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

Use our guide to learn which trials are right for you!

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
sites
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
?
mi
from
Galveston, TX
Click here to add this to my saved trials
1150 N 35th Ave # 330
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
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...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
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...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
1200 South Cedar Crest Boulevard
Allentown, Pennsylvania 18103
?
mi
from
Allentown, PA
Click here to add this to my saved trials
1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
?
mi
from
Allentown, PA
Click here to add this to my saved trials
1240 South Cedar Crest Boulevard
Allentown, Pennsylvania 18103
?
mi
from
Allentown, PA
Click here to add this to my saved trials
Ashland, Kentucky 41101
?
mi
from
Ashland, KY
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
12605 East 16th Avenue
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Baltimore, Maryland 21201
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
22 South Greene Street
Baltimore, Maryland 21201
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
136 Mountainview Blvd
Basking Ridge, New Jersey 7920
(908) 542-3000
Memorial Sloan-Kettering Cancer Center - Basking Ridge At Memorial Sloan Kettering Basking Ridge, we offer...
?
mi
from
Basking Ridge, NJ
Click here to add this to my saved trials
2545 Schoenersville Road
Bethlehem, Pennsylvania 18017
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
119-143 Missenden Road
Camperdown, New South Wales 2050
?
mi
from
Camperdown,
Click here to add this to my saved trials
135 Rutledge Avenue
Charleston, South Carolina 29403
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charleston, South Carolina 29401
?
mi
from
Charleston, SC
Click here to add this to my saved trials
96 Jonathan Lucas Street
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
169 Ashley Avenue
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28210
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Columbia, MO
Click here to add this to my saved trials
650 Commack Rd
Commack, New York 11725
(631) 623-4000
Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
?
mi
from
Commack, NY
Click here to add this to my saved trials
Corinth, Mississippi 38834
?
mi
from
Corinth, MS
Click here to add this to my saved trials
Corona, California 92879
?
mi
from
Corona, CA
Click here to add this to my saved trials
?
mi
from
Corona, CA
Click here to add this to my saved trials
Creve Coeur, Missouri 63141
?
mi
from
Creve Coeur, MO
Click here to add this to my saved trials
?
mi
from
Deerfield Beach, FL
Click here to add this to my saved trials
2555 South Downing Street
Denver, Colorado 80210
?
mi
from
Denver, CO
Click here to add this to my saved trials
Denver, Colorado 80210
?
mi
from
Denver, CO
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Duarte, CA
Click here to add this to my saved trials
?
mi
from
Duarte, CA
Click here to add this to my saved trials
109 Fleetwood Drive
Easley, South Carolina 29640
?
mi
from
Easley, SC
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
?
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
Fayetteville, Arkansas 72703
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
19550 Governors Hwy # 2300
Flossmoor, Illinois 60422
?
mi
from
Flossmoor, IL
Click here to add this to my saved trials
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Galveston, Texas 77555
?
mi
from
Galveston, TX
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
?
mi
from
Gettysburg, PA
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
340 Medical Parkway
Greer, South Carolina 29651
?
mi
from
Greer, SC
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
111 South Front Street
Harrisburg, Pennsylvania 17101
?
mi
from
Harrisburg, PA
Click here to add this to my saved trials
Harrisburg, Pennsylvania 17109
?
mi
from
Harrisburg, PA
Click here to add this to my saved trials
500 Westchester Avenue
Harrison, New York 10604
?
mi
from
Harrison, NY
Click here to add this to my saved trials
1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
?
mi
from
Harvey, IL
Click here to add this to my saved trials
71 Ald Taylor Way
Harvey, Illinois 60426
?
mi
from
Harvey, IL
Click here to add this to my saved trials
Hialeah, Florida 33012
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
3501 Johnson Street
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Kansas City, Missouri 64128
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lafayette, Indiana 47904
?
mi
from
Lafayette, IN
Click here to add this to my saved trials
Lakeland, Florida 33805
?
mi
from
Lakeland, FL
Click here to add this to my saved trials
44151 15th Street West
Lancaster, California 93534
?
mi
from
Lancaster, CA
Click here to add this to my saved trials
?
mi
from
Lansing, MI
Click here to add this to my saved trials
League City, Texas 77573
?
mi
from
League City, TX
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
529 S Jackson St
Louisville, Kentucky 40202
(502) 562-4369
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Louisville, Kentucky 40207
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
2035 Technology Parkway
Mechancisburg, Pennsylvania 17050
?
mi
from
Mechancisburg, PA
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
5555 Ponce De Leon Boulevard
Miami, Florida 33146
?
mi
from
Miami, FL
Click here to add this to my saved trials
1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
?
mi
from
Miami, FL
Click here to add this to my saved trials
480 Red Hill Road
Middletown, New Jersey 07748
?
mi
from
Middletown, NJ
Click here to add this to my saved trials
Murray, Utah 84157
?
mi
from
Murray, UT
Click here to add this to my saved trials
Nashville, Tennessee 37232
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Nashville, Tennessee 37232
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials