Neoadjuvant Imiquimod Immunotherapy for Oral Cancer

Summary

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). The preliminary efficacy of topical imiquimod in a neoadjuvant setting in patients with early-stage oral squamous cell carcinoma will be determined by a reduction in tumor cellularity in post-treatment tissue compared to pre-treatment tissue. Safety and tolerability will be evaluated by CTCAE v5 criteria. The effect of imiquimod on the tumor immune microenvironment will be assessed by performing quantitative multiplex immunofluorescence.

Timeline

Start

2022-04-28

Primary completion

2023-06-30

Completion

2024-07-31

Publications

• Yoon AJ, Carvajal RD, Graboyes EM, Kaczmar JM, Albergotti WG, Kejner AE, Troob SH, Philipone E, Anoma JS, Armeson KE, Hill EG, Richardson MS, Woods TR, Chera BS, Nourollah-Zadeh F, Lee BJ, Pandruvada S, Kourtidis A, Kingsley C, O'Quinn EC, Mills S, Jordan VC, Spencer M, Fails D, McKee TD, Zaidi M, Brisendine A, Horn S, Mehrotra S, Ogretmen B, Newman JG. Pilot clinical trial of neoadjuvant toll-like receptor 7 agonist (Imiquimod) immunotherapy in early-stage oral squamous cell carcinoma. Front Immunol. 2025 Jan 27;16:1530262. doi: 10.3389/fimmu.2025.1530262. eCollection 2025.

Drugs

Indications