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Study of Pembrolizumab and Lenvatinib for Patients with Malignant Pleural Mesothelioma in Second and Third Line Treatment

Registered 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 a disease called malignant pleural mesothelioma, which is a type of cancer that affects the lining of the lungs. The study is testing a combination of two treatments: pembrolizumab and lenvatinib. Pembrolizumab is a medication that is given through an infusion, which means it is delivered directly into the bloodstream through a vein. Lenvatinib is taken as a capsule by mouth. The purpose of the study is to see how well these two medications work together in treating patients who have already received other treatments for their cancer.

Participants in the study will receive both pembrolizumab and lenvatinib. The study will follow patients over a period of time to observe how their cancer responds to the treatment. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment. The study aims to determine the effectiveness of the treatment combination in shrinking or controlling the cancer.

The trial is designed to help understand the potential benefits and side effects of using pembrolizumab and lenvatinib together for treating malignant pleural mesothelioma. By participating in the study, researchers hope to gather valuable information that could lead to better treatment options for this type of cancer 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of malignant pleural mesothelioma and ensuring previous treatment with specific therapies.

    The assessment also involves checking overall health status, including organ function and blood pressure, to ensure it meets the study's requirements.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of two medications: lenvatinib and pembrolizumab.

    Lenvatinib is taken orally in the form of hard capsules. The dosage is determined by the study protocol and is adjusted based on individual health factors.

    Pembrolizumab is administered intravenously as a solution for infusion. The frequency and dosage are specified by the study guidelines.

  3. Step 3

    Ongoing monitoring

    Throughout the study, regular monitoring is conducted to assess the response to treatment. This includes imaging tests to measure changes in the disease.

    Health status is continuously evaluated to manage any side effects or adverse reactions to the medications.

  4. Step 4

    Treatment cycles

    The treatment is administered in cycles, with each cycle consisting of a specific duration as outlined in the study protocol.

    An optional biopsy may be performed before the third treatment cycle to gather additional information about the disease's response to the therapy.

  5. Step 5

    Completion of study

    The study is estimated to conclude by March 2026. Upon completion, a final assessment is conducted to evaluate the overall response to the treatment.

    Participants are provided with information about their health status and any further steps that may be necessary.

Who can join the trial?

16 criteria

  • The patient must have been diagnosed with **malignant pleural mesothelioma**, which is a type of cancer affecting the lining of the lungs.
  • The patient must be at least 18 years old.
  • Male participants must agree to use **contraception**, which means using methods to prevent pregnancy.
  • The patient should have an expected life span of at least 3 months.
  • The patient must have a **progressive disease**, meaning the disease is getting worse, after having 1 or 2 previous treatments. There are two groups:
    • Group 1: Patients who had a treatment that included a **platinum-based doublet**, which is a type of chemotherapy, for cancer that cannot be removed by surgery.
    • Group 2: Patients who only had **nivolumab-ipilimumab immunotherapy** as their first treatment for cancer that cannot be removed by surgery, with no prior chemotherapy.
    • The patient must have a **measurable disease**, meaning there is at least one tumor that can be measured in size.
    • The patient must have a **WHO-ECOG performance status** of 0 to 1, which is a scale to measure how well a patient can perform daily activities.
    • The patient must have **adequate organ function**, which means their organs are working well enough. This includes:
      • Blood: Enough white blood cells, platelets, and hemoglobin.
      • Liver: Normal levels of bilirubin and liver enzymes.
      • Kidneys: Normal protein levels in urine and creatinine levels.
      • Blood clotting: Normal **INR** levels unless on blood-thinning medication.
      • The patient must be able to understand the study and sign a consent form, or have a representative do so if needed.
      • The patient must have **controlled blood pressure**, meaning it is at or below 150/90 mmHg.
      • Female patients must not be pregnant or breastfeeding.
      • Women who can have children must use contraception to prevent pregnancy during the study and for 120 days after.

Who cannot join the trial?

10 criteria

  • Patients who have not been previously treated for their condition cannot participate.
  • Patients who are part of a vulnerable population, meaning those who might need special protection or care, are not eligible.
  • Patients who do not meet the age requirements for the study cannot join. The study is open to adults only.
  • Patients with other serious health conditions that could interfere with the study treatment are excluded.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have had another type of cancer in the past, unless it was successfully treated and is not currently active, are not eligible.
  • Patients who are currently participating in another clinical trial are not allowed to join this study.
  • Patients who have allergies or reactions to the study medications cannot participate.
  • Patients who have had a recent major surgery or are recovering from surgery are excluded.
  • Patients with certain infections, like HIV or hepatitis, are not eligible to participate.
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Investigated drugs

  • Pembrolizumab

    is a type of immunotherapy that helps the body's immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells.

  • Lenvatinib

    is a targeted therapy that works by interfering with the growth of cancer cells. It blocks certain proteins that cancer cells need to grow and spread, helping to slow down or stop the progression of the disease.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered as an intravenous infusion. It is currently used in medicine as an immunotherapy for various cancers, including malignant pleural mesothelioma. The main therapeutic indication is to help the immune system detect and fight cancer cells. At the molecular level, pembrolizumab works by blocking the PD-1 pathway, which cancer cells use to hide from the immune system. It is classified as a monoclonal antibody.

  • Lenvatinib

    Lenvatinib is taken orally in the form of capsules. It is used in the treatment of certain types of cancer, including malignant pleural mesothelioma, as part of ongoing clinical research. The primary therapeutic indication is to inhibit tumor growth and spread. Lenvatinib works by blocking specific proteins involved in the growth of blood vessels that supply tumors, known as tyrosine kinase inhibitors. It is classified as a targeted therapy.

Investigated diseases

Malignant Pleural Mesothelioma – This is a rare and aggressive cancer that affects the lining of the lungs, known as the pleura. It is primarily caused by exposure to asbestos fibers, which can lead to inflammation and scarring over time. The disease often begins with symptoms such as chest pain, shortness of breath, and persistent cough. As it progresses, it can cause fluid buildup around the lungs, known as pleural effusion, which exacerbates breathing difficulties. The cancer cells can spread to nearby tissues and organs, complicating the condition further. Malignant pleural mesothelioma is known for its long latency period, meaning symptoms may not appear until decades after asbestos exposure.
Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516618-39-00Estimated enrolment58 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

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