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A study to evaluate the safety and effectiveness of nivolumab and imiquimod in adults 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 study focuses on patients with Vulvar Squamous Cell Carcinoma, which is a type of cancer that starts in the thin, flat cells found on the surface of the vulva. The purpose of the study is to evaluate the safety and effectiveness of combining two different medications, nivolumab and imiquimod, for this condition. Nivolumab is a drug administered through an intravenous infusion, which means it is delivered directly into a vein, while imiquimod is a cream applied to the skin.

Participants in the study will receive these treatments to see how well the combination works in treating the cancer before surgery. The study is divided into two parts. The first part focuses on monitoring for any side effects or safety concerns caused by the medications. The second part looks at how well the combination of drugs reduces the cancer cells.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>treatment induction</b>

    The treatment period begins with an induction phase lasting for the first 6 weeks.

    During this time, nivolumab is administered through an intravenous infusion, which means it is delivered directly into a vein.

    At the same time, imiquimod is applied to the skin as a 5% cream.

  2. Step 2

    <b>safety and efficacy monitoring</b>

    The safety of the combination of nivolumab and imiquimod is monitored to identify any side effects or toxicities.

    The effectiveness of the treatment is evaluated by measuring how the vulvar squamous cell carcinoma, a type of skin cancer on the vulva, responds to the medications.

  3. Step 3

    <b>surgical assessment</b>

    At the time of surgery, the response of the tumor is documented using standardized digital photography and measurements.

    The pathological response is analyzed by looking at the tumor bed to see the percentage of dead tumor cells and other signs of reaction to the treatment.

  4. Step 4

    <b>long-term follow-up</b>

    The overall survival is tracked, which is the time from the start of treatment until death from any cause.

    The recurrence-free survival is monitored, which measures the time from the start of treatment until the cancer returns or death occurs.

    The quality of life is assessed using specific questionnaires designed to monitor well-being.

Who can join the trial?

19 criteria

  • You must be a female who is 18 years of age or older at the time of signing the consent form.
  • You must have a confirmed diagnosis of primary Vulvar Squamous Cell Carcinoma (VSCC), which is a type of cancer that starts on the vulva.
  • Your cancer must have at least one part that can be measured and is at least 10 mm in its largest size.
  • The cancer must be at a stage classified as FIGO I-III, which refers to the extent of the cancer spread according to a standardized medical system.
  • The tumor must be able to be treated with primary tumor surgery, meaning the cancer can be removed by a surgeon.
  • The surgery must be possible even if the tumor is large (greater than 4 cm), exists in multiple spots (multifocal), or if removing it would significantly affect how your body functions.
  • You must provide a tissue sample (biopsy) that has been preserved in a special way called formalin-fixed paraffin-embedded (FFPE), which is a standard method for storing tissue for testing.
  • The tissue sample must contain at least 30% tumor cells and have a surface area of at least 5mm².
  • Your ECOG Performance Status must be 2 or less, which is a scale used by doctors to measure how well you can perform daily activities and your overall physical health.
  • You must have adequate organ function, meaning your blood counts and organs are working well. This includes:
  • An Absolute Neutrophil Count (ACN) of at least 1 x 10⁹/L, which measures a specific type of white blood cell that helps fight infection.
  • A Platelet count of at least 100 x 10⁹/L, which are blood cells that help with clotting, and you must not have needed a blood transfusion for platelets in the last 7 days.
  • A Hemoglobin level of at least 9 g/dL, which is a protein in red blood cells that carries oxygen.
  • A Creatinine clearance of at least 30 mL/min, which is a measure of how well your kidneys are filtering waste from your blood.
  • A Serum total bilirubin level that is not excessively high, which is a yellow substance produced by the liver.
  • AST and ALT levels that are within a safe range, which are enzymes measured in the blood to check liver health.
  • If you are a woman able to become pregnant, you must have a negative pregnancy test within 7 days before starting treatment and agree to use effective contraception (birth control) until 5 months after your last dose of medication.
  • You must be able to understand, sign, and date the informed consent form, which is a document explaining all details of the study, and you must be willing to follow the study schedule.
  • You must have medical insurance coverage.

Who cannot join the trial?

10 criteria

  • People who are currently taking part in another clinical trial (a research study involving human participants) that is meant to treat a medical condition.
  • Women who are pregnant or currently breastfeeding.
  • People who have already received anti-cancer treatments, including specific drugs that target the immune system, such as anti-PD-1, anti-PD-L1, anti-PD-L2, or those targeting T-cell receptors like CTLA-4, OX 40, or CD37. These are medicines designed to change how your immune cells work to fight cancer.
  • People who cannot wait the required amount of time between previous treatments and starting this study, specifically: major surgery (must wait 2 weeks), live vaccines (must wait 4 weeks), or systemic corticosteroids (steroids used throughout the body) or other immunosuppressive therapy (treatments that lower the body's ability to fight infection) if the dose is high (must wait 1 week).
  • People who have another type of malignancy (cancer) that is currently growing or has needed treatment in the last 3 years. This does not include certain skin cancers or early-stage cancers that have been fully treated.
  • People with a known allergy or hypersensitivity (an extreme or unusual reaction) to any of the study drugs or the inactive ingredients used to make them.
  • People with a serious, uncontrolled infection or other ongoing diseases, or those with psychiatric illnesses (mental health conditions) that might make it difficult to follow the study rules or affect the study results.
  • People who have previously had an organ transplant or a bone marrow transplant.
  • People with an active infection of hepatitis B, hepatitis C, or HIV, or any other infection that requires medicine throughout the body.
  • People with a known or suspected autoimmune disease, which is a condition where the body's immune system mistakenly attacks its own healthy cells. This does not exclude certain skin conditions, type I diabetes, or hypothyroidism (underactive thyroid) if they are well-managed.
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Investigated drugs

  • Nivolumab

    is an immunotherapy medication given through a vein. It works by helping the body's own immune system recognize and attack cancer cells.

  • Imiquimod

    is a cream that is applied directly to the skin. It is used to stimulate the body's local immune response to help fight the cancer cells in the affected area.

What is already known about the treatment

  • Nivolumab

    This medication is administered as a liquid through a vein during an infusion. It is an established treatment used to help the body's immune system recognize and fight various types of cancer. As an immune checkpoint inhibitor, it works by blocking a specific protein on immune cells that normally prevents them from attacking cancer cells, thereby allowing the immune system to target the tumor more effectively.

  • Imiquimod

    This medication is applied directly to the skin as a cream. It is a well-known treatment used for certain skin conditions and early-stage skin cancers. It belongs to a group of drugs called immune response modifiers, which work by stimulating the body's own local immune system to recognize and destroy abnormal cells at the site where the cream is applied.

Investigated diseases

Vulvar squamous cell carcinoma - This is a type of cancer that starts in the squamous cells, which are the thin, flat cells that make up the surface of the vulva. The disease typically begins as a growth or lesion on the outer female genital area. As it progresses, the abnormal cells can grow deeper into the surrounding skin and tissues. If left unchecked, the cancerous cells may spread to nearby lymph nodes or other parts of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-524759-29-00Protocol codeET25-408Estimated enrolment50 patientsSponsorCentre Leon Berard

sourced from the EU Clinical Trials Register and site verification

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