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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication pembrolizumab, also known by its code name MK-3475, on certain types of lesions related to the human papillomavirus (HPV). Specifically, the study is looking at pre-cancerous high-grade lesions found in the vulva and cervix, which are areas of the female reproductive system. These lesions are known as cervical high-grade squamous intraepithelial lesions (HSIL) and vulvar intraepithelial neoplasia (VIN) 2-3. The purpose of the study is to determine how effective pembrolizumab is in causing these lesions to completely regress, meaning they disappear or reduce significantly.

Participants in the study will receive pembrolizumab through an intravenous infusion, which means the medication is given directly into a vein. The study will follow a single-arm design, meaning all participants will receive the same treatment without a comparison group. The treatment period is expected to last up to six months. Throughout the study, participants will be monitored for changes in their lesions and any side effects they may experience. The study aims to see if pembrolizumab can help reduce or eliminate the lesions and prevent them from progressing to more serious conditions like cancer.

The study will also track the presence of HPV in participants and assess whether the virus is still detectable after treatment. By the end of the study, researchers hope to gather valuable information on the potential benefits of pembrolizumab for treating these specific HPV-related lesions. This could lead to new treatment options for individuals with similar conditions in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Eligible participants are female, at least 18 years old, with a confirmed diagnosis of high-grade HPV-related vulvar or cervical lesions.

    Participants must not be pregnant or breastfeeding and must agree to use contraception during the study and for three months after the last dose.

    Participants provide written informed consent and a tissue sample from a biopsy for study purposes.

  2. Step 2

    Initial assessment

    Participants undergo an evaluation of their general health status using the Eastern Cooperative Oncology Group (ECOG) performance status scale, which ranges from 0 (fully active) to 1 (restricted in physically strenuous activity but ambulatory).

    Adequate organ function is confirmed through laboratory tests conducted within 10 days before starting the treatment.

  3. Step 3

    Treatment administration

    Participants receive pembrolizumab, a medication administered as an intravenous infusion.

    The specific product used is KEYTRUDA 25 mg/mL concentrate for solution for infusion.

    The treatment aims to achieve complete regression of cervical high-grade squamous intraepithelial lesions (HSIL).

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for the presence of cervical HSIL and vulvar VIN 2-3 lesions through histological examinations.

    The study evaluates the absence of HPV infection at the Week 36 visit.

    Participants are observed for any systemic events and their severity throughout the study duration.

  5. Step 5

    Completion

    The study is expected to conclude by January 31, 2026.

    The primary goal is to determine the proportion of participants with no evidence of cervical HSIL at the time of surgical treatment.

Who can join the trial?

6 criteria

  • Female participants who are at least 18 years old can join the study if they have a confirmed diagnosis of cervical HSIL or vulvar VIN 2-3 lesions. These are specific types of abnormal cell growths in the cervix or vulva.
  • Participants must not be pregnant or breastfeeding. If they can have children, they must agree to use birth control during the study and for at least 3 months after the last treatment.
  • The participant, or their legal representative, must provide written consent to join the trial.
  • Participants need to provide a sample of the tumor tissue. This can be from a previous biopsy or a new one. The sample should be in a specific form called formalin-fixed, paraffin-embedded (FFPE) tissue blocks, which is preferred over slides.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Participants must have adequate organ function, which will be checked with tests done within 10 days before starting the study treatment.

Who cannot join the trial?

4 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who do not have high-grade HPV-related vulvar and cervical lesions cannot participate. HPV stands for Human Papillomavirus, which can cause changes in the skin or mucous membranes.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study but is not specified here.
  • Patients who are considered part of a vulnerable population may not be eligible. A vulnerable population includes groups who may have limited ability to protect their own interests.
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Investigated drugs

Pembrolizumab is a medication used in this clinical trial to treat high-grade pre-cancerous lesions related to HPV in the vulvar and cervical areas. It works by helping the immune system recognize and attack cancer cells, potentially leading to the complete regression of these lesions.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently being studied in clinical trials for its effectiveness in treating pre-neoplastic high-grade HPV-related vulvar and cervical lesions. The main therapeutic indication for Pembrolizumab in this context is to achieve complete regression of cervical high-grade squamous intraepithelial lesions (HSIL). At the molecular level, Pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor in pharmacology.

Investigated diseases

  • High-Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix

    This condition involves abnormal changes in the cells on the surface of the cervix, often caused by persistent infection with high-risk types of human papillomavirus (HPV). These changes are considered pre-cancerous, meaning they have the potential to develop into cervical cancer if not monitored or treated. HSIL is typically identified through screening tests like Pap smears and confirmed with a biopsy. The progression from HSIL to cervical cancer can take several years, but not all HSIL cases will progress to cancer. Regular monitoring and follow-up are crucial to manage and prevent progression.

  • Vulvar Intraepithelial Neoplasia (VIN) 2-3

    This condition refers to the presence of abnormal cells on the surface of the vulva, which are considered pre-cancerous. VIN 2-3 indicates moderate to severe dysplasia, which means the cells have a higher likelihood of progressing to vulvar cancer if left untreated. The condition is often associated with HPV infection, similar to cervical HSIL. Symptoms may include itching, burning, or changes in the skin of the vulva, but some individuals may not experience noticeable symptoms. Monitoring and treatment are important to prevent progression to invasive cancer.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504035-40-00Protocol codeMITO CERV 4Estimated enrolment45 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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