HPV Vaccine, Imiquimod, and Metformin Combination Trial

Summary

The goal of this clinical trial is to explore whether additional treatments can help strengthen the participant's immune system to fight cancer caused by the Human Papillomavirus (HPV), a virus spread through intimate skin-to-skin contact. The trial will also monitor the safety of these treatments. The main questions it aims to answer are: Does the combination of treatments help the participant's body fight the cancer more effectively when used alongside standard therapy? What side effects or medical issues arise when using these experimental treatments? Researchers will use three experimental therapies along with the participant's standard treatment to find out if these therapies work better together than standard treatment alone. Participants will: Receive HPV vaccinations during the 2nd and 4th week of radiation, and again at weeks 8, 10, 12, and 16 after completing radiation. Have blood samples taken, tumor cells brushed from the surface, and imiquimod cream applied during each visit. Take a daily metformin pill and apply an imiquimod suppository three times a week for two weeks after each visit.

Timeline

Start

2024-08-23

Primary completion

2026-08-23

Completion

2028-08-23

Publications

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• Background Soliman H, Hogue D, Han H, Mooney B, Costa R, Lee MC, Niell B, Williams A, Chau A, Falcon S, Soyano A, Armaghani A, Khakpour N, Weinfurtner RJ, Hoover S, Kiluk J, Laronga C, Rosa M, Khong H, Czerniecki B. Oncolytic T-VEC virotherapy plus neoadjuvant chemotherapy in nonmetastatic triple-negative breast cancer: a phase 2 trial. Nat Med. 2023 Feb;29(2):450-457. doi: 10.1038/s41591-023-02210-0. Epub 2023 Feb 9.
• Background Margalit O, Lieberman S, Redinsky I, Halparin S, Honig N, Raskin S, Ben-Ayun M, Shacham-Shmueli E, Halpern N, Urban D, Ackerstein A, Shulman K, Ben-Ami E, Semenisty V, Purim O, Yarom N, Golan T, Boursi B, Appel S, Symon Z, Berger R, Mauro D, Krieg AM, Lawrence YR. Combination Treatment of Intratumoral Vidutolimod, Radiosurgery, Nivolumab, and Ipilimumab for Microsatellite Stable Colorectal Carcinoma With Liver Metastases. Clin Colorectal Cancer. 2023 Dec;22(4):442-449.e1. doi: 10.1016/j.clcc.2023.08.004. Epub 2023 Aug 9.
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Indications