This research study is studying immunotherapy in combination with radiation therapy as a
possible treatment for head & neck cancer that has worsened or spread to another organ or
part of your body.
The immunotherapy involved in this study is: MK-3475 (pembrolizumab or KEYTRUDA).
This research study is a Phase II clinical trial. Phase II clinical trials test the safety
and effectiveness of an investigational treatment to learn whether the treatment works in
treating a specific disease. "Investigational" means that the treatment is being studied.
MK-3475 is a humanized monoclonal antibody. An antibody is a common type of protein made in
the body in response to a foreign substance (particles not typically found in the body such
as bacteria or viruses). Antibodies attack foreign substances and protect against infection.
Antibodies can also be produced in the laboratory for use in treating patients. MK-3475 is
designed to restore the natural ability of the immune system to recognize and target cancer
The FDA recently granted approval to MK-3475 as a treatment for patients with recurrent or
metastatic head and neck squamous cell carcinoma (HNSCC). This study is testing whether using
radiation in combination with MK-3475 will make this drug work better in participants that
might otherwise be unlikely to benefit from this drug because they have not responded to
either this same drug given without radiation or another similar drug.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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