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Study of Pembrolizumab for Patients with Vulvar Squamous Cell Carcinoma

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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 vulvar squamous cell carcinoma, a type of cancer that affects the vulva. The treatment being tested is called pembrolizumab, which is also known by its brand name, KEYTRUDA. Pembrolizumab is a medication that is given through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. The purpose of the study is to explore how effective pembrolizumab is when used before surgery to reduce the size of the tumor.

Participants in the study will receive pembrolizumab and will be monitored to see how the tumor responds to the treatment. The study will also look at how the body's immune cells, specifically a type of cell called effector T cells, react to the treatment. These cells are part of the immune system and help fight cancer. The study will last for several weeks, with the first assessment of the tumor size taking place approximately six weeks after the first dose of pembrolizumab.

The trial aims to gather information on the safety and effectiveness of pembrolizumab in treating vulvar squamous cell carcinoma. Researchers will also observe any changes in the tumor and the behavior of immune cells during the treatment. This study is an important step in understanding how pembrolizumab can be used to help patients with this type of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of vulvar squamous cell carcinoma and ensuring the absence of distant metastasis.

    The assessment also involves measuring the tumor size and checking organ function to ensure it meets the study's requirements.

  2. Step 2

    Informed consent

    Before any study-specific procedures, a signed written informed consent is required. This document confirms understanding and agreement to participate in the study.

  3. Step 3

    Treatment administration

    The treatment involves the administration of pembrolizumab, a medication given through an intravenous infusion. The specific product used is KEYTRUDA 25 mg/mL concentrate for solution for infusion.

    The treatment is administered as a neoadjuvant therapy, which means it is given before the main treatment, in this case, surgery.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, regular monitoring is conducted to evaluate the clinical efficacy of the treatment. This includes measuring changes in tumor size using standardized methods.

    The study also observes the activation and behavior of specific immune cells in response to the treatment.

  5. Step 5

    Surgery

    Approximately six weeks after the first administration of pembrolizumab, surgery is performed. The timing is based on the study's schedule and aims to assess the treatment's impact on the tumor.

  6. Step 6

    Post-surgery evaluation

    After surgery, further evaluations are conducted to assess the pathological response and any changes in the tumor and immune cells.

    The study also examines the feasibility and safety of the treatment, including any delays in planned surgery and surgical outcomes.

Who can join the trial?

11 criteria

  • You must sign a written informed consent form before any study-specific procedures or assessments are done.
  • You need to be at least 18 years old on the day you sign the informed consent.
  • You must have a confirmed diagnosis of primary **vulvar squamous cell carcinoma**. This means you have a type of cancer that starts in the skin cells of the vulva.
  • You should have at least one tumor that can be measured and is at least 10 mm in size.
  • Your cancer should be at a stage called **FIGO I-III**, which means it is in an early to moderate stage and has not spread to distant parts of the body.
  • You must have documentation showing that the cancer has not spread to other parts of the body, known as **distant metastasis**.
  • Your cancer should be suitable for primary surgery, meaning it can be treated with surgery first.
  • If you have more than one tumor on the vulva, the largest one must be at least 10 mm, and all tumors that are 10 mm or larger will be the focus for evaluations and biopsies.
  • You should have an **ECOG performance status** of 0-1, which means you are fully active or have some symptoms but can still carry out light work.
  • Your organs must be functioning well, as checked within 28 days before starting the study treatment.
  • If you are a female participant, you must not be pregnant or breastfeeding. You must either not be able to have children or use a highly effective birth control method, or choose to abstain from heterosexual intercourse during the study and for a certain period after the last dose of the study treatment.

Who cannot join the trial?

3 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who do not have vulvar squamous cell carcinoma cannot participate. This is a type of cancer that affects the outer part of the female genital organs.
  • Patients who are considered part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

Pembrolizumab is a medication used in this clinical trial to treat vulvar squamous cell carcinoma. It works by blocking a specific protein called PD-1 on the surface of immune cells. This action helps the immune system to better recognize and attack cancer cells. The trial aims to see if using Pembrolizumab before surgery can reduce the size of the tumor and improve the body's immune response against the cancer.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently well-established in medical literature as an immunotherapy used for various cancers, including vulvar squamous cell carcinoma. The main therapeutic indication for Pembrolizumab in this context is to reduce tumor size before surgery. At the molecular level, it works by blocking the PD-1 pathway, which enhances the immune system's ability to attack cancer cells. Pembrolizumab is classified as a monoclonal antibody and is part of the broader category of immune checkpoint inhibitors.

Investigated diseases

Vulvar Squamous Cell Carcinoma – This is a type of cancer that occurs on the outer surface area of the female genitalia, specifically the vulva. It originates in the squamous cells, which are the thin, flat cells that line the surface of the vulva. The disease often begins as a precancerous condition known as vulvar intraepithelial neoplasia, which can progress to invasive cancer if not treated. As the carcinoma develops, it may form a noticeable lump or sore on the vulva, which can be painful or itchy. Over time, the cancer can spread to nearby tissues, including the lymph nodes. The progression of the disease can vary, with some cases remaining localized while others may advance more aggressively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512862-32-00Protocol codeNL82378.058.22Estimated enrolment40 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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