Randomized Phase II Trial of Imiquimod with or without 9-Valent HPV Vaccine versus Observation in Patients with High-grade Pre-neoplastic Cervical Lesions (NCT02864147).
Sangini S ShethJi Eun OhStefania BelloneEric Robb SiegelMichelle GreenmanLevent MutluBlair C McNamaraShefali PathyMitchell ClarkMasoud AzodiGary AltwergerVaagn AndikyanGloria Shining HuangElena S RatnerDaniel J KimAkiko IwasakAngelique W LeviNatalia BuzaPei HuiSean FlahertyPeter E SchwartzAlessandro D SantinPublished in: Clinical cancer research : an official journal of the American Association for Cancer Research (2024)
Although imiquimod induced a higher regression to CIN1 or less and significant increases in CD4/CD8 T cells infiltrating the cervix, it did not meet its prespecified statistical outcome for efficacy. A higher regression rate than expected was observed in the surveillance arm of this prospective trial. Future clinical trials with imiquimod targeting CIN3 patients are warranted.