AzTrials
AzTrials

Squamous Cell Carcinoma of the Head and NeckPhase 3NCT02952586

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 Phase 3 study testing Avelumab and Chemoradiation in people with Squamous Cell Carcinoma of the Head and Neck, run by Pfizer at 316 sites in 22 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Avelumab and Chemoradiation
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
697 participants
Where
316 sitesin 22 countries
Study dates
28 Nov 2016to 25 Aug 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Adequate bone marrow function
  • Adequate renal function
  • Adequate liver function
  • Pregnancy test (for patients of childbearing potential) negative at screening

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

316 sites in 22 countries.

316 sites in 22 countries

United States139 sites

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131

  • Lehigh Valley Health Network Cancer Center Pharmacy

    Allentown, Pennsylvania, 18103

  • Lehigh Valley Health Network-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Radiation Oncology Cancer Services

    Allentown, Pennsylvania, 18103

  • The Oncology Institute of Hope and Innovation

    Anaheim, California, 92801

  • Ashland-Bellefonte Cancer Center

    Ashland, Kentucky, 41101

  • Rocky Mountain Lions Eye Institute

    Aurora, Colorado, 80045

  • University of Colorado Denver CTO/CTRC

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Inpatient Pavilion

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Outpatient Pavilion

    Aurora, Colorado, 80045

  • University Of Colorado Hospital Cancer Center

    Aurora, Colorado, 80045

  • CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Maryland Proton Treatment Center

    Baltimore, Maryland, 21201

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • University of Maryland, Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Memorial Sloan Kettering Cancer Center-Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Lehigh Valley Health Network-Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Tower Hematology Oncology Medical Group

    Beverly Hills, California, 90211

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • MUSC- Rutledge Tower

    Charleston, South Carolina, 29403

  • Medical University of South Carolina- Hollings Cancer Center

    Charleston, South Carolina, 29425

  • MUSC SCTR Research Nexus Clinical Science Building

    Charleston, South Carolina, 29425

  • MUSC- Ashley River Tower

    Charleston, South Carolina, 29425

  • MUSC- Radiation Oncology

    Charleston, South Carolina, 29425

  • MUSC- University Hospital

    Charleston, South Carolina, 29425

  • Oncology Specialists of Charlotte, PA

    Charlotte, North Carolina, 28204

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28210

  • UCSD Radiation Oncology South Bay, Cancer Treatment Centers

    Chula Vista, California, 91914

  • Siteman Cancer Center- St. Peters

    City of Saint Peters, Missouri, 63376

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • University of Missouri- Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • Memorial Sloan Kettering Cancer Center Commack

    Commack, New York, 11725

  • Sylvester at Coral Gables

    Coral Gables, Florida, 33146

  • City of Hope Corona

    Corona, California, 92879

  • Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.

    Corona, California, 92879

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141

  • Sylvester at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Cypress Hematology & Oncology

    Denver, Colorado, 80210

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • The Oncology Institute of Hope and Innovation

    Downey, California, 90241

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, 91010

  • GHS Cancer Institute

    Easley, South Carolina, 29640

  • Texas Oncology El Paso Cancer Treatment Center

    El Paso, Texas, 79902

  • William Beaumont Army Medical Center

    El Paso, Texas, 79920-5001

  • William Beaumont Army Medical Center

    El Paso, Texas, 79920

  • Karmanos Cancer Institute

    Farmington Hills, Michigan, 48334

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Primary Healthcare Associates

    Flossmoor, Illinois, 60422

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • The West Clinic, PC dba West Cancer Center

    Germantown, Tennessee, 38138

  • Precision Cancer Research / Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • The Oncology Institute of Hope and Innovation

    Glendale, California, 91204

  • GHS Cancer Institute

    Greenville, South Carolina, 29605

  • GHS Cancer Institute

    Greenville, South Carolina, 29615

  • GHS Cancer Institute

    Greer, South Carolina, 29650

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • PinnacleHealth Cancer Institute

    Harrisburg, Pennsylvania, 17109

  • Memorial Sloan Kettering Cancer Center Westchester

    Harrison, New York, 10604

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Primary Healthcare Associates

    Harvey, Illinois, 60426

  • Specialist Global LLC

    Hialeah, Florida, 33012

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Memorial Hermann Hospital - TMC

    Houston, Texas, 77030

  • UTHealth/Memorial Hermann Cancer Center

    Houston, Texas, 77030

  • PinnacleHealth Cancer Institute

    Jacksville, Pennsylvania, 17050

  • Kansas City VA Medical Center

    Kansas City, Missouri, 64128

  • UC San Diego Medical Center- La Jolla (Thornton Hospital)

    La Jolla, California, 92037

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • IU Health Arnett Cancer Center

    Lafayette, Indiana, 47904

  • Hollis Cancer Center

    Lakeland, Florida, 33805

  • City of Hope Antelope Valley

    Lancaster, California, 93534

  • Herbert-Herman Cancer Center, Sparrow Hospital

    Lansing, Michigan, 48912

  • UTMB Cancer Center at Victory Lakes

    League City, Texas, 77573

  • The Oncology Institute of Hope and Innovation

    Long Beach, California, 90805

  • The Oncology Institute of Hope and Innovation

    Los Angeles, California, 90033

  • Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California, 90048

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Norton Hospital

    Louisville, Kentucky, 40202

  • University Medical Center, Inc.

    Louisville, Kentucky, 40202

  • Norton Brownsboro Hospital

    Louisville, Kentucky, 40241

  • Norton Cancer Institute

    Louisville, Kentucky, 40241

  • The Oncology Institute of Hope and Innovation

    Lynwood, California, 90262

  • The West Clinic PC dba West Cancer Center

    Memphis, Tennessee, 38104

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Memorial Sloan Kettering Cancer Center- Monmouth

    Middletown, New Jersey, 07748

  • The Oncology Institute of Hope and Innovation

    Montebello, California, 90640

  • Memorial Sloan Kettering Cancer Center- Bergen

    Montvale, New Jersey, 07645

  • Utah Cancer Specialists

    Murray, Utah, 84157

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232

  • Bellevue Hospital Center

    New York, New York, 10016

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • NYU Langone Medical Center

    New York, New York, 10016

  • NYU Langone Radiology

    New York, New York, 10016

  • NYU Langone Radiology - Ambulatory Care Center East 41st Street

    New York, New York, 10017

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10022

  • Memorial Sloan Kettering Cancer Center: Breast and Imaging Center

    New York, New York, 10065

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • OU Medical Center

    Oklahoma City, Oklahoma, 73104

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • University of Oklahoma Health Sciences Center- Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Department of Radiation Oncology Methodist Hospital

    Omaha, Nebraska, 68114

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68114

  • UC Irvine Medical Center

    Orange, California, 92868-3201

  • Kansas City VA Radiation Oncology Clinic

    Overland Park, Kansas, 66212

  • Cypress Hematology and Oncology

    Parker, Colorado, 80138

  • Memorial Cancer Institute at Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UPMC Shadyside Radiation Oncology

    Pittsburgh, Pennsylvania, 15232

  • Sylvester at Plantation

    Plantation, Florida, 33324

  • Highlands Cancer Center

    Prestonsburg, Kentucky, 41653

  • Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.

    Riverside, California, 92501

  • Highlands Oncology Group

    Rogers, Arkansas, 72758

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • UC San Diego Medical Center- Hillcrest

    San Diego, California, 92103

  • The Oncology Institute of Hope and Innovation

    Santa Ana, California, 92705

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • VA Puget Sound Health Care System

    Seattle, Washington, 98108

  • GHS Cancer Institute

    Seneca, South Carolina, 29672

  • City of Hope South Pasadena

    South Pasadena, California, 91030

  • GHS Cancer Institute

    Spartanburg, South Carolina, 29307

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington University School of Medicine Siteman Cancer Center

    St Louis, Missouri, 63110

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129

  • Stony Brook University

    Stony Brook, New York, 11794-7007

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Montefiore-Einstein Center for Cancer Care

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Primary Healthcare Associates

    Tinley Park, Illinois, 60477

  • The Oncology Institute of Hope and Innovation

    Torrance, California, 90503

  • Memorial Sloan Kettering Cancer Center- Nassau

    Uniondale, New York, 11553

  • The Oncology Institute of Hope and Innovation

    West Covina, California, 91790

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90602

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

France20 sites

  • Institut de Cancerologie de l'Ouest (ICO) - Site Paul Papin

    Angers, 49055

  • Institut Sainte Catherine

    Avignon, 84918

  • Hopital Pellegrin - Service de radiologie et d'imagerie

    Bordeaux, 33075

  • Hopital Saint-Andre

    Bordeaux, 33075

  • Cabinet de radiologie Privé - Dr Joseph Mocaer

    Brest, 29220

  • Clinique Pasteur - CFRO

    Brest, 29229

  • Hopital Franco-Britannique, Institut d'Oncologie Hauts-de-Seine Nord

    Levallois-Perret, 92309

  • Institut Regional du Cancer Montpellier - Val d'Aurelle

    Montpellier, 34298

  • Hopital prive du Confluent S.A.S.

    Nantes, 44277

  • Hopital prive du Confluent S.A.S

    Nantes, 44277

  • Clinique Hartmann

    Neuilly-sur-Seine, 92200

  • Hopital Americain de Paris

    Neuilly-sur-Seine, 92200

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut Curie

    Paris, 75005

  • Centre Hospitalier Prive Saint Gregoire

    Saint-Grégoire, 35760

  • Institut de Cancerologie de l'Ouest (ICO) - Site Rene Gauducheau

    Saint-Herblain, 44805

  • Institut de cancerologie de la Loire Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271

  • Centre Paul Strauss - Radiologie et medecine nucleaire

    Strasbourg, 67065

  • ICANS - Institut de cancerologie Strasbourg Europe

    Strasbourg, 67200

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

China16 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Xiangya Hospital Central South University/Oncology Department

    Changsha, Hunan, 410008

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • SUN Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Cancer Center of Guangzhou Medical University/Oncology Department

    Guangzhou, Guangdong, 510095

  • Hai Nan General Hospital

    Haikou, Hainan, 570311

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Affiliated Tumor Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Shanghai East Hospital/Oncology Department

    Shanghai, Shanghai Municipality, 200123

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center

    Wuhan, Hubei, 430030

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

Spain16 sites

  • Institut Catala d'Oncologia Badalona, Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Institut Catala D'Oncologia de Girona

    Girona, 17007

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Costa del Sol

    Marbella, Malaga, 29603

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, 46009

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Japan15 sites

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 1040045

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Saitama Cancer Center

    Kita-adachi-gun, Saitama, 362-0806

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • Cancer Institute Hospital, Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Aichi cancer center central hospital

    Nagoya, Aichi-ken, 464-8681

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Miyagi Cancer Center

    Natori-shi, Miyagi, 981-1293

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Kindai University Hospital

    Sayama, Osaka, 589-8511

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329-0498

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

Other trials in Japan

Italy14 sites

  • ASST degli Spedali Civili di Brescia

    Brescia, BS, 25123

  • Ospedale M. Bufalini

    Cesena, Forlì-cesena, 47521

  • Presidio Ospedaliero Vito Fazzi

    Lecce, LE, 73100

  • AULSS 9 - Scaligera Ospedale Mater Salutis

    Legnago, VR, 37045

  • UOC Oncologia Medica, AUSL della Romagna -RAVENNA

    Lugo, RA, 48022

  • Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (I.R.S.T)

    Meldola, FC, 47014

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

    Meldola, FC, 47014

  • IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

    Meldola, Forlì-cesena, 47014

  • AOU Policlinico Di Modena

    Modena, MO, 41124

  • Istituto Nazionale Tumori IRCCS - Fondazione Pascale

    Naples, 80131

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, PR, 43126

  • IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

    Ravenna, RA, 48121

  • UOC Oncologia Medica, AUSL della Romagna - RAVENNA

    Ravenna, RA, 48121

  • AUSL - IRCCS and Reggio Emilia

    Reggio Emilia, 42123

Other trials in Italy

South Korea12 sites

  • Center for Proton Therapy, National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Center for Specific Organ Cancer, National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do, 58128

  • Department of Radiation Oncology, CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, 13496

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Division of Radiation Oncology, Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Division of Radiation Oncology, Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • SMG-SNU Boramae Medical Center

    Seoul, 07061

  • Department of Radiation Oncology, Ulsan University Hospital

    Ulsan, 44033

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

Switzerland12 sites

  • Klinik fur Radiologie und Nuklearmedizin

    Basel, Canton of Basel-City, 4031

  • Klinik fur Strahlentherapie und Radioonkologie

    Basel, Canton of Basel-City, 4031

  • Universitatsspital Basel

    Basel, Canton of Basel-City, 4031

  • Istituto Oncologico della Svizzera Italiana IOSI, Ospedale San Giovanni

    Bellinzona, Canton Ticino, 6500

  • Radiologia ORBV, Ospedale San Giovanni

    Bellinzona, Canton Ticino, 6500

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Canton of Vaud, 1011

  • Kantonsspital Winterthur, Medizinische Onkologie

    Winterthur, Canton of Zurich, 8401

  • Kantonsspital Winterthur, Radiologie

    Winterthur, Canton of Zurich, 8401

  • Kantonsspital Winterthur

    Winterthur, Canton of Zurich, 8401

  • Institut fur Klinische Pathologie

    Zurich, 8091

  • Klinik fur Nuklearmedizin

    Zurich, 8091

  • Universitatsspital Zurich

    Zurich, 8091

Other trials in Switzerland

Germany8 sites

  • Helios Klinikum Berlin-Buch, Institut fur Rontgendiagnostik

    Berlin, BUCH, 13125

  • Helios Klinikum Berlin-Buch, Klinik fur Nuklearmedizin

    Berlin, BUCH, 13125

  • Helios Klinikum Berlin-Buch, Klinik fur Strahlentherapie

    Berlin, BUCH, 13125

  • Helios Klinikum Berlin-Buch

    Berlin, BUCH, 13125

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225

  • Universitatsklinikum Jena

    Jena, 07745

  • Universitatsklinikum Jena

    Jena, 07747

  • Universitätsklinikum Regensburg

    Regensburg, 93042

Other trials in Germany

Portugal8 sites

  • Instituto Portugues de Oncologia de Coimbra Francisco Gentil, E.P.E.

    Coimbra, 3000-075

  • Hospital Pedro Hispano

    Matosinhos Municipality, Porto District, 4464-513

  • Centro Hospitalar do Porto, E.P.E.- Hospital de Santo Antonio

    Porto, 4099-001

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.

    Porto, 4200-072

  • Centro Hospitalar São João, E.P.E

    Porto, 4200-319

  • Julio Teixeira

    Porto, 4460-188

  • CUF Porto

    Senhora da Hora, Porto District, 4460-188

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

Australia7 sites

  • Chris O'Brien Lifehouse Medical Imaging

    Camperdown, New South Wales, 2050

  • Chris O'Brien Lifehouse Radiation Oncology Department

    Camperdown, New South Wales, 2050

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Barwon Health, University Hospital Geelong

    Geelong, Victoria, 3220

  • Austin Health

    Heidelberg, Victoria, 3084

  • Northern Sydney Cancer Centre

    St Leonards, New South Wales, 2065

  • Illawarra Shoalhaven Local Health District

    Wollongong, New South Wales, 2500

Other trials in Australia

Hungary7 sites

  • Orszagos Onkologiai Intezet, B Belgyogyaszati Osztaly

    Budapest, 1122

  • Orszagos Onkologiai Intezet, Sugarterapias Osztaly

    Budapest, 1122

  • Uzsoki Utcai Korhaz

    Budapest, 1145

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Petz Aladar Megyei Oktato Koraz, Onkoradiologiai osztaly

    Győr, 9024

  • Pecsi Tudomanyegyetem, Klinikai Kozpont, Onkoterapias Intezet

    Pécs, 7624

  • Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6720

Other trials in Hungary

Taiwan7 sites

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Chang Gung Memorial Hospital-Linkou Branch

    Taoyuan City, 333

Other trials in Taiwan

Poland6 sites

  • Centrum Onkologii im. prof. F. Lukaszczyka

    Bydgoszcz, 85-796

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie, Klinika Radioterapii i Chemioterapii

    Gliwice, 44-101

  • SPZOZ Ministerstwa Spraw Wewnetrznych i Administracji z Warminsko-Mazurskim Centrum Onkologii

    Olsztyn, 10-228

  • NZOZ Provita Prolife Centrum Medyczne

    Tomaszów Mazowiecki, 97-200

  • Specjalistyczny Szpital Onkologiczny NU-MED sp. z o.o.

    Tomaszów Mazowiecki, 97-200

Other trials in Poland

Russia6 sites

  • SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"

    Chelyabinsk, 454087

  • N. N. Blokhin NMRCO

    Moscow, 115478

  • Budgetary Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary"

    Omsk, 644013

  • FSBI "National Medical Research Center of Oncology n.a. N.N. Petrov"

    Saint Petersburg, 197758

  • SBIH "SPb Clinical Research Centre of Specialized Kinds of Medical Care (Oncology)"

    Saint Petersburg, 197758

  • SBHI YaR "Regional Clinical Oncology Hospital"

    Yaroslavl, 150054

Other trials in Russia

Belgium5 sites

  • University Hospital Brussels

    Brussels, 1090

  • Grand Hopital de Charleroi - Site Notre-Dame

    Charleroi, 6000

  • Centre Hospitalier de Jolimont

    Haine-Saint-Paul, 7100

  • Site Sainte Elisabeth / CHU UCL Namur

    Namur, 5000

  • GZA Hospitals Campus Sint Augustinus

    Wilrijk, 2610

Other trials in Belgium

United Kingdom5 sites

  • NHS Grampian

    Aberdeen, AB25 2ZN

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, CH63 4JY

  • University Hospital Bristol NHS Foundation Trust

    Bristol, BS2 8ED

  • NHS Lothian, Western General Hospital

    Edinburgh, EH4 2XU

  • Guy's and St. Thomas' NHS Foundation Trust

    London, SE1 9RT

Other trials in United Kingdom

Ireland4 sites

  • St Luke's Radiation Oncology Network, St Luke's Hospital

    Dublin, 6

  • St James's Hospital

    Dublin, 8

  • St. James's Hospital

    Dublin, 8

  • Blackrock Clinic

    Dublin, A94 E4X7

Other trials in Ireland

Israel4 sites

  • Rambam Health Care Campus

    Haifa, 3109601

  • Hadassah University Hospital, Department of Oncology

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 4941492

  • The Chaim Sheba M.C.Tel-Hashomer

    Ramat Gan, 52621

Other trials in Israel

Greece3 sites

  • General Oncology Hospital of Kifissia "Agioi Anargiroi"

    Athens, Attica, 14564

  • Attikon University Hospital

    Haidari, Attica, 12462

  • Euromedica General Clinic

    Thessaloniki, 54645

Other trials in Greece

Austria1 site

  • Ordensklinikum Linz GmbH

    Linz, A-4010

Other trials in Austria

Canada1 site

  • CHU de Quebec - Universite Laval

    Québec, Quebec, G1R 2J6

Other trials in Canada

About this study

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

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.

Being tested
Avelumab, Chemoradiation
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AvelumabDrug

    Avelumab + SOC Chemoradiation

  • ChemoradiationOther

    Cisplatin + Radiation Therapy

Study groups in NCT02952586
Study groupRoleWhat they receive
Avelumab + SOC Chemoradiation TherapyExperimental* 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
Receives: Drug: Avelumab
Placebo + SOC CRTPlacebo 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
Receives: Other: Chemoradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From randomization until documented PD or death, censored date, whichever occurred first (up to 37 months)

Secondary outcomes (24)

  1. 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.

    Measured: From randomization to the date of death or censored date, whichever occurred first (up to 37 months)

  2. 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.

    Measured: From randomization until PD or death (up to 37 months)

  3. 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.

    Measured: From the date of randomization to the date of the first documentation of locoregional recurrence or death, whichever occurred first (up to 37 months)

  4. 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.

    Measured: From randomization until disease progression or death, whichever occurred first (up to 37 months)

  5. 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.

    Measured: From the date of randomization to the date of the first documentation of distant metastatic or death (up to 37 months)

  6. 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.

    Measured: 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)

  7. 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.

    Measured: Baseline up to 44 months

  8. 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.

    Measured: Baseline up to 15 months

  9. 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.

    Measured: 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)

  10. Change From Baseline in Vital Sign - Pulse Rate

    Change from baseline in pulse rate in sitting position in beats per minute was reported.

    Measured: 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)

  11. 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.

    Measured: 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)

  12. 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.

    Measured: 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)

  13. 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.

    Measured: 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)

  14. 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.

    Measured: Baseline (prior to first dose)

  15. 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).

    Measured: Baseline (prior to first dose)

  16. 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.

    Measured: From randomization until PD as per investigator assessment (up to 37 months)

  17. Maximum Plasma Concentration (Cmax) of Avelumab

    Maximum observed plasma concentration (Cmax) of Avelumab is reported.

    Measured: 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)

  18. Predose Plasma Concentration (Ctrough) of Avelumab

    Ctrough refers to plasma concentration of Avelumab observed just before treatment administration.

    Measured: 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)

  19. 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.

    Measured: Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase

  20. 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.

    Measured: Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase

  21. Maximum Plasma Concentration (Cmax) of Total and Free Cisplatin

    Maximum observed plasma concentration (Cmax) of total and free Cisplatin is reported.

    Measured: Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase

  22. 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.

    Measured: Pre-dose, mid-infusion, end of infusion, 3, 4, and 24 hours post dose on Day 1 of CRT phase

  23. 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)

    Measured: pre-dose on Day 1 up to 30 Days after the end of treatment

  24. Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status

    Measured: Day 1 of lead-in phase and on Days 8 and 25 of CRT phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2016 (estimated)
  2. Study start28 Nov 2016
  3. Primary completion23 Dec 2019
  4. Study completion25 Aug 2020

Why it stopped: The trial prematurely terminated as recommended by the E-DMC because the boundary for futility has been crossed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
697 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02952586
Sponsor's protocol ID
B9991016
Other IDs
2016-001456-21, LOCALLY ADVANCED HEAD AND NECK, 2016
Status last verified
Sep 2021
First submitted
31 Oct 2016
Last updated
22 Sep 2021
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

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.

    PubMed 33794205

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Avelumab and Chemoradiation in people with Squamous Cell Carcinoma of the Head and Neck, run by Pfizer at 316 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 316 sites in United States, France, China, Spain, Japan and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator (time frame: From randomization until documented PD or death, censored date, whichever occurred first (up to 37 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02952586, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.

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