The purpose of this study is to evaluate anti-PD-1 Neoadjuvant therapy in Basal cell
carcinoma to provide a better outcome when administered prior to surgery and provide a
therapeutic strategy to avoid surgery altogether. The study team will gather information
about how Basal cell carcinoma responds to Pembrolizumab prior to surgery and to gather
information about recurrence rates.
Pembrolizumab, is an investigational (experimental) drug that may improve the response of the
immune system against cancer. Pembrolizumab is a manufactured antibody, much like the
antibodies usually made by the human body to fight off infection. The idea behind developing
this experimental drug is to stimulate the body's immune system to kill cancer cells.
Pembrolizumab antibody has been specifically made to block a program cell death-1 (PD-1)
protein receptor, which is found on cells of the immune system. PD-1 receptor seems to slow
down the immune response. Blocking PD-1 with pembrolizumab antibody may make the immune
response more active and may improve the response of the immune system against cancer.
Pembrolizumab is currently FDA approved for use in other malignancies. It has been used to
treat a number of other diseases such as certain types of lung cancer, cervical cancer and
lymphoma. The use of Pembrolizumab in this study is experimental because it is not approved
by the Food and Drug Administration (FDA) for use in the treatment of Basal cell carcinoma.
This is a phase 1 study looking at anti-PD-1 Neoadjuvant therapy in Basal cell carcinoma in
participants with locoregionally advanced, but resectable basal cell carcinoma of the head
and neck. Participants will undergo fine cut CT imaging (head and neck) and treatment with
the study drug pembrolizumab.
The primary objective of this study is to evaluate pathologic response to pre-operative
treatment of pembrolizumab in the study group.
Secondary objectives of this study include assessing safety of the intervention, and
assessing phenotyping immune infiltrates in non-pathology complete responders (pCRs), as well
as assessment of changes to the systemic immune system (e.g. peripheral blood lymphocytes
(PBLs)) in pCRs vs partial responders (pPR) vs non responders.
The exploratory objective will include assessing one-year recurrence rates after completion
of NeoAdjuvant-Adjuvant therapy.
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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