Phase II Study of Pembrolizumab Treatment for Women With High-Grade Cervical Intraepithelial Neoplasia

What this Trial Is About

Researchers are evaluating pembrolizumab, an immunotherapy drug, for treating cervical intraepithelial neoplasia CIN, a precancerous condition of the cervix. This phase II trial aims to study the safety and effectiveness of pembrolizumab in helping the bodys immune system fight abnormal cell growth in high-grade CIN, including carcinoma in situ without invasive cancer. The study also explores biomarkers like PD-L1 expression and HPV status to understand responses to the treatment. Participants receive pembrolizumab administered intravenously over 30 minutes on day 1, repeating every 6 weeks for a total of 4 cycles lasting 24 weeks. The treatment phase is followed by assessments including a biopsy after the second cycle and a surgical procedure such as loop electrode excision or cold-knife cone at the end of treatment, unless surgery is contraindicated. The study is open-label and single-arm, focusing solely on pembrolizumab without a comparison group. During the study, participants undergo multiple evaluations including pathological assessments to measure complete or partial responses of the cervical lesions at 6 months. Safety and tolerability are closely monitored through adverse event tracking. Participants must provide tissue samples before and during the study, and their health status, organ functions, and pregnancy status are regularly assessed. The total participation duration covers the 24 weeks of treatment with follow-up evaluations up to 6 months to observe treatment outcomes and side effects.

Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia