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Study of pembrolizumab and lenvatinib treatment for patients with vulvar cancer

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What is this trial about?

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

This clinical trial focuses on patients with vulvar cancer, a type of cancer that develops in the external part of the female reproductive organs. The study will test a combination of two medications: Pembrolizumab (also known as KEYTRUDA), which is given through an intravenous infusion, and Lenvatinib, which is taken as an oral capsule. The purpose of this research is to determine how well these medications work together and how safe they are for treating vulvar cancer patients.

The study is designed for different groups of patients with vulvar cancer: those with tumors that cannot be removed by surgery, those who have never received chemotherapy for their recurrent or spreading cancer, and those whose cancer has returned after previous treatment or has spread despite chemotherapy. The treatment involves receiving both medications - Pembrolizumab through an infusion into a vein and Lenvatinib as daily capsules.

During the study, doctors will monitor how the cancer responds to the treatment combination and watch for any side effects. Patients will have regular check-ups and medical tests to evaluate their health status. The medication doses are carefully determined - Pembrolizumab will be given at 200 mg through infusion, while Lenvatinib will be given at 20 mg daily in capsule form.

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

    Initial examination and tests

    A medical examination will be performed to confirm your eligibility for the trial, including blood tests to check organ function and blood counts

    Your blood pressure must be ≤140/90 mmHg to participate

    A pregnancy test will be required if you are able to become pregnant

    A tumor sample analysis will be performed before enrollment

  2. Step 2

    Treatment initiation

    You will receive two medications during the trial:

    Lenvatinib - taken as capsules by mouth daily

    Pembrolizumab (KEYTRUDA) - given through an intravenous infusion (into a vein)

  3. Step 3

    Treatment cycles and monitoring

    Your response to treatment will be evaluated after 4 treatment cycles if you have a primary tumor

    Regular assessments will be performed to monitor your condition throughout the treatment period

    Blood tests and imaging scans will be conducted to track your progress

    Side effects will be monitored using standardized criteria

  4. Step 4

    Safety monitoring

    Regular check-ups will include:

    Blood pressure measurements

    Blood tests to monitor organ function

    Assessment of any side effects

    Completion of questionnaires about your experience with the treatment

  5. Step 5

    Long-term follow-up

    The study will continue until September 2031

    Regular monitoring will continue throughout your participation in the trial

    Your response to treatment will be assessed using standardized criteria to measure tumor changes

Who can join the trial?

12 criteria

  • Must be female and at least 18 years old
  • Must have signed an informed consent form before any study procedures
  • Must have confirmed vulvar cancer that is either: - Too large to be removed by surgery, or - Has come back after previous treatment, or - Has spread to other parts of the body
  • Must have at least one tumor that can be measured
  • Must have good overall physical function (able to carry out all light daily activities)
  • Must have normal organ and bone marrow function, including: - Adequate blood count - Proper liver function - Good kidney function
  • Must have well-controlled blood pressure (140/90 or lower)
  • Must be able to take medications by mouth
  • Must have a life expectancy of at least 16 weeks
  • Must provide a tumor tissue sample for testing
  • If able to become pregnant: - Must have a negative pregnancy test - Must use highly effective birth control - Must not be pregnant or breastfeeding
  • Must be willing and able to attend all scheduled visits and follow the study plan

Who cannot join the trial?

15 criteria

  • Age below 18 years old
  • Male patients (study is for females only)
  • Current pregnancy or breastfeeding
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • History of other malignancies (other types of cancer) within 2 years before starting the study
  • Severe heart conditions including:
    • Heart failure
    • Unstable angina (chest pain)
    • Recent heart attack within last 6 months
    • Severe kidney disease requiring dialysis (blood filtering treatment)
    • Active autoimmune disease (condition where immune system attacks healthy cells)
    • Active infection requiring systemic treatment (medication that affects the whole body)
    • Previous treatment with similar medications (pembrolizumab or lenvatinib)
    • Participation in another clinical trial within 30 days before starting this study
    • Known allergic reactions to the study medications
    • Psychological or social conditions that would interfere with study participation
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Investigated drugs

Pembrolizumab is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein called PD-1, which allows your body's immune cells to better recognize and attack cancer cells. This medication is given through an intravenous (IV) infusion. Lenvatinib is a targeted therapy medication that works by blocking certain proteins that help cancer cells grow and survive. It specifically interferes with the formation of new blood vessels that feed tumors. This medication is taken by mouth in the form of capsules. The combination of these two medications is being studied to treat vulvar cancer, with the goal of determining how well they work together and how safe this combination is for patients.

What is already known about the treatment

  • Pembrolizumab

    An immunotherapy medication administered through intravenous infusion that belongs to the class of PD-1 inhibitors. This monoclonal antibody works by helping the immune system detect and fight cancer cells by blocking the PD-1 pathway that cancer cells use to hide from immune cells. It is used in various types of cancer treatment, including vulvar cancer, and has shown significant effectiveness in clinical trials when combined with other therapies.

  • Lenvatinib

    An oral medication taken in capsule form that belongs to the class of targeted therapy drugs known as kinase inhibitors. This drug works by blocking specific proteins that help cancer cells grow and survive, particularly by inhibiting the formation of new blood vessels that feed tumors. It has demonstrated effectiveness in treating various types of cancer and is being studied in combination with pembrolizumab for vulvar cancer treatment, showing promising results in clinical trials.

Investigated diseases

Vulvar Cancer - A rare type of cancer that develops in the vulva, which is the external part of the female genitals. The disease typically begins in the outer layer of skin cells of the vulva. It most commonly affects the labia, but can occur on any part of the external female genitalia. The condition usually develops slowly over several years, often starting with precancerous changes in the skin cells. As the disease progresses, it can cause symptoms such as persistent itching, pain, tenderness, or bleeding in the vulvar area. The cancer can appear as a lump or growth on the vulva that might be red, pink, or white in color.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509180-24-00Protocol codeMITO VULVA-01Estimated enrolment80 patientsSponsorIRCCS Istituto Nazionale Tumori Fondazione Pascale

sourced from the EU Clinical Trials Register and site verification

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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.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).