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Study of Pembrolizumab and Lenvatinib for Patients with Advanced Vulvar Cancer Not Suitable for Surgery or Radiotherapy

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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 a type of cancer called vulvar cancer, which affects the external part of the female genital organs. The study is specifically for cases where the cancer has come back, is persistent, has spread to other parts of the body, or is locally advanced and cannot be treated with surgery or radiation to cure it. The trial will use a combination of two medications: Pembrolizumab and Lenvatinib. Pembrolizumab is given as an infusion, which means it is administered directly into the bloodstream through a vein, while Lenvatinib is taken orally in the form of capsules.

The purpose of this study is to evaluate how effective the combination of Pembrolizumab and Lenvatinib is in treating vulvar cancer. Participants in the study will receive these medications and will be monitored to see how their cancer responds to the treatment. The study will look at how many patients experience a reduction in their cancer size or complete disappearance of the cancer within 24 weeks of starting the treatment. The study will also assess the overall health and quality of life of the participants during the trial.

Throughout the study, participants will be regularly checked by healthcare professionals to monitor their response to the treatment and any side effects they may experience. The trial aims to provide valuable information on the effectiveness of this treatment combination for vulvar cancer, which could help improve future treatment options for patients with this condition.

The research process

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

Step 1
Initial treatment phase
The treatment begins with the administration of pembrolizumab through an intravenous infusion. This is a solution for infusion and is given at a dose of 25 mg/mL.
Alongside pembrolizumab, lenvatinib is taken orally in the form of capsules. The specific dosage and frequency of lenvatinib will be determined by the healthcare provider based on individual patient needs.
Step 2
Treatment monitoring
Throughout the treatment, regular monitoring is conducted to assess the response to the medications. This includes evaluating the objective response rate (ORR), which measures the proportion of patients with partial or complete response within 24 weeks from the start of the treatment.
Tumor responses are assessed using criteria known as RECIST 1.1, which helps in determining the effectiveness of the treatment.
Step 3
Ongoing assessment
The overall response rate is evaluated for the entire duration of the trial. This includes measuring the disease control rate (DCR), duration of response (DOR), overall survival (OS), and progression-free survival (PFS).
Quality of life is assessed using patient-reported outcome instruments, specifically the EORTC QLQ-C30 and QLQ-VU34 questionnaires.
Step 4
Adverse events monitoring
Any adverse events are recorded according to the common terminology criteria for adverse events (CTCAE Version 5.0).
Adjustments to the treatment, such as dose reductions, delays, or interruptions, may be made based on the occurrence of adverse events.
Step 5
Completion of trial
The trial is estimated to conclude by December 1, 2029. The duration of participation for each patient may vary depending on individual response and any adjustments made during the trial.

Who can join the trial?

9 criteria

The patient must sign a written document to show they understand and agree to the study's requirements.
The patient must be a woman who is at least 18 years old.
The patient must have a confirmed diagnosis of vulvar cancer that is advanced, has come back, or has spread, and cannot be treated with surgery or radiation meant to cure it. Radiation to help with symptoms is allowed.
The patient must have had no more than two previous treatments with chemotherapy for cancer that has come back or spread.
The patient must have a measurable disease, which means the cancer can be measured by doctors using specific guidelines. If the cancer is in an area that was treated with radiation before, it can still be measured if it has grown since then.
The patient must have a good level of daily functioning, as assessed by a specific scale called the **ECOG performance status**, which should be checked within 7 days before starting the study treatment.
The patient must not be pregnant or breastfeeding. If the patient is a woman who can have children, she must agree to use effective birth control during the study and for at least 6 months after the last treatment. She should not become pregnant during this time.
The patient must provide a sample of their tumor tissue, either from a previous test or a new biopsy, ideally from an area that has not been treated with radiation before. The sample should be preserved in a specific way, using a method called **formalin-fixed, paraffin-embedded (FFPE)**.
The patient must have organs that are working well enough, as defined by specific medical tests, which should be done within 10 days before starting the study treatment.

Who cannot join the trial?

3 criteria

Patients with other types of cancer that are not **recurrent, persistent, metastatic, or locally advanced vulvar cancer** cannot participate. **Recurrent** means the cancer has come back after treatment. **Persistent** means the cancer has not gone away after treatment. **Metastatic** means the cancer has spread to other parts of the body. **Locally advanced** means the cancer has spread to nearby areas but not to distant parts of the body.
Only **female** patients can participate in this study.
Patients who are considered part of a **vulnerable population** are not eligible. A vulnerable population includes groups of people who may need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
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Kliniken Essen-Mitte,Evangelische Huyssens-Stiftung
Essen, Germany
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Klinikum der Universitaet Muenchen AöR
Munich, Germany

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Investigated drugs

Pembrolizumab
is a type of immunotherapy that helps your immune system fight cancer. It works by blocking a specific protein on cancer cells, which allows your immune system to better recognize and attack these cells.
Lenvatinib
is a targeted therapy that works by blocking certain proteins that help cancer cells grow and spread. It interferes with the blood supply to the tumor, which can slow down or stop the growth of cancer cells.

What is already known about the treatment

Pembrolizumab
This medication is administered intravenously and is currently being studied in combination with lenvatinib for treating vulvar cancer that is recurrent, persistent, metastatic, or locally advanced. Pembrolizumab is well-documented in medical literature as an immune checkpoint inhibitor, primarily used in various cancers. It works by blocking the PD-1 pathway, enhancing the immune system's ability to detect and fight cancer cells. Pembrolizumab is classified as a monoclonal antibody.
Lenvatinib
This medication is taken orally and is being evaluated alongside pembrolizumab for its effectiveness in treating certain types of vulvar cancer. Lenvatinib is recognized in medical literature as a multi-kinase inhibitor, which interferes with specific proteins that promote cancer cell growth and blood vessel formation. It is primarily used in the treatment of thyroid cancer, renal cell carcinoma, and hepatocellular carcinoma. Lenvatinib belongs to the pharmacological class of tyrosine kinase inhibitors.

Investigated diseases

Vulvar Cancer – Vulvar cancer is a type of cancer that occurs on the outer surface area of the female genitalia. It often begins as a lump or sore on the vulva that may cause itching or discomfort. As the disease progresses, it can invade deeper tissues and spread to nearby lymph nodes. Recurrent vulvar cancer refers to cancer that has returned after treatment. Persistent vulvar cancer is when the cancer does not completely go away with treatment. Metastatic vulvar cancer indicates that the cancer has spread to other parts of the body beyond the vulva.