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)



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/20/2019
Start Date:November 28, 2016
End Date:May 18, 2022
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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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.


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).
We found this trial at
128
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
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1150 N 35th Ave # 330
Hollywood, Florida 33021
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1660 South Columbian Way
Seattle, Washington 98108
(206) 762-1010
VA Puget Sound Health Care System With a reputation for excellence, innovation and extraordinary care...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1200 South Cedar Crest Boulevard
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
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1240 South Cedar Crest Boulevard
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Ashland, Kentucky 41101
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Baltimore, Maryland 21201
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655 West Baltimore Street
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(410) 706-7410
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22 South Greene Street
Baltimore, Maryland 21201
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136 Mountainview Blvd
Basking Ridge, New Jersey 7920
(908) 542-3000
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2545 Schoenersville Road
Bethlehem, Pennsylvania 18017
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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119-143 Missenden Road
Camperdown, New South Wales 2050
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135 Rutledge Avenue
Charleston, South Carolina 29403
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Charleston, South Carolina 29401
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96 Jonathan Lucas Street
Charleston, South Carolina 29425
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169 Ashley Avenue
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650 Commack Rd
Commack, New York 11725
(631) 623-4000
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Corinth, Mississippi 38834
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340 Medical Parkway
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30 Prospect Ave
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92 2nd St
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
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71 Ald Taylor Way
Harvey, Illinois 60426
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Hialeah, Florida 33012
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Kansas City, Missouri 64128
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3855 Health Sciences Dr,
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529 S Jackson St
Louisville, Kentucky 40202
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2035 Technology Parkway
Mechancisburg, Pennsylvania 17050
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5555 Ponce De Leon Boulevard
Miami, Florida 33146
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1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
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480 Red Hill Road
Middletown, New Jersey 07748
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Murray, Utah 84157
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1275 York Ave
New York, New York 10021
(212) 639-2000
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