The purpose of this research study is to find out what effects, good and/or bad, topical
application of the drug Aldara will have on patients and on their oral cancer. Aldara is a
drug that activates toll-like receptor (TLR) in oral cancer cells causing self-destruction of
tumor cells. It also activates immune cells to attack and eliminate cancer cells. Aldara is
currently approved by the Food and Drug Administration (FDA) for treatment of skin cancer and
melanoma. Its use in this study is 'off-label' (use of a drug approved by FDA for skin cancer
to treat oral cancer in this study).
To assess the preliminary efficacy of topical imiquimod in neoadjuvant setting in patients
with early-stage oral squamous cell carcinoma as determined by best response rate (CR and
PR). To assess local and systemic safety and tolerability by CTCAE v5 criteria. To explore
the effect of imiquimod on the tumor immune microenvironment by performing quantitative
multiplex immunofluorescence.