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)
Launched by PFIZER · Oct 31, 2016
Trial Information
Current as of June 02, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • 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).
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bronx, New York, United States
Tampa, Florida, United States
Philadelphia, Pennsylvania, United States
Saint Louis, Missouri, United States
Harvey, Illinois, United States
Detroit, Michigan, United States
Hackensack, New Jersey, United States
New York, New York, United States
Neuilly Sur Seine, , France
Hollywood, Florida, United States
Madrid, , Spain
Zaragoza, , Spain
Boston, Massachusetts, United States
Barcelona, , Spain
New York, New York, United States
Seattle, Washington, United States
Sapporo, Hokkaido, Japan
Seattle, Washington, United States
Galveston, Texas, United States
Baltimore, Maryland, United States
Pittsburgh, Pennsylvania, United States
Taipei, , Taiwan
Hackensack, New Jersey, United States
Salt Lake City, Utah, United States
Madrid, , Spain
Miami, Florida, United States
Detroit, Michigan, United States
Salamanca, , Spain
Zurich, , Switzerland
New York, New York, United States
Oklahoma City, Oklahoma, United States
Fayetteville, Arkansas, United States
Louisville, Kentucky, United States
Beverly Hills, California, United States
Nice Cedex 2, , France
La Jolla, California, United States
Madrid, , Spain
Heidelberg, Victoria, Australia
Kansas City, Missouri, United States
Barcelona, , Spain
Taipei, , Taiwan
Kashiwa, Chiba, Japan
Sendai, Miyagi, Japan
Malaga, , Spain
Lausanne, Vaud, Switzerland
Cordoba, , Spain
Taichung, , Taiwan
Villejuif, , France
Salamanca, , Spain
Chuo Ku, Tokyo, Japan
Louisville, Kentucky, United States
Taichung, , Taiwan
Seoul, , Korea, Republic Of
New York, New York, United States
Tainan, , Taiwan
South Pasadena, California, United States
Kobe, Hyogo, Japan
New York, New York, United States
Albuquerque, New Mexico, United States
Regensburg, , Germany
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Lancaster, California, United States
Jaen, , Spain
Sunto Gun, Shizuoka, Japan
Charlotte, North Carolina, United States
Paris, , France
Tianjin, Tianjin, China
Aurora, Colorado, United States
Guangzhou, Guangdong, China
Barcelona, , Spain
Nagoya, Aichi, Japan
Gdansk, , Poland
Chengdu, Sichuan, China
New York, New York, United States
Nashville, Tennessee, United States
Nagoya, Aichi, Japan
Osakasayama, Osaka, Japan
Lafayette, Indiana, United States
Winston Salem, North Carolina, United States
Budapest, , Hungary
League City, Texas, United States
Natori, Miyagi, Japan
London, , United Kingdom
Matsuyama, Ehime, Japan
Cleveland, Ohio, United States
Dusseldorf, , Germany
Bakersfield, California, United States
Downey, California, United States
Saint Louis, Missouri, United States
Pittsburgh, Pennsylvania, United States
Camperdown, New South Wales, Australia
Ashland, Kentucky, United States
Brussels, , Belgium
El Paso, Texas, United States
Thessaloniki, , Greece
Marbella, Malaga, Spain
Commack, New York, United States
Beverly Hills, California, United States
Valencia, , Spain
Shanghai, Shanghai, China
Lansing, Michigan, United States
Koto Ku, Tokyo, Japan
Rogers, Arkansas, United States
Zhengzhou, Henan, China
Aurora, Colorado, United States
Creve Coeur, Missouri, United States
Oklahoma City, Oklahoma, United States
Harbin, Heilongjiang, China
Neuilly Sur Seine, , France
Beijing, Beijing, China
Jena, , Germany
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Baltimore, Maryland, United States
Wuhan, Hubei, China
Springdale, Arkansas, United States
Louisville, Kentucky, United States
Parma, Pr, Italy
Corona, California, United States
Bronx, New York, United States
Debrecen, , Hungary
Haifa, , Israel
Shimotsuke, Tochigi, Japan
Basking Ridge, New Jersey, United States
Orange, California, United States
Louisville, Kentucky, United States
Wuhan, Hubei, China
Saint Louis, Missouri, United States
Kita Adachi Gun, Saitama, Japan
Porto, , Portugal
Deerfield Beach, Florida, United States
Pembroke Pines, Florida, United States
Stony Brook, New York, United States
Seoul, , Korea, Republic Of
Avignon Cedex 9, , France
Farmington Hills, Michigan, United States
San Sebastian, Guipuzcoa, Spain
Harrison, New York, United States
Petah Tiqva, , Israel
Baltimore, Maryland, United States
Bordeaux, , France
Plantation, Florida, United States
Geelong, Victoria, Australia
Ulsan, , Korea, Republic Of
Taipei, , Taiwan
Quebec, , Canada
Winterthur, Zurich, Switzerland
Napoli, , Italy
El Palmar, Murcia, Spain
Aberdeen, , United Kingdom
Easley, South Carolina, United States
Greenville, South Carolina, United States
Greer, South Carolina, United States
Seneca, South Carolina, United States
Spartanburg, South Carolina, United States
Murray, Utah, United States
Kashiwa, Chiba, Japan
Anaheim, California, United States
Glendale, California, United States
Long Beach, California, United States
Lynwood, California, United States
Montebello, California, United States
Santa Ana, California, United States
Whittier, California, United States
San Diego, California, United States
Shenyang, Liaoning, China
Hwasun Gun, Jeollanam Do, Korea, Republic Of
Harrisburg, Pennsylvania, United States
Duarte, California, United States
Girona, , Spain
Szeged, , Hungary
Louisville, Kentucky, United States
Basel, Basel Stadt, Switzerland
Brescia, Bs, Italy
Montvale, New Jersey, United States
Middletown, New Jersey, United States
Stony Brook, New York, United States
Stony Brook, New York, United States
Lakeland, Florida, United States
Debrecen, , Hungary
Chengdu, Sichuan, China
Dublin, , Ireland
Taipei, Beitou District, Taiwan
Taipei, Zhongzheng District, Taiwan
Dublin, , Ireland
Chula Vista, California, United States
Corona, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Riverside, California, United States
Torrance, California, United States
West Covina, California, United States
Aurora, Colorado, United States
Aurora, Colorado, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Parker, Colorado, United States
Coral Gables, Florida, United States
Hialeah, Florida, United States
Flossmoor, Illinois, United States
Harvey, Illinois, United States
Tinley Park, Illinois, United States
Overland Park, Kansas, United States
Prestonsburg, Kentucky, United States
Columbia, Missouri, United States
Saint Peters, Missouri, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
New York, New York, United States
New York, New York, United States
Uniondale, New York, United States
Charlotte, North Carolina, United States
Oklahoma City, Oklahoma, United States
Allentown, Pennsylvania, United States
Allentown, Pennsylvania, United States
Allentown, Pennsylvania, United States
Bethlehem, Pennsylvania, United States
Gettysburg, Pennsylvania, United States
Mechancisburg, Pennsylvania, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Germantown, Tennessee, United States
Memphis, Tennessee, United States
El Paso, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Camperdown, New South Wales, Australia
Camperdown, New South Wales, Australia
St Leonards, New South Wales, Australia
Wollongong, New South Wales, Australia
Linz, , Austria
Charleroi, , Belgium
Haine Saint Paul, , Belgium
Namur, , Belgium
Wilrijk, , Belgium
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Nanning, Guangxi, China
Haikou, Hainan, China
Changsha, Hunan, China
Shanghai, Shanghai, China
Angers Cedex 02, , France
Bordeaux, , France
Brest, , France
Brest, , France
Levallois Perret, , France
Montpellier Cedex 5, , France
Nantes Cedex 2, , France
Nantes Cedex 2, , France
Saint Gregoire, , France
Saint Herblain Cedex, , France
Saint Priest En Jarez Cedex, , France
Strasbourg Cedex, , France
Strasbourg, , France
Berlin, Buch, Germany
Berlin, Buch, Germany
Berlin, Buch, Germany
Berlin, Buch, Germany
Athens, Attica, Greece
Haidari, Attica, Greece
Budapest, , Hungary
Budapest, , Hungary
Gyor, , Hungary
Pecs, , Hungary
Dublin, , Ireland
Dublin, , Ireland
Jerusalem, , Israel
Ramat Gan, , Israel
Meldola, Fc, Italy
Meldola, Fc, Italy
Cesena, Forlì Cesena, Italy
Meldola, Forlì Cesena, Italy
Lecce, Le, Italy
Modena, Mo, Italy
Lugo, Ra, Italy
Ravenna, Ra, Italy
Ravenna, Ra, Italy
Legnago, Vr, Italy
Reggio Emilia, , Italy
Osaka Shi, Osaka, Japan
Goyang Si, Gyeonggi Do, Korea, Republic Of
Goyang Si, Gyeonggi Do, Korea, Republic Of
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Ulsan, , Korea, Republic Of
Bydgoszcz, , Poland
Gliwice, , Poland
Olsztyn, , Poland
Tomaszow Mazowiecki, , Poland
Tomaszow Mazowiecki, , Poland
Matosinhos, Porto, Portugal
Senhora Da Hora, Porto, Portugal
Vila Nova De Gaia, Porto, Portugal
Coimbra, , Portugal
Porto, , Portugal
Porto, , Portugal
Porto, , Portugal
Chelyabinsk, , Russian Federation
Moscow, , Russian Federation
Omsk, , Russian Federation
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Yaroslavl, , Russian Federation
Badalona, Barcelona, Spain
Basel, Basel Stadt, Switzerland
Basel, Basel Stadt, Switzerland
Bellinzona, Ticino, Switzerland
Bellinzona, Ticino, Switzerland
Winterthur, Zuerich, Switzerland
Winterthur, Zurich, Switzerland
Zurich, , Switzerland
Zurich, , Switzerland
Taoyuan City, , Taiwan
Bebington, , United Kingdom
Bristol, , United Kingdom
Edinburgh, , United Kingdom
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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