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

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.

Study Overview

• Status: Terminated
• Conditions: Squamous Cell Carcinoma of the Head and Neck
• Intervention / Treatment: Drug: Avelumab; Other: Chemoradiation

• Study Type: Interventional
• Enrollment (Actual): 697
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse Medical Imaging
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse Radiation Oncology Department
    • St Leonards, New South Wales, Australia, 2065
      • Northern Sydney Cancer Centre
    • Wollongong, New South Wales, Australia, 2500
      • Illawarra Shoalhaven Local Health District
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • Barwon Health, University Hospital Geelong
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
• Austria
  • Linz, Austria, A-4010
    • Ordensklinikum Linz GmbH
• Belgium
  • Brussels, Belgium, 1090
    • University Hospital Brussels
  • Charleroi, Belgium, 6000
    • Grand Hôpital de Charleroi - Site Notre-Dame
  • Haine Saint Paul, Belgium, 7100
    • Centre Hospitalier de Jolimont
  • Namur, Belgium, 5000
    • Site Sainte Elisabeth / CHU UCL Namur
  • Wilrijk, Belgium, 2610
    • GZA Hospitals Campus Sint Augustinus
• Canada
  • Quebec, Canada, G1R 2J6
    • CHU de Québec - Université Laval
• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun yat-sen University Cancer Center
    • Guangzhou, Guangdong, China, 510095
      • Cancer Center of Guangzhou Medical University/Oncology Department
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Affiliated Tumor Hospital of Guangxi Medical University
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hai Nan General Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University/Oncology Department
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital & Institute
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai, China, 200123
      • Shanghai East Hospital/Oncology Department
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin cancer hospital
• France
  • Angers cedex 02, France, 49055
    • Institut de Cancérologie de l'Ouest (ICO) - Site Paul Papin
  • Avignon cedex 9, France, 84918
    • Institut Sainte Catherine
  • Bordeaux, France, 33075
    • Hôpital Saint-André
  • Bordeaux, France, 33075
    • Hopital Pellegrin - Service de radiologie et d'imagerie
  • Brest, France, 29220
    • Cabinet de radiologie Privé - Dr Joseph Mocaer
  • Brest, France, 29229
    • Clinique Pasteur - CFRO
  • Levallois-Perret, France, 92309
    • Hopital Franco-Britannique, Institut d'Oncologie Hauts-de-Seine Nord
  • Montpellier cedex 5, France, 34298
    • INSTITUT REGIONAL DU CANCER MONTPELLIER - Val D'Aurelle
  • Nantes cedex 2, France, 44277
    • Hôpital Privé du Confluent S.A.S.
  • Nantes cedex 2, France, 44277
    • Hopital prive du Confluent S.A.S
  • Neuilly Sur Seine, France, 92200
    • Hôpital Américain de Paris
  • Neuilly sur Seine, France, 92200
    • Clinique Hartmann
  • Nice cedex 2, France, 06189
    • Centre Antoine Lacassagne
  • Paris, France, 75005
    • Institut Curie
  • Saint Gregoire, France, 35760
    • Centre Hospitalier Privé Saint Grégoire
  • Saint Herblain Cedex, France, 44805
    • Institut de Cancerologie de l'Ouest (ICO) - Site Rene Gauducheau
  • Saint Priest en Jarez cedex, France, 42271
    • Institut de Cancérologie de la Loire Lucien Neuwirth
  • Strasbourg, France, 67200
    • ICANS - Institut de cancérologie Strasbourg Europe
  • Strasbourg Cedex, France, 67065
    • Centre Paul Strauss - Radiologie et medecine nucleaire
  • Villejuif, France, 94800
    • Institut Gustave Roussy
• Germany
  • Dusseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf
  • Jena, Germany, 07747
    • Universitätsklinikum Jena
  • Jena, Germany, 07745
    • Universitätsklinikum Jena
  • Regensburg, Germany, 93042
    • Universitätsklinikum Regensburg
  • Buch
    • Berlin, Buch, Germany, 13125
      • Helios Klinikum Berlin-Buch, Institut fur Rontgendiagnostik
    • Berlin, Buch, Germany, 13125
      • Helios Klinikum Berlin-Buch, Klinik fur Nuklearmedizin
    • Berlin, Buch, Germany, 13125
      • Helios Klinikum Berlin-Buch, Klinik fur Strahlentherapie
    • Berlin, Buch, Germany, 13125
      • Helios Klinikum Berlin-Buch
• Greece
  • Thessaloniki, Greece, 54645
    • Euromedica General Clinic
  • Attica
    • Athens, Attica, Greece, 14564
      • General Oncology Hospital of Kifissia "Agioi Anargiroi"
    • Haidari, Attica, Greece, 12462
      • Attikon University Hospital
• Hungary
  • Budapest, Hungary, 1145
    • Uzsoki Utcai Kórház
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet, B Belgyogyaszati Osztaly
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet, Sugarterapias Osztaly
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Gyor, Hungary, 9024
    • Petz Aladar Megyei Oktato Koraz, Onkoradiologiai osztaly
  • Pecs, Hungary, 7624
    • Pecsi Tudomanyegyetem, Klinikai Kozpont, Onkoterapias Intezet
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ
• Ireland
  • Dublin, Ireland, 8
    • St James's Hospital
  • Dublin, Ireland, 8
    • St. James's Hospital
  • Dublin, Ireland, 6
    • St Luke's Radiation Oncology Network, St Luke's Hospital
  • Dublin, Ireland, A94 E4X7
    • Blackrock Clinic
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Jerusalem, Israel, 91120
    • Hadassah University Hospital, Department of Oncology
  • Petah Tiqva, Israel, 4941492
    • Rabin Medical Center
  • Ramat Gan, Israel, 52621
    • The Chaim Sheba M.C.Tel-Hashomer
• Italy
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori IRCCS - Fondazione Pascale
  • Reggio Emilia, Italy, 42123
    • AUSL - IRCCS and Reggio Emilia
  • BS
    • Brescia, BS, Italy, 25123
      • ASST degli Spedali Civili di Brescia
  • FC
    • Meldola, FC, Italy, 47014
      • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
    • Meldola, FC, Italy, 47014
      • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T)
  • Forlì-cesena
    • Cesena, Forlì-cesena, Italy, 47521
      • Ospedale M. Bufalini
    • Meldola, Forlì-cesena, Italy, 47014
      • IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
  • LE
    • Lecce, LE, Italy, 73100
      • Presidio Ospedaliero Vito Fazzi
  • MO
    • Modena, MO, Italy, 41124
      • AOU Policlinico di Modena
  • PR
    • Parma, PR, Italy, 43126
      • Azienda Ospedaliero-Universitaria di Parma
  • RA
    • Lugo, RA, Italy, 48022
      • UOC Oncologia Medica, AUSL della Romagna -RAVENNA
    • Ravenna, RA, Italy, 48121
      • IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
    • Ravenna, RA, Italy, 48121
      • UOC Oncologia Medica, AUSL della Romagna - RAVENNA
  • VR
    • Legnago, VR, Italy, 37045
      • AULSS 9 - Scaligera Ospedale Mater Salutis
• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 466-8560
      • Nagoya University Hospital
    • Nagoya, Aichi, Japan, 464-8681
      • Aichi cancer center central hospital
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0017
      • Kobe University Hospital
  • Miyagi
    • Natori, Miyagi, Japan, 981-1293
      • Miyagi Cancer Center
    • Sendai, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Osaka
    • Osaka-shi, Osaka, Japan, 541-8567
      • Osaka International Cancer Institute
    • Osakasayama, Osaka, Japan, 589-8511
      • Kindai University Hospital
  • Saitama
    • Kita-adachi-gun, Saitama, Japan, 362-0806
      • Saitama Cancer Center
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • Tochigi
    • Shimotsuke, Tochigi, Japan, 329-0498
      • Jichi Medical University Hospital
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 1040045
      • National Cancer Center Hospital
    • Koto-ku, Tokyo, Japan, 135-8550
      • Cancer Institute Hospital, Japanese Foundation For Cancer Research
• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 07061
    • SMG-SNU Boramae Medical Center
  • Seoul, Korea, Republic of, 03080
    • Division of Radiation Oncology, Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Division of Radiation Oncology, Asan Medical Center
  • Ulsan, Korea, Republic of, 44033
    • Ulsan University Hospital
  • Ulsan, Korea, Republic of, 44033
    • Department of Radiation Oncology, Ulsan University Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • Center for Proton Therapy, National Cancer Center
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • Center for Specific Organ Cancer, National Cancer Center
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
      • Department of Radiation Oncology, CHA Bundang Medical Center, CHA University
  • Jeollanam-do
    • Hwasun-gun, Jeollanam-do, Korea, Republic of, 58128
      • Chonnam National University Hwasun Hospital
• Poland
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii im. prof. F. Lukaszczyka
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne
  • Gliwice, Poland, 44-101
    • Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie, Klinika Radioterapii i Chemioterapii
  • Olsztyn, Poland, 10-228
    • SPZOZ Ministerstwa Spraw Wewnetrznych i Administracji z Warminsko-Mazurskim Centrum Onkologii
  • Tomaszow Mazowiecki, Poland, 97-200
    • Nzoz Provita Prolife Centrum Medyczne
  • Tomaszow Mazowiecki, Poland, 97-200
    • Specjalistyczny Szpital Onkologiczny NU-MED Sp. z o.o.
• Portugal
  • Coimbra, Portugal, 3000-075
    • Instituto Português de Oncologia de Coimbra Francisco Gentil, E.P.E.
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto, E.P.E.- Hospital de Santo Antonio
  • Porto, Portugal, 4200-319
    • Centro Hospitalar São João, E.P.E
  • Porto, Portugal, 4460-188
    • Julio Teixeira
  • Porto
    • Matosinhos, Porto, Portugal, 4464-513
      • Hospital Pedro Hispano
    • Senhora da Hora, Porto, Portugal, 4460-188
      • CUF Porto
    • Vila Nova de Gaia, Porto, Portugal, 4434-502
      • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
• Russian Federation
  • Chelyabinsk, Russian Federation, 454087
    • SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
  • Moscow, Russian Federation, 115478
    • N. N. Blokhin NMRCO
  • Omsk, Russian Federation, 644013
    • Budgetary Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary"
  • Saint-Petersburg, Russian Federation, 197758
    • FSBI "National Medical Research Center of Oncology n.a. N.N. Petrov"
  • Saint-Petersburg, Russian Federation, 197758
    • SBIH "SPb Clinical Research Centre of Specialized Kinds of Medical Care (Oncology)"
  • Yaroslavl, Russian Federation, 150054
    • SBHI YaR "Regional Clinical Oncology Hospital"
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Girona, Spain, 17007
    • Institut Catala d'Oncologia de Girona
  • Jaen, Spain, 23007
    • Complejo Hospitalario de Jaen
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Malaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
  • Valencia, Spain, 46009
    • Fundación Instituto Valenciano de Oncología
  • Zaragoza, Spain, 50009
    • Hospital Clínico Universitario Lozano Blesa
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
  • Guipuzcoa
    • San Sebastian, Guipuzcoa, Spain, 20014
      • Hospital Universitario Donostia
  • Malaga
    • Marbella, Malaga, Spain, 29603
      • Hospital Costa Del Sol
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Clinico Universitario Virgen de La Arrixaca
• Switzerland
  • Zurich, Switzerland, 8091
    • Universitatsspital Zurich
  • Zurich, Switzerland, 8091
    • Institut fur Klinische Pathologie
  • Zurich, Switzerland, 8091
    • Klinik fur Nuklearmedizin
  • Basel-stadt
    • Basel, Basel-stadt, Switzerland, 4031
      • Klinik fur Radiologie und Nuklearmedizin
    • Basel, Basel-stadt, Switzerland, 4031
      • Klinik für Strahlentherapie und Radioonkologie
    • Basel, Basel-stadt, Switzerland, 4031
      • Universitätsspital Basel
  • Ticino
    • Bellinzona, Ticino, Switzerland, 6500
      • Istituto Oncologico della Svizzera Italiana IOSI, Ospedale San Giovanni
    • Bellinzona, Ticino, Switzerland, 6500
      • Radiologia ORBV, Ospedale San Giovanni
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois
  • Zuerich
    • Winterthur, Zuerich, Switzerland, 8401
      • Kantonsspital Winterthur, Medizinische Onkologie
  • Zurich
    • Winterthur, Zurich, Switzerland, 8401
      • Kantonsspital Winterthur
    • Winterthur, Zurich, Switzerland, 8401
      • Kantonsspital Winterthur, Radiologie
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 112
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taoyuan City, Taiwan, 333
    • Chang Gung Memorial Hospital-Linkou Branch
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • NHS Grampian
  • Bebington, United Kingdom, CH63 4JY
    • The Clatterbridge Cancer Centre NHS Foundation Trust
  • Bristol, United Kingdom, BS2 8ED
    • University Hospital Bristol NHS Foundation Trust
  • Edinburgh, United Kingdom, EH4 2XU
    • NHS Lothian, Western General Hospital
  • London, United Kingdom, SE1 9RT
    • Guy's and St. Thomas' NHS Foundation Trust
• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group
    • Rogers, Arkansas, United States, 72758
      • Highlands Oncology Group
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group
  • California
    • Anaheim, California, United States, 92801
      • The Oncology Institute of Hope and Innovation
    • Bakersfield, California, United States, 93309
      • CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
    • Beverly Hills, California, United States, 90211
      • Beverly Hills Cancer Center
    • Beverly Hills, California, United States, 90211
      • Tower Hematology Oncology Medical Group
    • Chula Vista, California, United States, 91914
      • UCSD Radiation Oncology South Bay, Cancer Treatment Centers
    • Corona, California, United States, 92879
      • City of Hope Corona
    • Corona, California, United States, 92879
      • Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
    • Downey, California, United States, 90241
      • The Oncology Institute of Hope and Innovation
    • Duarte, California, United States, 91010
      • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
    • Glendale, California, United States, 91204
      • The Oncology Institute of Hope and Innovation
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • La Jolla, California, United States, 92037
      • UC San Diego Medical Center- La Jolla (Thornton Hospital)
    • Lancaster, California, United States, 93534
      • City of Hope Antelope Valley
    • Long Beach, California, United States, 90805
      • The Oncology Institute of Hope and Innovation
    • Los Angeles, California, United States, 90033
      • The Oncology Institute of Hope and Innovation
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
    • Lynwood, California, United States, 90262
      • The Oncology Institute of Hope and Innovation
    • Montebello, California, United States, 90640
      • The Oncology Institute of Hope and Innovation
    • Orange, California, United States, 92868-3201
      • UC Irvine Medical Center
    • Riverside, California, United States, 92501
      • Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
    • San Diego, California, United States, 92103
      • UC San Diego Medical Center- Hillcrest
    • Santa Ana, California, United States, 92705
      • The Oncology Institute of Hope and Innovation
    • South Pasadena, California, United States, 91030
      • City of Hope South Pasadena
    • Torrance, California, United States, 90503
      • The Oncology Institute of Hope and Innovation
    • West Covina, California, United States, 91790
      • The Oncology Institute of Hope and Innovation
    • Whittier, California, United States, 90602
      • The Oncology Institute of Hope and Innovation
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Lions Eye Institute
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital - Anschutz Outpatient Pavilion
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver CTO/CTRC
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital - Anschutz Inpatient Pavilion
    • Aurora, Colorado, United States, 80045
      • University Of Colorado Hospital Cancer Center
    • Denver, Colorado, United States, 80210
      • Cypress Hematology & Oncology
    • Parker, Colorado, United States, 80138
      • Cypress Hematology and Oncology
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Sylvester at Coral Gables
    • Deerfield Beach, Florida, United States, 33442
      • Sylvester at Deerfield Beach
    • Hialeah, Florida, United States, 33012
      • Specialist Global LLC
    • Hollywood, Florida, United States, 33021
      • Memorial Cancer Institute at Memorial Regional Hospital
    • Lakeland, Florida, United States, 33805
      • Hollis Cancer Center
    • Miami, Florida, United States, 33136
      • Sylvester Comprehensive Cancer Center
    • Pembroke Pines, Florida, United States, 33028
      • Memorial Cancer Institute at Memorial Hospital West
    • Plantation, Florida, United States, 33324
      • Sylvester at Plantation
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute
  • Illinois
    • Flossmoor, Illinois, United States, 60422
      • Primary Healthcare Associates
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Harvey, Illinois, United States, 60426
      • Primary Healthcare Associates
    • Tinley Park, Illinois, United States, 60477
      • Primary Healthcare Associates
  • Indiana
    • Lafayette, Indiana, United States, 47904
      • IU Health Arnett Cancer Center
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Kansas City VA Radiation Oncology Clinic
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • Ashland-Bellefonte Cancer Center
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute
    • Louisville, Kentucky, United States, 40202
      • Norton Hospital
    • Louisville, Kentucky, United States, 40241
      • Norton Cancer Institute
    • Louisville, Kentucky, United States, 40202
      • University Medical Center, Inc.
    • Louisville, Kentucky, United States, 40241
      • Norton Brownsboro Hospital
    • Prestonsburg, Kentucky, United States, 41653
      • Highlands Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Greenebaum Comprehensive Cancer Center
    • Baltimore, Maryland, United States, 21201
      • Maryland Proton Treatment Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Farmington Hills, Michigan, United States, 48334
      • Karmanos Cancer Institute
    • Lansing, Michigan, United States, 48912
      • Herbert-Herman Cancer Center, Sparrow Hospital
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri- Ellis Fischel Cancer Center
    • Creve Coeur, Missouri, United States, 63141
      • Siteman Cancer Center - West County
    • Kansas City, Missouri, United States, 64128
      • Kansas City VA Medical Center
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
    • Saint Louis, Missouri, United States, 63129
      • Siteman Cancer Center - South County
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine Siteman Cancer Center
    • Saint Peters, Missouri, United States, 63376
      • Siteman Cancer Center- St. Peters
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Department of Radiation Oncology Methodist Hospital
    • Omaha, Nebraska, United States, 68114
      • Oncology Hematology West, PC dba Nebraska Cancer Specialists
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Cancer Center-Basking Ridge
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack University Medical Center
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Cancer Center- Monmouth
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Cancer Center- Bergen
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Comprehensive Cancer Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Bronx, New York, United States, 10461
      • Montefiore-Einstein Center for Cancer Care
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Cancer Center Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Cancer Center Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10022
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    • New York, New York, United States, 10016
      • Bellevue Hospital Center
    • New York, New York, United States, 10016
      • NYU Langone Radiology
    • New York, New York, United States, 10017
      • NYU Langone Radiology - Ambulatory Care Center East 41st Street
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center: Breast and Imaging Center
    • Stony Brook, New York, United States, 11794-7007
      • Stony Brook University
    • Stony Brook, New York, United States, 11794
      • Stony Brook Cancer Center
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Cancer Center- Nassau
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • DJL Clinical Research, PLLC
    • Charlotte, North Carolina, United States, 28204
      • Oncology Specialists of Charlotte, PA
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • OU Medical Center
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center- Stephenson Cancer Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network Cancer Center Pharmacy
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network-Cedar Crest
    • Allentown, Pennsylvania, United States, 18103
      • Radiation Oncology Cancer Services
    • Bethlehem, Pennsylvania, United States, 18017
      • Lehigh Valley Health Network-Muhlenberg
    • Gettysburg, Pennsylvania, United States, 17325
      • Precision Cancer Research / Gettysburg Cancer Center
    • Harrisburg, Pennsylvania, United States, 17109
      • PinnacleHealth Cancer Institute
    • Mechancisburg, Pennsylvania, United States, 17050
      • PinnacleHealth Cancer Institute
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Shadyside Radiation Oncology
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC- Ashley River Tower
    • Charleston, South Carolina, United States, 29403
      • MUSC- Rutledge Tower
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina- Hollings Cancer Center
    • Charleston, South Carolina, United States, 29425
      • MUSC SCTR Research Nexus Clinical Science Building
    • Charleston, South Carolina, United States, 29425
      • MUSC- Radiation Oncology
    • Charleston, South Carolina, United States, 29425
      • MUSC- University Hospital
    • Easley, South Carolina, United States, 29640
      • GHS Cancer Institute
    • Greenville, South Carolina, United States, 29615
      • GHS Cancer Institute
    • Greenville, South Carolina, United States, 29605
      • GHS Cancer Institute
    • Greer, South Carolina, United States, 29650
      • GHS Cancer Institute
    • Seneca, South Carolina, United States, 29672
      • GHS Cancer Institute
    • Spartanburg, South Carolina, United States, 29307
      • GHS Cancer Institute
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic, PC dba West Cancer Center
    • Memphis, Tennessee, United States, 38104
      • The West Clinic PC dba West Cancer Center
    • Nashville, Tennessee, United States, 37232
      • Henry-Joyce Cancer Clinic
  • Texas
    • El Paso, Texas, United States, 79920
      • William Beaumont Army Medical Center
    • El Paso, Texas, United States, 79920-5001
      • William Beaumont Army Medical Center
    • El Paso, Texas, United States, 79902
      • Texas Oncology El Paso Cancer Treatment Center
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital - TMC
    • Houston, Texas, United States, 77030
      • UTHealth/Memorial Hermann Cancer Center
    • League City, Texas, United States, 77573
      • UTMB Cancer Center at Victory Lakes
  • Utah
    • Murray, Utah, United States, 84157
      • Utah Cancer Specialists
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avelumab + SOC Chemoradiation Therapy; 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	Drug: Avelumab; Avelumab + SOC Chemoradiation
Placebo Comparator: Placebo + SOC CRT; 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	Other: Chemoradiation; Cisplatin + Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan Meier method.	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	pCR was defined as the absence of histologically identifiable residual cancer in any resected specimen. The pCR rate at primary site was estimated by dividing the number of participants with pCR recorded at any visit from randomization until PD per modified RECIST v1.1 or death due to any cause by the number of participants randomized who had 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	Locoregional failure was defined as the time from the date of randomization to the date of the first documentation of locoregional recurrence or death due to any cause per modified RECIST v1.1 as assessed by Investigator, whichever occurred first. Analysis was performed using Kaplan Meier method.	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	Objective response (OR) was defined as a complete response (CR) or partial response (PR) per RECIST v1.1 recorded from randomization until disease progression per modified RECIST v1.1 or death due to any cause. A participant was considered to have achieved an OR if the participant had a CR or PR which did not need to be confirmed at a subsequent assessment. CR for target disease: complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis less than [<] 10 millimeter [mm]). CR for non-target disease: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be 'normal' in size (<10 mm short axis) . PR: Greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target measurable lesions. The ORR was estimated by dividing the number of participants with OR (CR or PR) by the number of participants randomized.	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	Time to distant metastatic failure or distant metastasis (DM) was defined as the time from the date of randomization to the date of the first documentation of distant metastatic or death due to any cause, whichever occurred first. Distant metastatic disease was defined as new tumor identified at a site distant from the head and neck anatomic region or draining lymph nodes. Analysis was performed using Kaplan Meier method.	From the date of randomization to the date of the first documentation of distant metastatic or death (up to 37 months)
Duration of Response (DOR) Per Modified RECIST v1.1 as Assessed by Investigator	DOR:time from first documentation of objective tumor response (CR/PR) to first documentation of PD/death due to any cause, whichever occurred first.PR:>=30% decrease under baseline of sum of diameters of all target measurable lesions. CR for target disease:complete disappearance of all target lesions with exception of nodal disease.CR for non-target disease: disappearance of all non-target lesions and normalization of tumor marker levels. PD is any of following:1)Locoregional PD confirmed by pathology to verify radiographic changes denote true tumor progression and not radiation effects or non-malignant contrast enhancement.2)Locoregional clinically detectable progression confirmed by pathology.3)Surgical removal of primary tumor with tumor present on final pathology.4)Salvage neck dissection >20 weeks after completion of CRT with tumor present on final pathology.5)Metastatic PD. DOR data was censored on date of last adequate tumor assessment for participants with no overall response.	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)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03	Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. TEAE was defined as event with onset dates occurring during the on-treatment period.	Baseline up to 44 months
Number of Participants With Shift From Baseline in Clinical Laboratory Parameters	Grade 1 and 3 ranges are: Anemia:Hb:<LLN-10.0,<8.0 g/dL;LC decreased (dec):<LLN-800/mm^3,500-200/mm^3;LC increased (inc):grade 3:>20,000/mm^3:NC dec:<LLN-1500/mm^3;<1000-500/mm^3;PC dec:<LLN-75,000/mm^3;<50,000-25,000/mm^3;WBC dec:<LLN-3000/mm^3;<2000-1000/mm^3;ALT inc:>ULN-3.0*ULN;>5.0-20.0*ULN;ALP & GGT inc:>ULN-2.5*ULN;>5.0-20.0*ULN;AST inc:>ULN-3.0*ULN;>5.0-20.0*ULN;BB inc:>ULN-1.5*ULN;>3.0-10.0*ULN;CH high:>ULN-300 mg/dL;>400-500 mg/dL;CPK inc:>ULN-2.5*ULN;>5*ULN-10*ULN;Hypercalcemia:>ULN-11.5;>12.5-13.5mg/dL;Hyperglycemia:>ULN-160; >250-500mg/dL;Hyperkalemia:>ULN-5.5;>6.0-7.0mmol/L;Hypermagnesemia:>ULN-3.0;>3.0-8.0 mg/dL;Hypernatremia:>ULN-150; >155-160 mmol/L;Hypertriglyceridemia;150-300;>500-1000 mg/dL;Hypoalbuminemia:<LLN-3;<2g/dL;Hypocalcemia:<LLN-8.0;<8.0-7.0mg/dL;Hypokalemia:<LLN-3.0;<3.0-2.5mmol/L;Hypomagnesemia;<LLN-1.2;<0.9-0.7 mg/dL;Hyponatremia:<LLN-130;<130-120mmol/L; Hypophosphatemia:<LLN-2.5;<2.0-1.0mg/dL;lipase & serum amylase inc:>ULN-1.5*ULN;>2.0-5.0*ULN.	Baseline up to 15 months
Change From Baseline in Vital Sign - Systolic and Diastolic Blood Pressure	Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) measured in sitting position were reported.	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)
Change From Baseline in Vital Sign - Pulse Rate	Change from baseline in pulse rate in sitting position in beats per minute was reported.	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)
Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Index Score at CRT Phase and Maintenance Phase	EQ-5D-5L is a standardized participant completed questionnaire that measures health status in terms of a single index value or utility score. EQ-5D-5L consisted of two components: a health state profile (descriptive system) and a visual analogue scale (VAS) in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable), where higher scores indicated better health status. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L health status index score range between 0 to 1. Higher score indicated better health status.	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)
Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) VAS Score at CRT Phase and Maintenance Phase	EQ-5D-5L is a standardized participant completed questionnaire that measures health status in terms of a single index value or utility score. EQ-5D-5L consisted of two components: a health state profile (descriptive system) and a visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L health status index score range between 0 to 1. Higher score indicated worse health status. In VAS participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable), where higher scores indicated better health status.	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)
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	The NCCN FHNSI-22 questionnaire measured disease symptoms, treatment side effects and overall quality of life in participants with head and neck cancer. The questionnaire contained 22 items with 5-point Likert scales ranging from 0 to 4 as follows: 'not at all = 0', a little bit = 1, somewhat = 2, quite a bit = 3 and very much = 4. Total score ranged from 0 to 88 where, higher scores represented better symptomatology, quality of life or functioning.	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)
Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)	PD-L1 biomarker expression in tumor tissue as assessed by IHC in the form of positive immune cells and tumor staining cells.	Baseline (prior to first dose)
Mean Percentage (%) of Total Tumor Area Occupied by Cluster of Differentiation 8 (CD8+) Cells	Description: CD8+ cells are the type of T-lymphocytes. Mean percentage of total tumor area occupied by CD8+ Cells has been reported. Area was measured in millimeter square (mm^2).	Baseline (prior to first dose)
Percentage of Participants With Positive and Negative Pathology of Neck Dissection	Percentage of participants with positive and negative pathology of neck dissection were reported. Positive pathology included live tumor cells present or 10% or greater vital tumor tissues. Negative pathology included no live tumor cells present, complete tumor regression, no evidence of vital tumor tissues, less than 10% vital tumor tissue, or not consistent with disease under study.	From randomization until PD as per investigator assessment (up to 37 months)
Maximum Plasma Concentration (Cmax) of Avelumab	Maximum observed plasma concentration (Cmax) of Avelumab is reported.	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)
Predose Plasma Concentration (Ctrough) of Avelumab	Ctrough refers to plasma concentration of Avelumab observed just before treatment administration.	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)
Dose Normalized Maximum Plasma Concentration (Cmax [dn]) of Total and Free Cisplastin	Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of total and free Cisplastin (in mg) administered to a participant.	Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of Total and Free Cisplatin	Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast). AUClast (dn) was calculated by dividing AUClast by the exact dose of cisplastin (in mg) administered to a participant.	Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
Maximum Plasma Concentration (Cmax) of Total and Free Cisplatin	Maximum observed plasma concentration (Cmax) of total and free Cisplatin is reported.	Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
Time to Attain Maximum Observed Plasma Concentration (Tmax) of Total and Free Cisplatin	Time to reach maximum observed plasma concentration (Tmax) of total and free Cisplatin.	Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase
Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status	ADA never-positive was defined as no positive ADA results at any time point; ADA-negative participants (titer less than< cut point) and ADA ever-positive was defined as at least one positive ADA result at any time point; ADA-positive participants (titer greater than or equal to cut point)	pre-dose on Day 1 up to 30 Days after the end of treatment
Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status		Day 1 of lead-in phase and on Days 8 and 25 of CRT phase

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2016
• Primary Completion (Actual): December 23, 2019
• Study Completion (Actual): August 25, 2020

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Antineoplastic Agents; Antineoplastic Agents, Immunological; Avelumab
• Other Study ID Numbers: B9991016; 2016-001456-21 (EudraCT Number); LOCALLY ADVANCED HEAD AND NECK (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.