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Study on Neoadjuvant Chemotherapy and Immunotherapy with Ipilimumab, Pemetrexed, and Drug Combination for Patients with Inoperable 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 inoperable pleural mesothelioma, which affects the lining of the lungs. The study aims to explore the effectiveness of a combination of treatments, including chemotherapy and immunotherapy, to see if they can help make the cancer operable. The chemotherapy drugs being used in this study are Armisarte (pemetrexed), Cisplatin Accord Healthcare (cisplatin), and Carboplatine Fresenius Kabi (carboplatin). The immunotherapy drugs involved are YERVOY (ipilimumab) and OPDIVO (nivolumab). These treatments are given as solutions through a vein, known as intravenous infusion.

The purpose of the study is to assess how well patients can complete this new treatment plan and whether it can make surgery possible for those who were initially considered inoperable. The study will involve two cycles of the combined chemotherapy and immunotherapy treatments. After these treatments, doctors will evaluate if the cancer has shrunk enough to allow for surgery. The study will also monitor the safety of the treatments and any side effects that may occur.

Participants in the study will be closely observed to see if the treatment helps them live longer without the cancer getting worse. The study will also look at the quality of life of the participants during and after the treatment. The ultimate goal is to find out if this combination of treatments can improve outcomes for patients with inoperable pleural mesothelioma.

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

    Initial treatment phase

    The treatment begins with the administration of medications through an intravenous infusion. This involves the use of ipilimumab, pemetrexed, cisplatin, carboplatin, and nivolumab. Each medication is given as a solution for infusion.

    The purpose of this phase is to prepare the body for potential surgery by reducing the size of the tumor and assessing the body's response to the treatment.

  2. Step 2

    Evaluation of operability

    After completing the initial treatment phase, an evaluation is conducted to determine if the tumor has become operable. This assessment is based on imaging studies and the criteria set by the radiology department.

    The goal is to identify patients who can proceed to surgery after the neoadjuvant therapy.

  3. Step 3

    Surgical consideration

    If the tumor is deemed operable, the patient may proceed to surgery. The decision is made by a multidisciplinary team based on the response to the initial treatment.

    The surgery aims to remove as much of the tumor as possible, improving the chances of long-term control of the disease.

  4. Step 4

    Post-treatment monitoring

    Following the treatment and potential surgery, regular monitoring is conducted to assess the patient's health and detect any signs of disease progression.

    This includes follow-up visits, imaging studies, and assessments of quality of life using standardized scoring systems.

Who can join the trial?

6 criteria

  • Must be able to provide written consent and follow the study procedures.
  • Must have a confirmed diagnosis of **pleural mesothelioma** with a specific type called **epithelioid**. The cancer stage should be **cT2-3 N0-1 M0** according to a system called **UICC TNM 9**, and it should be considered inoperable by a group of medical experts. Patients may become eligible for surgery if they respond well to initial treatments.
  • Must be **18 years or older**.
  • Must have a **World Health Organization (WHO) Performance Status** of **0-1**, which means the patient is fully active or has some symptoms but can still carry out light work.
  • Must be in good enough health to undergo **systemic chemotherapy**, **immunotherapy**, and **surgery** as per standard medical practices.
  • Pregnancy is not allowed. Women who can become pregnant must use effective birth control to prevent pregnancy. Men must also use effective birth control to prevent pregnancy in their female partners.

Who cannot join the trial?

4 criteria

  • Patients with **inoperable pleural mesothelioma** cannot participate. This means the disease cannot be removed through surgery.
  • Patients who do not fall within the age range specified for the study are excluded. The study is open to certain age groups only.
  • Patients who are not classified as T2-T3 according to **TNM 9** are excluded. TNM is a system used to describe the size and spread of cancer.
  • Patients who are part of a vulnerable population are not eligible. This means people who might need special protection or care.
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Investigated drugs

  • Neoadjuvant Chemotherapy

    is a treatment given before the main treatment, which in this case is surgery. It involves using drugs to shrink the tumor in patients with pleural mesothelioma, making it easier to remove during surgery. This approach aims to improve the chances of successful surgery and overall outcomes for the patient.

  • Immunotherapy

    is a type of cancer treatment that helps the immune system fight cancer. In this trial, immunotherapy is used alongside chemotherapy to enhance the body's natural defenses against pleural mesothelioma. The goal is to improve the effectiveness of the treatment by combining the strengths of both chemotherapy and immunotherapy.

What is already known about the treatment

  • Cisplatin

    Cisplatin is administered intravenously and is commonly used in combination with other medications for treating various types of cancer, including inoperable pleural mesothelioma. It is well-established in medical literature as a chemotherapy agent. The main therapeutic indication is to help shrink tumors and slow the progression of cancer. At the molecular level, cisplatin works by binding to DNA in cancer cells, causing cross-linking and ultimately leading to cell death. It is classified as a platinum-based chemotherapy drug.

  • Pembrolizumab

    Pembrolizumab is administered through an intravenous infusion and is used in the treatment of several cancers, including inoperable pleural mesothelioma, as part of immunotherapy regimens. It is widely recognized in medical literature for its role in cancer treatment. The primary therapeutic indication is to enhance the body's immune response against cancer cells. Pembrolizumab works by blocking the PD-1 pathway, which cancer cells use to evade the immune system, thereby allowing immune cells to attack the cancer. It is classified as a monoclonal antibody and immune checkpoint inhibitor.

Investigated diseases

Inoperable Pleural Mesothelioma – This is a type of 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 the development of tumors in the pleural lining. The disease progresses as these tumors grow and spread, causing symptoms such as chest pain, shortness of breath, and fluid buildup around the lungs. As the condition advances, it can lead to more severe respiratory issues and discomfort. The term "inoperable" indicates that the tumors cannot be surgically removed due to their location, size, or the patient's overall health. This condition is considered rare and requires specialized medical attention.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504302-11-02Estimated enrolment37 patientsSponsorAntwerp University Hospital

sourced from the EU Clinical Trials Register and site verification

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