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 |
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.
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
sites
8100 Southwest 10th Street
Plantation, Florida 33324
Plantation, Florida 33324
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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1150 N 35th Ave # 330
Hollywood, Florida 33021
Hollywood, Florida 33021
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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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
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
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18103
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655 West Baltimore Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 706-7410
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
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136 Mountainview Blvd
Basking Ridge, New Jersey 7920
Basking Ridge, New Jersey 7920
(908) 542-3000
Memorial Sloan-Kettering Cancer Center - Basking Ridge At Memorial Sloan Kettering Basking Ridge, we offer...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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650 Commack Rd
Commack, New York 11725
Commack, New York 11725
(631) 623-4000
Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
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Corona, California 92879
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Deerfield Beach, Florida 33442
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
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Fountain Valley, California 92708
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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92 2nd St
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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3855 Health Sciences Dr,
La Jolla, California 92093
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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Los Angeles, California 90048
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James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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5555 Ponce De Leon Boulevard
Miami, Florida 33146
Miami, Florida 33146
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1475 NW 12th Ave
Miami, Florida 33136
Miami, Florida 33136
(305) 243-1000
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Oklahoma City, Oklahoma 73104
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