A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048)



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:12/9/2016
Start Date:March 2015
End Date:September 2018
Contact:Toll Free Number
Phone:1-888-577-8839

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

A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Participants with recurrent or metastatic (R/M) squamous cell cancer of the head and neck
(HNSCC) will be randomly assigned to receive pembrolizumab alone, or pembrolizumab + a
platinum-based drug (cisplatin or carboplatin) + 5-Fluorouracil (5-FU), or cetuximab + a
platinum-based drug (cisplatin or carboplatin) + 5-FU. The primary study hypothesis is that
pembrolizumab or pembrolizumab in combination with chemotherapy prolongs progression free
survival and overall survival compared to standard treatment.


Inclusion Criteria:

- Histologically- or cytologically-confirmed recurrent or metastatic head and neck
squamous cell carcinoma considered incurable by local therapies

- No prior systemic therapy administered in the recurrent or metastatic setting (with
the exception of systemic therapy completed > 6 months prior if given as part of
multimodal treatment for locally advanced disease)

- Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx.
Participants may not have a primary tumor site of nasopharynx (any histology)

- Measurable disease

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

- Adequate organ function

- Can provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy
(fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days
prior to start of study treatment) is preferred but an archival sample is acceptable.

- Have results from testing of HPV status for oropharyngeal cancer

- Female participants of childbearing potential should have a negative pregnancy test
and must be willing to use 2 methods of birth control or be surgically sterile, or
abstain from heterosexual activity for the course of the study through 180 days after
the last dose of study medication

- Male participants must agree to use an adequate method of contraception starting with
the first dose of study medication through 180 days after the last dose of study
medication

Exclusion Criteria:

- Disease suitable for local therapy administered with curative intent

- Has progressive disease (PD) within six (6) months of completion of curatively
intended systemic treatment for locoregionally advanced HNSCC

- Radiation therapy (or other non-systemic therapy) within 2 weeks prior to
randomization or not fully recovered from adverse events due to a previously
administered treatment

- Currently participating and receiving study therapy, or participated in a study of an
investigational agent and received study therapy, or used an investigational device
within 4 weeks of the first dose of study medication

- Life expectancy of <3 months and/or has rapidly progressing disease

- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
of immunosuppressive therapy within 7 days prior to the first dose of study
medication (physiologic doses of corticosteroids may be approved after consultation
with the Sponsor)

- Diagnosed and/or treated additional malignancy within 5 years prior to randomization
with the exception of curatively treated basal cell carcinoma of the skin, squamous
cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast
cancers

- Has had an allogeneic tissue/solid organ transplant

- Active central nervous system metastases and/or carcinomatous meningitis

- Active autoimmune disease that has required systemic treatment in past 2 years;
replacement therapy is not considered a form of systemic treatment

- History of (non-infectious) pneumonitis that required steroids or current pneumonitis

- Active infection requiring systemic therapy

- Known psychiatric or substance abuse disorders that would interfere with cooperation
with the requirements of the trial

- Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through 180 days
after the last dose of study medication

- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or previously
participated in Merck MK-3475 clinical trial

- Known history of human immunodeficiency virus (HIV)

- Known active Hepatitis B or C

- Received a live vaccine within 30 days of planned start of study medication
We found this trial at
59
sites
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Allentown, PA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Buenos Aires,
Phone: 54 11 4796 8200
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Danbury, CT
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Duluth, MN
Click here to add this to my saved trials
?
mi
from
Easton, PA
Click here to add this to my saved trials
?
mi
from
Evanston, IL
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
Farmington, CT
Click here to add this to my saved trials
?
mi
from
Goshen, IN
Click here to add this to my saved trials
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
?
mi
from
Jackson, MS
Click here to add this to my saved trials
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
?
mi
from
Lansing, MI
Click here to add this to my saved trials
?
mi
from
Livingston, NJ
Click here to add this to my saved trials
?
mi
from
Lone Tree, CO
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Marietta, GA
Click here to add this to my saved trials
?
mi
from
Marshfield, WI
Click here to add this to my saved trials
?
mi
from
McAllen, TX
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
New Haven, CT
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
Niles, IL
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
?
mi
from
Roslyn, NY
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
Seattle, WA
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
St. Louis Park, Minnesota 55426
?
mi
from
St. Louis Park, MN
Click here to add this to my saved trials
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
?
mi
from
Tyler, TX
Click here to add this to my saved trials
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
?
mi
from
Westwood, KS
Click here to add this to my saved trials