioi Anargiroi"
Athens, Attica, 14564, Greece
Attikon University Hospital
Haidari, Attica, 12462, Greece
Euromedica General Clinic
Thessaloniki, 54645, Greece
Orszagos Onkologiai Intezet, B Belgyogyaszati Osztaly
Budapest, 1122, Hungary
Orszagos Onkologiai Intezet, Sugarterapias Osztaly
Budapest, 1122, Hungary
Uzsoki Utcai Korhaz
Budapest, 1145, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Petz Aladar Megyei Oktato Koraz, Onkoradiologiai osztaly
Győr, 9024, Hungary
Pecsi Tudomanyegyetem, Klinikai Kozpont, Onkoterapias Intezet
Pécs, 7624, Hungary
Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6720, Hungary
St Luke's Radiation Oncology Network, St Luke's Hospital
Dublin, 6, Ireland
St James's Hospital
Dublin, 8, Ireland
St. James's Hospital
Dublin, 8, Ireland
Blackrock Clinic
Dublin, A94 E4X7, Ireland
Rambam Health Care Campus
Haifa, 3109601, Israel
Hadassah University Hospital, Department of Oncology
Jerusalem, 91120, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
The Chaim Sheba M.C.Tel-Hashomer
Ramat Gan, 52621, Israel
ASST degli Spedali Civili di Brescia
Brescia, BS, 25123, Italy
Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (I.R.S.T)
Meldola, FC, 47014, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, 47014, Italy
Ospedale M. Bufalini
Cesena, Forlì-cesena, 47521, Italy
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, Forlì-cesena, 47014, Italy
Presidio Ospedaliero Vito Fazzi
Lecce, LE, 73100, Italy
AOU Policlinico Di Modena
Modena, MO, 41124, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, PR, 43126, Italy
UOC Oncologia Medica, AUSL della Romagna -RAVENNA
Lugo, RA, 48022, Italy
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Ravenna, RA, 48121, Italy
UOC Oncologia Medica, AUSL della Romagna - RAVENNA
Ravenna, RA, 48121, Italy
AULSS 9 - Scaligera Ospedale Mater Salutis
Legnago, VR, 37045, Italy
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
Napoli, 80131, Italy
AUSL - IRCCS and Reggio Emilia
Reggio Emilia, 42123, Italy
Aichi cancer center central hospital
Nagoya, Aichi-ken, 464-8681, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Miyagi Cancer Center
Natori-shi, Miyagi, 981-1293, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
Kindai University Hospital
Sayama, Osaka, 589-8511, Japan
Saitama Cancer Center
Kita-adachi-gun, Saitama, 362-0806, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 1040045, Japan
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550, Japan
Centrum Onkologii im. prof. F. Lukaszczyka
Bydgoszcz, 85-796, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie, Klinika Radioterapii i Chemioterapii
Gliwice, 44-101, Poland
SPZOZ Ministerstwa Spraw Wewnetrznych i Administracji z Warminsko-Mazurskim Centrum Onkologii
Olsztyn, 10-228, Poland
NZOZ Provita Prolife Centrum Medyczne
Tomaszów Mazowiecki, 97-200, Poland
Specjalistyczny Szpital Onkologiczny NU-MED sp. z o.o.
Tomaszów Mazowiecki, 97-200, Poland
Hospital Pedro Hispano
Matosinhos Municipality, Porto District, 4464-513, Portugal
CUF Porto
Senhora da Hora, Porto District, 4460-188, Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
Vila Nova de Gaia, Porto District, 4434-502, Portugal
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, E.P.E.
Coimbra, 3000-075, Portugal
Centro Hospitalar do Porto, E.P.E.- Hospital de Santo Antonio
Porto, 4099-001, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
Porto, 4200-072, Portugal
Centro Hospitalar São João, E.P.E
Porto, 4200-319, Portugal
Julio Teixeira
Porto, 4460-188, Portugal
SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
Chelyabinsk, 454087, Russia
N. N. Blokhin NMRCO
Moscow, 115478, Russia
Budgetary Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary"
Omsk, 644013, Russia
FSBI "National Medical Research Center of Oncology n.a. N.N. Petrov"
Saint Petersburg, 197758, Russia
SBIH "SPb Clinical Research Centre of Specialized Kinds of Medical Care (Oncology)"
Saint Petersburg, 197758, Russia
SBHI YaR "Regional Clinical Oncology Hospital"
Yaroslavl, 150054, Russia
Center for Proton Therapy, National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Center for Specific Organ Cancer, National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Department of Radiation Oncology, CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 13496, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, 58128, South Korea
Division of Radiation Oncology, Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Division of Radiation Oncology, Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
SMG-SNU Boramae Medical Center
Seoul, 07061, South Korea
Department of Radiation Oncology, Ulsan University Hospital
Ulsan, 44033, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Institut Catala d'Oncologia Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Hospital Costa del Sol
Marbella, Malaga, 29603, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Institut Catala D'Oncologia de Girona
Girona, 17007, Spain
Complejo Hospitalario de Jaen
Jaén, 23007, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, 46009, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Klinik fur Radiologie und Nuklearmedizin
Basel, Canton of Basel-City, 4031, Switzerland
Klinik fur Strahlentherapie und Radioonkologie
Basel, Canton of Basel-City, 4031, Switzerland
Universitatsspital Basel
Basel, Canton of Basel-City, 4031, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011, Switzerland
Kantonsspital Winterthur, Medizinische Onkologie
Winterthur, Canton of Zurich, 8401, Switzerland
Kantonsspital Winterthur, Radiologie
Winterthur, Canton of Zurich, 8401, Switzerland
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401, Switzerland
Istituto Oncologico della Svizzera Italiana IOSI, Ospedale San Giovanni
Bellinzona, Canton Ticino, 6500, Switzerland
Radiologia ORBV, Ospedale San Giovanni
Bellinzona, Canton Ticino, 6500, Switzerland
Institut fur Klinische Pathologie
Zurich, 8091, Switzerland
Klinik fur Nuklearmedizin
Zurich, 8091, Switzerland
Universitatsspital Zurich
Zurich, 8091, Switzerland
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112, Taiwan
Chang Gung Memorial Hospital-Linkou Branch
Taoyuan, 333, Taiwan
NHS Grampian
Aberdeen, AB25 2ZN, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, CH63 4JY, United Kingdom
University Hospital Bristol NHS Foundation Trust
Bristol, BS2 8ED, United Kingdom
NHS Lothian, Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Guy's and St. Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
Related Publications (1)
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.
PMID: 33794205DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2016
First Posted
November 2, 2016
Study Start
November 28, 2016
Primary Completion
December 23, 2019
Study Completion
August 25, 2020
Last Updated
September 22, 2021
Results First Posted
February 24, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.