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Study of Volrustomig with Carboplatin and Pemetrexed for Patients with Unresectable Pleural Mesothelioma

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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 unresectable pleural mesothelioma, which is a type of cancer that affects the lining of the lungs and cannot be removed through surgery. The study is testing a new treatment option that combines a medication called volrustomig (also known by its code name MEDI5752) with two other drugs, carboplatin and pemetrexed. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The trial will compare this new combination treatment to other standard treatments, which include either a combination of nivolumab and ipilimumab or a combination of platinum-based drugs with pemetrexed.

The purpose of the study is to determine if the new treatment combination is more effective in improving the overall survival of patients with pleural mesothelioma compared to the standard treatments. Participants in the study will receive one of the treatment options and will be monitored over time to assess their response to the treatment and any side effects they may experience. The study will also look at other factors such as how long the treatment works, the time it takes for the disease to progress, and the overall response rate to the treatment.

Throughout the study, participants will undergo regular check-ups, which may include physical exams, blood tests, and other assessments to monitor their health and the effects of the treatment. The trial aims to provide valuable information that could lead to better treatment options for people with pleural mesothelioma 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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of pleural mesothelioma, and overall health status.

    The study involves participants with advanced pleural mesothelioma that cannot be treated with surgery.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of the treatment groups.

    The study compares the effectiveness of different treatment combinations.

  3. Step 3

    Treatment administration

    Participants receive treatments through intravenous use or orally, depending on the assigned group.

    One group receives volrustomig in combination with carboplatin and pemetrexed.

    Another group receives a combination of nivolumab and ipilimumab or a combination of platinum and pemetrexed.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular monitoring to assess overall survival and progression-free survival.

    Additional assessments include response rate, duration of response, and safety evaluations.

  5. Step 5

    Follow-up

    Participants continue to be monitored for overall survival and any changes in disease-related symptoms.

    The study aims to collect data on the long-term effects and safety of the treatments.

Who can join the trial?

6 criteria

  • The participant must be at least 18 years old at the time of screening.
  • The participant must have a confirmed diagnosis of pleural mesothelioma, which is a type of cancer affecting the lining of the lungs, with a known type (either epithelioid or non-epithelioid).
  • The disease must be advanced and cannot be removed by surgery aimed at curing it, with or without chemotherapy.
  • The participant must have a **WHO/ECOG performance status** of 0 or 1. This means they should be fully active or have some symptoms but be able to carry out light work, with no worsening of their condition in the two weeks before starting the treatment.
  • The participant must have a disease that can be measured using a specific method called **modified RECIST1.1**.
  • The participant must have enough healthy bone marrow and properly working organs at the start of the study.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have had another type of cancer in the past, unless it was treated and has not come back for a certain period.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had an allergic reaction to any of the study drugs or similar drugs in the past.
  • Patients with certain infections that are not well controlled.
  • Patients who have received certain treatments for their condition recently, which might affect the study results.
  • Patients with a history of drug or alcohol abuse that could interfere with the study.
  • Patients who have had a major surgery recently.
  • Patients with certain heart conditions that are not well controlled.
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Investigated drugs

  • Volrustomig (MEDI5752)

    is an investigational medication being studied for its potential to treat pleural mesothelioma. It is being tested in combination with other cancer treatments to see if it can improve survival rates in patients with this type of cancer.

  • Carboplatin

    is a chemotherapy drug used to treat various types of cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

  • Pemetrexed

    is another chemotherapy medication that is often used in combination with other drugs to treat certain types of lung cancer, including pleural mesothelioma. It works by blocking the cancer cells' ability to use folate, which is necessary for their growth.

  • Nivolumab

    is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used to treat various types of cancer by blocking a protein that prevents the immune system from attacking cancer cells.

  • Ipilimumab

    is also an immunotherapy medication that works by activating the immune system to fight cancer. It is often used in combination with other drugs to enhance the body's ability to target and destroy cancer cells.

What is already known about the treatment

Volrustomig – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating unresectable pleural mesothelioma. It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication is for use in combination with carboplatin and pemetrexed to potentially improve survival outcomes in patients with this type of cancer. At the molecular level, volrustomig is designed to target specific pathways that may help the immune system better recognize and attack cancer cells. It is classified as an immunotherapy agent.

Investigated diseases

Unresectable Pleural Mesothelioma – This is a type of cancer that occurs in the thin layer of tissue covering the lungs and chest wall, known as the pleura. It is termed "unresectable" when the tumor cannot be removed through surgery. The disease is primarily caused by exposure to asbestos fibers, which can lead to the development of cancerous cells in the pleura. As the disease progresses, it can cause symptoms such as chest pain, shortness of breath, and fluid buildup around the lungs. The cancer cells can spread to nearby tissues and organs, making it challenging to manage. Over time, the disease can significantly impact lung function and overall health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503231-17-00Protocol codeD7988C00001Estimated enrolment825 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).