Phase 2 Study of HPV Vaccine Combined With Imiquimod and Metformin for Cervical, Vaginal, and Vulvar Cancer Treatment

What this Trial Is About

Researchers are investigating whether adding certain treatments can help boost the immune system to better fight cancer caused by the Human Papillomavirus HPV, which spreads through intimate skin contact. This trial focuses on patients with locally advanced cervical, vaginal, or vulvar cancers. It aims to find out if combining these new treatments with standard therapies improves the time patients remain free from cancer progression over 24 months, while also monitoring safety and immune system responses. Participants will receive intratumoral HPV vaccinations during their 2nd and 4th weeks of radiation, then again at weeks 8, 10, 12, and 16 after radiation ends. During each visit, blood samples and tumor cells will be collected, and imiquimod cream will be applied. Participants will take metformin pills twice daily for two weeks and apply imiquimod suppositories three times a week at home. Follow-up PETCT scans and clinical exams will monitor treatment effects over two years. Throughout the study, immune system markers such as CD4, CD8, NK cells, and HPV viral load will be measured at key points. Researchers will track side effects, immune changes, and progression-free survival. Participants will have regular exams every three months for two years to evaluate their health and treatment response, with the total participation lasting up to two years.

HPV Vaccine, Imiquimod, and Metformin Combination Trial