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)

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02952586
• Other study ID #: B9991016
• Secondary ID: 2016-001456-21LO
• Status: Terminated
• Phase: Phase 3
• Start date: November 28, 2016
• Est. completion date: August 25, 2020

Study information

• Verified date: September 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 697
• Est. completion date: August 25, 2020
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Drug:
• Avelumab
Avelumab + SOC Chemoradiation

Other:
• Chemoradiation
Cisplatin + Radiation Therapy

Locations

Country	Name	City	State
Australia	Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	Chris O'Brien Lifehouse Medical Imaging	Camperdown	New South Wales
Australia	Chris O'Brien Lifehouse Radiation Oncology Department	Camperdown	New South Wales
Australia	Barwon Health, University Hospital Geelong	Geelong	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	Northern Sydney Cancer Centre	St Leonards	New South Wales
Australia	Illawarra Shoalhaven Local Health District	Wollongong	New South Wales
Austria	Ordensklinikum Linz GmbH	Linz
Belgium	University Hospital Brussels	Brussels
Belgium	Grand Hopital de Charleroi - Site Notre-Dame	Charleroi
Belgium	Centre Hospitalier de Jolimont	Haine Saint Paul
Belgium	Site Sainte Elisabeth / CHU UCL Namur	Namur
Belgium	GZA Hospitals Campus Sint Augustinus	Wilrijk
Canada	CHU de Quebec - Universite Laval	Quebec
China	Beijing Cancer Hospital	Beijing	Beijing
China	Xiangya Hospital Central South University/Oncology Department	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Cancer Center of Guangzhou Medical University/Oncology Department	Guangzhou	Guangdong
China	SUN Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Hai Nan General Hospital	Haikou	Hainan
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Affiliated Tumor Hospital of Guangxi Medical University	Nanning	Guangxi
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Shanghai East Hospital/Oncology Department	Shanghai	Shanghai
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning
China	Tianjin Cancer Hospital	Tianjin	Tianjin
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center	Wuhan	Hubei
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan
France	Institut de Cancerologie de l'Ouest (ICO) - Site Paul Papin	Angers cedex 02
France	Institut Sainte Catherine	Avignon cedex 9
France	Hopital Pellegrin - Service de radiologie et d'imagerie	Bordeaux
France	Hopital Saint-Andre	Bordeaux
France	Cabinet de radiologie Privé - Dr Joseph Mocaer	Brest
France	Clinique Pasteur - CFRO	Brest
France	Hopital Franco-Britannique, Institut d'Oncologie Hauts-de-Seine Nord	Levallois-Perret
France	Institut Regional du Cancer Montpellier - Val d'Aurelle	Montpellier cedex 5
France	Hopital prive du Confluent S.A.S	Nantes cedex 2
France	Hopital prive du Confluent S.A.S.	Nantes cedex 2
France	Clinique Hartmann	Neuilly sur Seine
France	Hopital Americain de Paris	Neuilly Sur Seine
France	Centre Antoine Lacassagne	Nice cedex 2
France	Institut Curie	Paris
France	Centre Hospitalier Prive Saint Gregoire	Saint Gregoire
France	Institut de Cancerologie de l'Ouest (ICO) - Site Rene Gauducheau	Saint Herblain Cedex
France	Institut de cancerologie de la Loire Lucien Neuwirth	Saint Priest en Jarez cedex
France	ICANS - Institut de cancerologie Strasbourg Europe	Strasbourg
France	Centre Paul Strauss - Radiologie et medecine nucleaire	Strasbourg Cedex
France	Institut Gustave Roussy	Villejuif
Germany	Helios Klinikum Berlin-Buch	Berlin	Buch
Germany	Helios Klinikum Berlin-Buch, Institut fur Rontgendiagnostik	Berlin	Buch
Germany	Helios Klinikum Berlin-Buch, Klinik fur Nuklearmedizin	Berlin	Buch
Germany	Helios Klinikum Berlin-Buch, Klinik fur Strahlentherapie	Berlin	Buch
Germany	Universitatsklinikum Dusseldorf	Dusseldorf
Germany	Universitatsklinikum Jena	Jena
Germany	Universitatsklinikum Jena	Jena
Germany	Universitätsklinikum Regensburg	Regensburg
Greece	General Oncology Hospital of Kifissia "Agioi Anargiroi"	Athens	Attica
Greece	Attikon University Hospital	Haidari	Attica
Greece	Euromedica General Clinic	Thessaloniki
Hungary	Orszagos Onkologiai Intezet, B Belgyogyaszati Osztaly	Budapest
Hungary	Orszagos Onkologiai Intezet, Sugarterapias Osztaly	Budapest
Hungary	Uzsoki Utcai Korhaz	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Petz Aladar Megyei Oktato Koraz, Onkoradiologiai osztaly	Gyor
Hungary	Pecsi Tudomanyegyetem, Klinikai Kozpont, Onkoterapias Intezet	Pecs
Hungary	Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont	Szeged
Ireland	Blackrock Clinic	Dublin
Ireland	St James's Hospital	Dublin
Ireland	St Luke's Radiation Oncology Network, St Luke's Hospital	Dublin
Ireland	St. James's Hospital	Dublin
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah University Hospital, Department of Oncology	Jerusalem
Israel	Rabin Medical Center	Petah Tiqva
Israel	The Chaim Sheba M.C.Tel-Hashomer	Ramat Gan
Italy	ASST degli Spedali Civili di Brescia	Brescia	BS
Italy	Ospedale M. Bufalini	Cesena	Forlì-cesena
Italy	Presidio Ospedaliero Vito Fazzi	Lecce	LE
Italy	AULSS 9 - Scaligera Ospedale Mater Salutis	Legnago	VR
Italy	UOC Oncologia Medica, AUSL della Romagna -RAVENNA	Lugo	RA
Italy	IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)	Meldola	Forlì-cesena
Italy	Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (I.R.S.T)	Meldola	FC
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)	Meldola	FC
Italy	AOU Policlinico Di Modena	Modena	MO
Italy	Istituto Nazionale Tumori IRCCS - Fondazione Pascale	Napoli
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma	PR
Italy	IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)	Ravenna	RA
Italy	UOC Oncologia Medica, AUSL della Romagna - RAVENNA	Ravenna	RA
Italy	AUSL - IRCCS and Reggio Emilia	Reggio Emilia
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Saitama Cancer Center	Kita-adachi-gun	Saitama
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	Cancer Institute Hospital, Japanese Foundation for Cancer Research	Koto-ku	Tokyo
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama	Ehime
Japan	Aichi cancer center central hospital	Nagoya	Aichi
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Miyagi Cancer Center	Natori	Miyagi
Japan	Osaka International Cancer Institute	Osaka-shi	Osaka
Japan	Kindai University Hospital	Osakasayama	Osaka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Shizuoka Cancer Center	Sunto-gun	Shizuoka
Korea, Republic of	Center for Proton Therapy, National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Center for Specific Organ Cancer, National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-gun	Jeollanam-do
Korea, Republic of	Department of Radiation Oncology, CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Division of Radiation Oncology, Asan Medical Center	Seoul
Korea, Republic of	Division of Radiation Oncology, Seoul National University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	Department of Radiation Oncology, Ulsan University Hospital	Ulsan
Korea, Republic of	Ulsan University Hospital	Ulsan
Poland	Centrum Onkologii im. prof. F. Lukaszczyka	Bydgoszcz
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie, Klinika Radioterapii i Chemioterapii	Gliwice
Poland	SPZOZ Ministerstwa Spraw Wewnetrznych i Administracji z Warminsko-Mazurskim Centrum Onkologii	Olsztyn
Poland	NZOZ Provita Prolife Centrum Medyczne	Tomaszow Mazowiecki
Poland	Specjalistyczny Szpital Onkologiczny NU-MED sp. z o.o.	Tomaszow Mazowiecki
Portugal	Instituto Portugues de Oncologia de Coimbra Francisco Gentil, E.P.E.	Coimbra
Portugal	Hospital Pedro Hispano	Matosinhos	Porto
Portugal	Centro Hospitalar do Porto, E.P.E.- Hospital de Santo Antonio	Porto
Portugal	Centro Hospitalar São João, E.P.E	Porto
Portugal	Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.	Porto
Portugal	Julio Teixeira	Porto
Portugal	CUF Porto	Senhora da Hora	Porto
Portugal	Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE	Vila Nova de Gaia	Porto
Russian Federation	SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"	Chelyabinsk
Russian Federation	N. N. Blokhin NMRCO	Moscow
Russian Federation	Budgetary Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary"	Omsk
Russian Federation	FSBI "National Medical Research Center of Oncology n.a. N.N. Petrov"	Saint-Petersburg
Russian Federation	SBIH "SPb Clinical Research Centre of Specialized Kinds of Medical Care (Oncology)"	Saint-Petersburg
Russian Federation	SBHI YaR "Regional Clinical Oncology Hospital"	Yaroslavl
Spain	Institut Catala d'Oncologia Badalona, Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital Clinico Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Institut Catala D'Oncologia de Girona	Girona
Spain	Complejo Hospitalario de Jaen	Jaen
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Virgen de la Victoria	Malaga
Spain	Hospital Costa del Sol	Marbella	Malaga
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Donostia	San Sebastian	Guipuzcoa
Spain	Fundacion Instituto Valenciano de Oncologia	Valencia
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza
Switzerland	Klinik fur Radiologie und Nuklearmedizin	Basel	Basel-stadt
Switzerland	Klinik fur Strahlentherapie und Radioonkologie	Basel	Basel-stadt
Switzerland	Universitatsspital Basel	Basel	Basel-stadt
Switzerland	Istituto Oncologico della Svizzera Italiana IOSI, Ospedale San Giovanni	Bellinzona	Ticino
Switzerland	Radiologia ORBV, Ospedale San Giovanni	Bellinzona	Ticino
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud
Switzerland	Kantonsspital Winterthur	Winterthur	Zurich
Switzerland	Kantonsspital Winterthur, Medizinische Onkologie	Winterthur	Zuerich
Switzerland	Kantonsspital Winterthur, Radiologie	Winterthur	Zurich
Switzerland	Institut fur Klinische Pathologie	Zurich
Switzerland	Klinik fur Nuklearmedizin	Zurich
Switzerland	Universitatsspital Zurich	Zurich
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital-Linkou Branch	Taoyuan City
United Kingdom	NHS Grampian	Aberdeen
United Kingdom	The Clatterbridge Cancer Centre NHS Foundation Trust	Bebington
United Kingdom	University Hospital Bristol NHS Foundation Trust	Bristol
United Kingdom	NHS Lothian, Western General Hospital	Edinburgh
United Kingdom	Guy's and St. Thomas' NHS Foundation Trust	London
United States	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico
United States	Lehigh Valley Health Network Cancer Center Pharmacy	Allentown	Pennsylvania
United States	Lehigh Valley Health Network-Cedar Crest	Allentown	Pennsylvania
United States	Radiation Oncology Cancer Services	Allentown	Pennsylvania
United States	The Oncology Institute of Hope and Innovation	Anaheim	California
United States	Ashland-Bellefonte Cancer Center	Ashland	Kentucky
United States	Rocky Mountain Lions Eye Institute	Aurora	Colorado
United States	University of Colorado Denver CTO/CTRC	Aurora	Colorado
United States	University of Colorado Hospital - Anschutz Inpatient Pavilion	Aurora	Colorado
United States	University of Colorado Hospital - Anschutz Outpatient Pavilion	Aurora	Colorado
United States	University Of Colorado Hospital Cancer Center	Aurora	Colorado
United States	CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center	Bakersfield	California
United States	Maryland Proton Treatment Center	Baltimore	Maryland
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	University of Maryland, Greenebaum Comprehensive Cancer Center	Baltimore	Maryland
United States	Memorial Sloan Kettering Cancer Center-Basking Ridge	Basking Ridge	New Jersey
United States	Lehigh Valley Health Network-Muhlenberg	Bethlehem	Pennsylvania
United States	Beverly Hills Cancer Center	Beverly Hills	California
United States	Tower Hematology Oncology Medical Group	Beverly Hills	California
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Montefiore-Einstein Center for Cancer Care	Bronx	New York
United States	Medical University of South Carolina- Hollings Cancer Center	Charleston	South Carolina
United States	MUSC SCTR Research Nexus Clinical Science Building	Charleston	South Carolina
United States	MUSC- Ashley River Tower	Charleston	South Carolina
United States	MUSC- Radiation Oncology	Charleston	South Carolina
United States	MUSC- Rutledge Tower	Charleston	South Carolina
United States	MUSC- University Hospital	Charleston	South Carolina
United States	DJL Clinical Research, PLLC	Charlotte	North Carolina
United States	Oncology Specialists of Charlotte, PA	Charlotte	North Carolina
United States	UCSD Radiation Oncology South Bay, Cancer Treatment Centers	Chula Vista	California
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	University of Missouri- Ellis Fischel Cancer Center	Columbia	Missouri
United States	Memorial Sloan Kettering Cancer Center Commack	Commack	New York
United States	Sylvester at Coral Gables	Coral Gables	Florida
United States	City of Hope Corona	Corona	California
United States	Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.	Corona	California
United States	Siteman Cancer Center - West County	Creve Coeur	Missouri
United States	Sylvester at Deerfield Beach	Deerfield Beach	Florida
United States	Cypress Hematology & Oncology	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	The Oncology Institute of Hope and Innovation	Downey	California
United States	City of Hope (City of Hope National Medical Center, City of Hope Medical Center)	Duarte	California
United States	GHS Cancer Institute	Easley	South Carolina
United States	Texas Oncology El Paso Cancer Treatment Center	El Paso	Texas
United States	William Beaumont Army Medical Center	El Paso	Texas
United States	William Beaumont Army Medical Center	El Paso	Texas
United States	Karmanos Cancer Institute	Farmington Hills	Michigan
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	Primary Healthcare Associates	Flossmoor	Illinois
United States	University of Texas Medical Branch	Galveston	Texas
United States	The West Clinic, PC dba West Cancer Center	Germantown	Tennessee
United States	Precision Cancer Research / Gettysburg Cancer Center	Gettysburg	Pennsylvania
United States	The Oncology Institute of Hope and Innovation	Glendale	California
United States	GHS Cancer Institute	Greenville	South Carolina
United States	GHS Cancer Institute	Greenville	South Carolina
United States	GHS Cancer Institute	Greer	South Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	PinnacleHealth Cancer Institute	Harrisburg	Pennsylvania
United States	Memorial Sloan Kettering Cancer Center Westchester	Harrison	New York
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Primary Healthcare Associates	Harvey	Illinois
United States	Specialist Global LLC	Hialeah	Florida
United States	Memorial Cancer Institute at Memorial Regional Hospital	Hollywood	Florida
United States	Memorial Hermann Hospital - TMC	Houston	Texas
United States	UTHealth/Memorial Hermann Cancer Center	Houston	Texas
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	UC San Diego Medical Center- La Jolla (Thornton Hospital)	La Jolla	California
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	IU Health Arnett Cancer Center	Lafayette	Indiana
United States	Hollis Cancer Center	Lakeland	Florida
United States	City of Hope Antelope Valley	Lancaster	California
United States	Herbert-Herman Cancer Center, Sparrow Hospital	Lansing	Michigan
United States	UTMB Cancer Center at Victory Lakes	League City	Texas
United States	The Oncology Institute of Hope and Innovation	Long Beach	California
United States	Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute	Los Angeles	California
United States	The Oncology Institute of Hope and Innovation	Los Angeles	California
United States	Norton Brownsboro Hospital	Louisville	Kentucky
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Norton Hospital	Louisville	Kentucky
United States	University Medical Center, Inc.	Louisville	Kentucky
United States	The Oncology Institute of Hope and Innovation	Lynwood	California
United States	PinnacleHealth Cancer Institute	Mechancisburg	Pennsylvania
United States	The West Clinic PC dba West Cancer Center	Memphis	Tennessee
United States	Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Memorial Sloan Kettering Cancer Center- Monmouth	Middletown	New Jersey
United States	The Oncology Institute of Hope and Innovation	Montebello	California
United States	Memorial Sloan Kettering Cancer Center- Bergen	Montvale	New Jersey
United States	Utah Cancer Specialists	Murray	Utah
United States	Henry-Joyce Cancer Clinic	Nashville	Tennessee
United States	Bellevue Hospital Center	New York	New York
United States	Laura and Isaac Perlmutter Cancer Center at NYU Langone	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Cancer Center: Breast and Imaging Center	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	NYU Langone Radiology	New York	New York
United States	NYU Langone Radiology - Ambulatory Care Center East 41st Street	New York	New York
United States	OU Medical Center	Oklahoma City	Oklahoma
United States	Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Sciences Center- Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Department of Radiation Oncology Methodist Hospital	Omaha	Nebraska
United States	Oncology Hematology West, PC dba Nebraska Cancer Specialists	Omaha	Nebraska
United States	UC Irvine Medical Center	Orange	California
United States	Kansas City VA Radiation Oncology Clinic	Overland Park	Kansas
United States	Cypress Hematology and Oncology	Parker	Colorado
United States	Memorial Cancer Institute at Memorial Hospital West	Pembroke Pines	Florida
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	UPMC Shadyside Radiation Oncology	Pittsburgh	Pennsylvania
United States	Sylvester at Plantation	Plantation	Florida
United States	Highlands Cancer Center	Prestonsburg	Kentucky
United States	Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.	Riverside	California
United States	Highlands Oncology Group	Rogers	Arkansas
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Siteman Cancer Center - South County	Saint Louis	Missouri
United States	Washington University School of Medicine Siteman Cancer Center	Saint Louis	Missouri
United States	Siteman Cancer Center- St. Peters	Saint Peters	Missouri
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	UC San Diego Medical Center- Hillcrest	San Diego	California
United States	The Oncology Institute of Hope and Innovation	Santa Ana	California
United States	VA Puget Sound Health Care System	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	GHS Cancer Institute	Seneca	South Carolina
United States	City of Hope South Pasadena	South Pasadena	California
United States	GHS Cancer Institute	Spartanburg	South Carolina
United States	Highlands Oncology Group	Springdale	Arkansas
United States	Stony Brook Cancer Center	Stony Brook	New York
United States	Stony Brook University	Stony Brook	New York
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Primary Healthcare Associates	Tinley Park	Illinois
United States	The Oncology Institute of Hope and Innovation	Torrance	California
United States	Memorial Sloan Kettering Cancer Center- Nassau	Uniondale	New York
United States	The Oncology Institute of Hope and Innovation	West Covina	California
United States	The Oncology Institute of Hope and Innovation	Whittier	California
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  China,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Poland,  Portugal,  Russian Federation,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Number of Participants With Shift From Baseline in Clinical Laboratory Parameters	Grade 1 and 3 ranges are: Anemia:Hb:	Baseline up to 15 months
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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