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Not recruitingRare disease

Study of Pembrolizumab with Cisplatin or Carboplatin and Pemetrexed for Patients with Resectable Malignant Pleural Mesothelioma

Verified siteRegistered 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 type of cancer called Malignant Pleural Mesothelioma, which affects the lining of the lungs. The study is exploring a treatment that combines several medications to see how effective they are when used together before surgery. The medications being tested include Pembrolizumab, also known by its code name MK-3475, which is a type of medicine called a monoclonal antibody. This is combined with chemotherapy drugs Cisplatin or Carboplatin, and Pemetrexed. These drugs are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well this combination of medications works in treating the cancer before surgery. Participants will receive the treatment every three weeks for a total of three cycles. The study aims to see if the treatment can reduce the cancer to the point where no cancer cells are left in the tumor or nearby lymph nodes, which are small glands that help fight infection. This is known as a complete response. The study will also look at other outcomes, such as how long patients live without the cancer coming back and the overall safety of the treatment.

Throughout the study, researchers will monitor the participants' health and any side effects they may experience. The study will help determine if this combination of medications can be a successful approach to treating Malignant Pleural Mesothelioma before surgery, potentially improving outcomes for patients with this type of cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will have a confirmed diagnosis of resectable epithelioid or biphasic pleural mesothelioma. The participant must meet specific health criteria, including adequate lung function and organ health, as well as measurable disease suitable for assessment.

  2. Step 2

    Treatment cycle 1

    The participant will begin the first cycle of treatment, which includes the administration of pembrolizumab, cisplatin or carboplatin, and pemetrexed. These medications are given through an intravenous infusion.

    The dosage for cisplatin is 75 mg per square meter of body surface area, carboplatin is dosed based on the area under the curve (AUC 5), and pemetrexed is 500 mg per square meter. This treatment is administered every three weeks.

  3. Step 3

    Treatment cycle 2

    The second cycle of treatment is identical to the first, with the same medications and dosages administered intravenously every three weeks.

  4. Step 4

    Treatment cycle 3

    The third and final cycle of treatment follows the same protocol as the previous cycles, with the same medications and dosages given intravenously every three weeks.

  5. Step 5

    Surgical evaluation

    After completing the three cycles of treatment, the participant will undergo a surgical evaluation to determine the extent of the response to the treatment. The goal is to achieve a complete or major pathological response, which means a significant reduction in viable tumor cells.

  6. Step 6

    Surgery

    If the evaluation indicates that surgery is feasible, the participant will undergo surgical resection of the mesothelioma. The success of the surgery and the response to the treatment will be assessed by examining the removed tissue.

  7. Step 7

    Follow-up

    Following surgery, the participant will be monitored for any progression or recurrence of the disease. The overall response rate, event-free survival, and overall survival will be evaluated as part of the study's outcomes.

Who can join the trial?

11 criteria

  • Participants must be **male or female** and at least **18 years old** on the day they sign the consent form.
  • Participants must have a confirmed diagnosis of **surgical resectable stage I-IIIA treatment-naïve epithelioid/biphasic pleural mesothelioma**. This means the cancer is in a stage that can be removed by surgery and has not been treated before.
  • Participants must have an **ECOG performance status** of 0 to 1. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Participants must have **adequate lung function**. This is measured by tests like FEV1 (a test that measures how much air you can forcefully exhale in one second) and DLCO (a test that measures how well oxygen passes from the lungs into the blood). If these tests are not available, an oxygen level of 90% or higher on room air is acceptable.
  • Participants must have **adequate organ function** as defined by specific medical tests done within 10 days before starting the study treatment.
  • The diagnosis of **epithelioid/biphasic pleural mesothelioma** must be confirmed by a tissue sample, preferably obtained through a procedure called **video-assisted thoracoscopic surgery (VATS)**.
  • At the start of the study, it must be determined that **complete surgical removal of the mesothelioma** is possible, based on an evaluation by a team of specialists.
  • Participants must provide **written informed consent** to take part in the trial.
  • Participants must have **measurable disease**, meaning there is at least one tumor that can be measured accurately using a CT scan.
  • Participants must not have had any **previous surgical removal of mesothelioma**.
  • A **tumor tissue sample** must be provided, either from a previous biopsy or a new one. The sample should not have been treated with radiation before. New samples are preferred over older ones.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer other than Malignant Pleural Mesothelioma cannot participate. This is a specific type of cancer that affects the lining of the lungs.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to receive the medications used in the study, such as pembrolizumab, cisplatin, carboplatin, or pemetrexed, cannot participate. These are specific drugs used to treat cancer.
  • Patients who are unable to undergo the treatment schedule, which involves receiving medication every 3 weeks for 3 cycles, cannot participate.
  • Patients who are part of a vulnerable population, which means they might have additional health or social challenges, cannot 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.

  • Cisplatin

    is a chemotherapy drug used to kill cancer cells. It works by damaging the DNA of the cancer cells, which prevents them from dividing and growing.

  • Carboplatin

    is another chemotherapy medication similar to cisplatin. It is used to stop the growth of cancer cells by interfering with their DNA, making it difficult for the cells to multiply.

  • Pemetrexed

    is a chemotherapy drug that targets and disrupts the processes cancer cells need to grow and divide. It is often used in combination with other chemotherapy drugs to enhance its effectiveness against cancer.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered intravenously and is currently being studied in combination with other drugs for the treatment of malignant pleural mesothelioma. It is an immunotherapy drug that works by blocking a specific protein on immune cells, allowing the immune system to better attack cancer cells. Pembrolizumab is classified as a monoclonal antibody and is widely recognized in medical literature for its role in cancer treatment.

  • Cisplatin

    Administered intravenously, cisplatin is a chemotherapy drug used in the treatment of various cancers, including malignant pleural mesothelioma. It works by damaging the DNA of cancer cells, preventing them from dividing and growing. Cisplatin is classified as a platinum-based chemotherapy agent and is well-established in medical practice.

  • Carboplatin

    This medication is given intravenously and is used in the treatment of cancers such as malignant pleural mesothelioma. It functions similarly to cisplatin by interfering with the DNA of cancer cells, thus inhibiting their growth. Carboplatin is also a platinum-based chemotherapy drug and is commonly used in oncology.

  • Pemetrexed

    Administered intravenously, pemetrexed is used in combination with other drugs to treat malignant pleural mesothelioma. It works by disrupting the formation of DNA and RNA in cancer cells, which is essential for their growth and survival. Pemetrexed is classified as an antifolate chemotherapy agent and is a standard treatment in certain types of cancer.

Investigated diseases

Malignant Pleural Mesothelioma – Malignant Pleural Mesothelioma is a rare and aggressive cancer that primarily affects the lining of the lungs, known as the pleura. It is most commonly caused by exposure to asbestos fibers, which can lead to inflammation and scarring over time. The disease typically progresses slowly, with symptoms often appearing decades after exposure. These symptoms may include chest pain, shortness of breath, and fluid accumulation around the lungs. As the disease advances, it can spread to nearby tissues and organs, complicating the condition further. The progression of the disease can vary, but it generally involves increasing respiratory difficulties and discomfort.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509584-24-01Protocol codeCHIMERAEstimated enrolment40 patientsSponsorIstituto Oncologico Veneto

sourced from the EU Clinical Trials Register and site verification

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