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.
Keyphrases
- high grade
- clinical trial
- phase iii
- phase ii
- open label
- end stage renal disease
- ejection fraction
- double blind
- low grade
- chronic kidney disease
- placebo controlled
- newly diagnosed
- public health
- study protocol
- peritoneal dialysis
- preterm birth
- randomized controlled trial
- high glucose
- cancer therapy
- patient reported outcomes
- drug delivery
- drug induced
- diabetic rats
- current status