Vulvar dysplasia Trials in Disease

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

This clinical trial is investigating whether pembrolizumab, an immunotherapy medication, can help treat high-grade pre-cancerous lesions caused by human papillomavirus (HPV) infection in the vulva and cervix. These lesions, known as vulvar intraepithelial neoplasia (VIN) 2-3 and cervical high-grade squamous intraepithelial lesions (HSIL), have the potential to develop into cancer if left untreated.

Main inclusion criteria:

• Female participants aged 18 years or older
• Confirmed diagnosis of cervical HSIL or vulvar VIN 2-3 lesions
• Not pregnant or breastfeeding, with agreement to use contraception during treatment and for 3 months afterwards
• Ability to provide written informed consent
• Availability of tissue sample from a biopsy for study purposes
• Good general health status, with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, meaning participants can carry out normal daily activities or are restricted only in physically demanding activities
• Adequate organ function confirmed through laboratory tests within 10 days before starting treatment

Main exclusion criteria:

• Male participants
• Absence of high-grade HPV-related vulvar or cervical lesions
• Participants considered part of a vulnerable population who may have limited ability to protect their own interests

Focus and goal of the trial:

The study aims to determine how effective pembrolizumab is in causing complete regression of high-grade pre-cancerous lesions, meaning the abnormal cells disappear or reduce significantly. The treatment is designed to help prevent these lesions from progressing to invasive cancer. Participants will receive pembrolizumab as an intravenous infusion over a treatment period of up to six months. Throughout the study, researchers will monitor changes in the lesions and track whether HPV is still detectable after treatment. The primary goal is to measure the proportion of participants who have no evidence of cervical HSIL at the time of final evaluation. The study is expected to conclude by January 31, 2026.

Investigational drug:

The medication being tested is pembrolizumab (also known by the brand name KEYTRUDA). This drug works by blocking a pathway called PD-1, which helps the immune system recognize and attack abnormal cells. It is classified as an immune checkpoint inhibitor and is administered as an intravenous infusion at a concentration of 25 mg/mL. By enhancing the body's natural immune response, pembrolizumab may help eliminate pre-cancerous lesions before they develop into cancer.

Summary

Currently, research into new treatments for vulvar dysplasia is limited, with only one active clinical trial available. This study is being conducted exclusively in Italy and represents an important investigation into immunotherapy approaches for high-grade HPV-related lesions. The focus on pembrolizumab reflects growing interest in using immune checkpoint inhibitors to treat pre-cancerous conditions, potentially offering an alternative to surgical interventions. The trial addresses both vulvar and cervical lesions, recognizing that HPV-related abnormalities often affect multiple areas of the reproductive system. Patients interested in participating should note that the study requires specific diagnostic confirmation and tissue samples, and eligibility is limited to female participants with documented high-grade lesions. The single-arm design means all participants will receive the same treatment, which will provide valuable information about the potential benefits of this immunotherapy approach for preventing progression to invasive cancer.