Study of MK-3475 (Pembrolizumab) in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Treatment With Platinum-based and Cetuximab Therapy (MK-3475-055/KEYNOTE-055)



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:10/3/2015
Start Date:October 2014
End Date:October 2017
Contact:Toll Free Number
Phone:1-888-577-8839

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

A Phase II Clinical Trial of Single Agent Pembrolizumab (MK-3475) in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Who Have Failed Platinum and Cetuximab

This is a study of single-agent pembrolizumab in participants with recurrent and/or
metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed on
platinum-based and cetuximab therapy. The primary study hypothesis is that pembrolizumab
will provide a clinically meaningful objective response rate (ORR).


Inclusion criteria:

- Histologically- or cytologically-confirmed recurrent or metastatic HNSCC of the oral
cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local
therapies

- Tumor progression or recurrence within 6 months of the last dose of any number of
platinum-based and cetuximab therapy lines in the adjuvant, primary, recurrent, or
metastatic setting; must be resistant (not responding) to both platinum and cetuximab

- Available tissue for biomarker analysis

- Measurable disease based on RECIST 1.1 as determined by central review

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Adequate organ function

- Female participants of childbearing potential must have a negative urine or serum
pregnancy test and must be willing to use 2 adequate methods of contraception
starting with the screening visit through 120 days after the last dose of
pembrolizumab

- Male participants with a female partner(s) of childbearing potential must be willing
to use 2 adequate methods of contraception from screening through 120 days after the
last dose of pembrolizumab

Exclusion criteria:

- Disease that is suitable for local therapy administered with curative intent

- Currently receiving treatment in a study of an investigational agent or using an
investigational device <= 4 weeks prior to the first dose of trial medication

- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
of immunosuppressive therapy within 7 days prior to the first dose of trial
medication

- Not recovered from AEs due to a previously administered therapy

- Known additional malignancy that is progressing or requires active treatment
excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin that
has undergone potentially curative therapy or in situ cancer

- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

- Active autoimmune disease requiring systemic treatment within the past 3 months or a
documented history of clinically severe autoimmune disease, or a syndrome that
requires systemic steroids or immunosuppressive agents

- Active, non-infectious pneumonitis

- Active infection requiring systemic therapy

- Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through 120 days
after the last dose of trial medication

- Human immunodeficiency virus (HIV)

- Hepatitis B or C

- Received live vaccine within 30 days of planned start of study therapy
We found this trial at
38
sites
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Allentown, PA
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Chapel Hill, NC
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
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Deerfield Beach, FL
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Easton, PA
Click here to add this to my saved trials
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
?
mi
from
Fargo, ND
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Munster, IN
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
New York, NY
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
415 Curie Boulevard
Philiadelphia, Pennsylvania 19104
?
mi
from
Philiadelphia, PA
Click here to add this to my saved trials
?
mi
from
Plantation, FL
Click here to add this to my saved trials
?
mi
from
Rochester, MN
Click here to add this to my saved trials
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials