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)
NCT02952586
Last updated date
ABOUT THIS STUDY
This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor
activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC
CRT alone in front-line treatment of patients with locally advanced head and neck cancer.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Squamous Cell Carcinoma of the Head and Neck
Sex
Females and Males
Age
18 + years
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Squamous Cell Carcinoma of the Head and NeckStudy 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)
NCT02952586
- Fayetteville, Arkansas
- Rogers, Arkansas
- Springdale, Arkansas
- Anaheim, California
- Bakersfield, California
- Beverly Hills, California
- Beverly Hills, California
- Chula Vista, California
- Corona, California
- Corona, California
- Downey, California
- Duarte, California
- Glendale, California
- La Jolla, California
- La Jolla, California
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- Aurora, Colorado
- Aurora, Colorado
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- Deerfield Beach, Florida
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- Tampa, Florida
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- Prestonsburg, Kentucky
- Baltimore, Maryland
- Baltimore, Maryland
- Baltimore, Maryland
- Boston, Massachusetts
- Detroit, Michigan
- Detroit, Michigan
- Farmington Hills, Michigan
- Lansing, Michigan
- Corinth, Mississippi
- Columbia, Missouri
- Creve Coeur, Missouri
- Kansas City, Missouri
- Saint Louis, Missouri
- Saint Louis, Missouri
- Saint Louis, Missouri
- Saint Peters, Missouri
- Omaha, Nebraska
- Omaha, Nebraska
- Basking Ridge, New Jersey
- Hackensack, New Jersey
- Hackensack, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Albuquerque, New Mexico
- Bronx, New York
- Bronx, New York
- Commack, New York
- Harrison, New York
- New York, New York
- New York, New York
- New York, New York
- New York, New York
- New York, New York
- New York, New York
- New York, New York
- Stony Brook, New York
- Stony Brook, New York
- Uniondale, New York
- Charlotte, North Carolina
- Charlotte, North Carolina
- Winston-Salem, North Carolina
- Cleveland, Ohio
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Allentown, Pennsylvania
- Allentown, Pennsylvania
- Allentown, Pennsylvania
- Bethlehem, Pennsylvania
- Gettysburg, Pennsylvania
- Harrisburg, Pennsylvania
- Mechancisburg, Pennsylvania
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Pittsburgh, Pennsylvania
- Charleston, South Carolina
- Charleston, South Carolina
- Charleston, South Carolina
- Charleston, South Carolina
- Charleston, South Carolina
- Charleston, South Carolina
- Easley, South Carolina
- Greenville, South Carolina
- Greenville, South Carolina
- Greer, South Carolina
- Seneca, South Carolina
- Spartanburg, South Carolina
- Germantown, Tennessee
- Memphis, Tennessee
- Nashville, Tennessee
- El Paso, Texas
- El Paso, Texas
- El Paso, Texas
- Galveston, Texas
- Houston, Texas
- Houston, Texas
- League City, Texas
- Murray, Utah
- Salt Lake City, Utah
- Seattle, Washington
- Seattle, Washington
- Camperdown, New South Wales
- Camperdown, New South Wales
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- St Leonards, New South Wales
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- Geelong, Victoria
- Heidelberg, Victoria
- Linz,
- Brussels,
- Charleroi,
- Haine Saint Paul,
- Namur,
- Wilrijk,
- Quebec,
- Beijing, Beijing
- Fuzhou, Fujian
- Guangzhou, Guangdong
- Guangzhou, Guangdong
- Nanning, Guangxi
- Haikou, Hainan
- Zhengzhou, Henan
- Wuhan, Hubei
- Wuhan, Hubei
- Changsha, Hunan
- Shenyang, Liaoning
- Shanghai, Shanghai
- Shanghai, Shanghai
- Chengdu, Sichuan
- Tianjin, Tianjin
- Haerbin,
- Angers cedex 02,
- Avignon cedex 9,
- Bordeaux CEDEX,
- Bordeaux,
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- Nice cedex 2,
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- Strasbourg,
- Villejuif,
- Berlin, Buch
- Berlin, Buch
- Berlin, Buch
- Berlin, Buch
- Dusseldorf,
- Jena,
- Jena,
- Regensburg,
- Athens, Attica
- Haidari, Attica
- Thessaloniki,
- Budapest,
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- Debrecen,
- Gyor,
- Pecs,
- Szeged,
- Dublin,
- Dublin,
- Dublin,
- Dublin,
- Haifa,
- Jerusalem,
- Petah Tiqva,
- Ramat Gan,
- Brescia, BS
- Meldola, FC
- Meldola, FC
- Cesena, Forlì-cesena
- Meldola, Forlì-cesena
- Lecce, LE
- Modena, MO
- Parma, PR
- Lugo, RA
- Ravenna, RA
- Ravenna, RA
- Legnago, VR
- Napoli,
- Reggio Emilia,
- Nagoya, Aichi
- Nagoya, Aichi
- Kashiwa, Chiba
- Matsuyama, Ehime
- Sapporo, Hokkaido
- Kobe, Hyogo
- Natori, Miyagi
- Sendai, Miyagi
- Osaka-shi, Osaka
- Osakasayama, Osaka
- Kita-adachi-gun, Saitama
- Sunto-gun, Shizuoka
- Shimotsuke, Tochigi
- Chuo-ku, Tokyo
- Koto-ku, Tokyo
- Goyang-si, Gyeonggi-do
- Goyang-si, Gyeonggi-do
- Seongnam-si, Gyeonggi-do
- Seongnam-si, Gyeonggi-do
- Hwasun-gun, Jeollanam-do
- Seoul,
- Seoul,
- Seoul,
- Seoul,
- Seoul,
- Ulsan,
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- Bydgoszcz,
- Gdansk,
- Gliwice,
- Olsztyn,
- Tomaszow Mazowiecki,
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- Matosinhos, Porto
- Senhora da Hora, Porto
- Vila Nova de Gaia, Porto
- Coimbra,
- Porto,
- Porto,
- Porto,
- Porto,
- Chelyabinsk,
- Moscow,
- Omsk,
- Saint-Petersburg,
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- Yaroslavl,
- Badalona, Barcelona
- San Sebastian, Guipuzcoa
- Marbella, Malaga
- El Palmar, Murcia
- Barcelona,
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- Jaen,
- Madrid,
- Madrid,
- Malaga,
- Salamanca,
- Valencia,
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- Basel, Basel-stadt
- Basel, Basel-stadt
- Basel, Basel-stadt
- Bellinzona, Ticino
- Bellinzona, Ticino
- Lausanne, Vaud
- Winterthur, Zuerich
- Winterthur, Zurich
- Winterthur, Zurich
- Zurich,
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- Taipei,
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- Aberdeen,
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- Bristol,
- Edinburgh,
- London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | |||||||
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Brief Title ICMJE | Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100) | ||||||
Official Title ICMJE | 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 | ||||||
Brief Summary | This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE | Squamous Cell Carcinoma of the Head and Neck | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE | 697 | ||||||
Original Estimated Enrollment ICMJE | 640 | ||||||
Actual Study Completion Date ICMJE | June 19, 2020 | ||||||
Actual Primary Completion Date | December 23, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | INCLUSION CRITERIA
EXCLUSION CRITERIA
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | 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, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02952586 | ||||||
Other Study ID Numbers ICMJE | B9991016 2016-001456-21 ( EudraCT Number ) LOCALLY ADVANCED HEAD AND NECK ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | October 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |