Cervical dysplasia Trials in Disease

Study on Pembrolizumab for Patients with High-Grade HPV-Related Vulvar and Cervical Lesions

This clinical trial is investigating pembrolizumab (also known by its brand name KEYTRUDA) as a potential treatment for high-grade pre-cancerous lesions caused by human papillomavirus (HPV) infection. The study focuses on cervical high-grade squamous intraepithelial lesions (HSIL) and vulvar intraepithelial neoplasia (VIN) 2-3, both of which are abnormal cell changes that can potentially progress to cancer if left untreated.

Who can participate:

• Female participants who are at least 18 years old
• Confirmed diagnosis of cervical HSIL or vulvar VIN 2-3 lesions through biopsy
• Not pregnant or breastfeeding, with agreement to use contraception during the study and for three months after the last treatment
• Able to provide written consent to participate
• Able to provide a tissue sample from a biopsy (either previous or new) in a specific preserved form
• Performance status of 0 to 1 on the ECOG scale, meaning they are fully active or only restricted in physically demanding activities but able to carry out light work
• Adequate organ function confirmed through laboratory tests

Who cannot participate:

• Male patients
• Patients without high-grade HPV-related vulvar or cervical lesions
• Patients who are part of vulnerable populations with limited ability to protect their own interests

Study focus and goals:

The main goal of this trial is to determine how effective pembrolizumab is in causing complete regression of the abnormal cervical and vulvar lesions. Complete regression means that the lesions disappear or reduce significantly, which could prevent them from developing into cancer. The study will also track whether HPV is still detectable after treatment, with a specific evaluation planned at the 36-week visit.

All participants will receive the same treatment in this single-arm study, which means there is no comparison group receiving a different medication or placebo. The treatment involves intravenous infusions of pembrolizumab, meaning the medication is delivered directly into a vein. The treatment period is expected to last up to six months, and participants will be closely monitored for changes in their lesions and any side effects throughout this period.

Investigational drug:

Pembrolizumab is an immune checkpoint inhibitor that works by blocking the PD-1 pathway. This helps the immune system recognize and attack abnormal cells more effectively. The medication is administered as an intravenous infusion using KEYTRUDA 25 mg/mL concentrate. In this study, pembrolizumab is being tested to see whether it can help the body's immune system eliminate pre-cancerous lesions caused by HPV, potentially offering an alternative to immediate surgical treatment.

The study is expected to conclude by January 31, 2026, and will provide valuable information about whether pembrolizumab could become a new treatment option for patients with these specific HPV-related conditions.