Study of new combined therapy for untreatable lung membrane cancer

Recruting new patients

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    What is this study about?

    This study is testing a new treatment for pleural mesothelioma, a type of lung cancer. It compares a new drug, Volrustomig combined with carboplatin and pemetrexed, against drugs chosen by the researcher, which could include platinum, pemetrexed, nivolumab, or ipilimumab. The goal is to see which treatment works better and is safer. About 600 adults with advanced mesothelioma that can’t be removed by surgery will participate. The study will look at how long patients live with each treatment and other health factors.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Anderlecht , Belgium

      Antwerpen , Belgium

      Gent , Belgium

      Hasselt , Belgium

      Sint-Niklaas , Belgium

      Aarhus N , Denmark

      Copenhagen , Denmark

      Brest , France

      Creteil Cedex , France

      Le Mans Cedex , France

      Lille , France

      Lyon , France

      Marseille Cedex 20 , France

      Montpellier , France

      Paris Cedex 18 , France

      Rouen , France

      Saint Herblain , France

      Strasbourg , France

      Toulouse , France

      Berlin , Germany

      Essen , Germany

      Gauting , Germany

      Georgsmarienhuette , Germany

      Heidelberg , Germany

      Ku00f6ln , Germany

      Mu00fcnster , Germany

      Alessandria , Italy

      Bari , Italy

      Bergamo , Italy

      Milan , Italy

      Monza , Italy

      Orbassano , Italy

      Padova , Italy

      Parma , Italy

      Rozzano , Italy

      Varese , Italy

      Amsterdam , Netherlands

      Eindhoven , Netherlands

      Rotterdam , Netherlands

      Lu00f8renskog , Norway

      Oslo , Norway

      Bydgoszcz , Poland

      Bystra , Poland

      Olsztyn , Poland

      Poznau0144 , Poland

      Rzeszu00f3w , Poland

      Warszawa , Poland

      Barakaldo , Spain

      Barcelona , Spain

      Madrid , Spain

      Oviedo , Spain

      Cambridge , United Kingdom

      Leeds , United Kingdom

      Leicester , United Kingdom

      London , United Kingdom

      London , United Kingdom

      Manchester , United Kingdom

      Middlesborough , United Kingdom

      Newcastle-upon-Tyne , United Kingdom

      Portsmouth , United Kingdom

      Taunton , United Kingdom

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In this clinical trial, patients will take one of the following treatments based on the randomization:

      Experimental Arm:

      1. Volrustomig in combination with carboplatin plus pemetrexed

      Active Comparator Arm: Depending on the patient’s histology type:

      1. If the patient has epithelioid histology, they may receive the investigator’s choice of nivolumab plus ipilimumab or platinum plus pemetrexed chemotherapy.
      2. For patients with non-epithelioid histology, the treatment will be nivolumab plus ipilimumab.

      These treatments are part of a randomized, open-label, Phase III trial, and the specific medication regimen to be taken will be assigned using Interactive Response Technology/Randomization and Trial Supply Management.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have the following disease as per the inclusion criteria:

      Pleural mesothelioma with known histology (either epithelioid or non-epithelioid).


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here is the list of conditions you must meet to join the study along with explanations of the medical terms:

      1. Age: You must be 18 years or older at the time of screening.
      2. Diagnosis: You must have a histologically proven diagnosis of pleural mesothelioma. This means that your diagnosis has been confirmed by microscopic examination of tissue samples, showing whether the cells are of the epithelioid (cells resemble normal epithelial cells) or non-epithelioid type.
      3. Stage of Disease: You must have advanced unresectable disease, which means that the cancer has progressed to a stage where it cannot be removed entirely by surgery and is not considered curable, with or without the use of chemotherapy.
      4. Performance Status: You must have a WHO/ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to the first day of dosing. The World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status is a scale that measures your ability to perform ordinary tasks and care for yourself, where:
        • 0 indicates you are fully active and able to carry on with all pre-disease performance without restriction.
        • 1 indicates you are restricted in physically strenuous activity but can still carry out light work.
      5. Measurable Disease: You must have measurable disease per the modified RECIST 1.1 criteria. Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 is a set of published rules that define when cancer patients improve (“respond”), stay the same (“stable”), or worsen (“progress”) during treatment. The term “measurable disease” refers to cancer that can be accurately measured in size.
      6. Organ Function: You must have adequate bone marrow reserve and organ function at baseline. This means that your bone marrow must be functioning adequately to produce blood cells, and your organs (e.g., liver, kidneys, heart) must be working well enough to tolerate the treatment.

      I hope this helps to clarify the criteria for participating in the study. If you need further information or have other questions, feel free to ask.

      What Reasons Could Exclude Me from the Study?

      Here is a list of conditions that would make you ineligible to participate in the study along with the explanations of some medical terms:

      1. Active or prior documented autoimmune or inflammatory disorders: This refers to conditions where the immune system attacks the body (like lupus or rheumatoid arthritis) or causes inflammation (like Crohn’s disease).
      2. History of another primary malignancy: A past diagnosis of cancer that is not the type being studied in this trial unless specified exceptions apply.
      3. Uncontrolled intercurrent illness: A simultaneous disease or condition that is not being effectively managed or treated.
      4. Tuberculosis (TB): An infectious bacterial disease that mainly affects the lungs.
      5. Hepatitis B (HBV) or Hepatitis C (HCV): Viral infections that affect the liver.
      6. Human immunodeficiency virus (HIV) infection that is not well controlled: A virus that attacks the immune system, and if it’s not well-managed, it can lead to Acquired Immunodeficiency Syndrome (AIDS).
      7. Concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment: Receiving other treatments for cancer at the same time as the trial treatments.
      8. Untreated or progressive Central Nervous System (CNS) metastatic disease: Cancer that has spread to the brain or spinal cord that has not been treated or is getting worse.

      Let me know if you need further clarifications on any of these points.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study along with a brief description of each active substance are as follows:

      1. Volrustomig (MEDI5752): Administered as an intravenous (IV) infusion. It is an immuno-oncology agent that targets the CD73 pathway, enhancing the immune system’s ability to recognize and attack cancer cells.
      2. Pemetrexed (Alimta): Administered as an IV infusion. It is an antifolate chemotherapy agent that disrupts folate-dependent metabolic processes essential for cell replication.
      3. Carboplatin (Paraplatin): Administered as an IV infusion. It is a chemotherapy medication used to treat various forms of cancer; it works by causing DNA damage, which ultimately kills the cancer cells.
      4. Cisplatin (Platinol): Administered as an IV infusion. Similar to carboplatin, it is a platinum-based drug that causes DNA cross-linking and damage, leading to apoptosis (cell death) of cancer cells.
      5. Nivolumab (Opdivo): Administered as an IV infusion. It is a programmed death-1 (PD-1) immune checkpoint inhibitor that helps the immune system recognize and respond to cancer cells.
      6. Ipilimumab (Yervoy): Administered as an IV infusion. It is a cytotoxic T-lymphocyte antigen-4 (CTLA-4) inhibitor that stimulates the immune system to fight against cancer cells.

      These drugs are being investigated for their efficacy and safety in participants with unresectable pleural mesothelioma.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial includes the following active substances, all of which are known to medicine and the medical literature:

      1. Carboplatin: An antineoplastic agent used in the treatment of various cancers. It is a platinum-containing chemotherapy drug that causes crosslinking of DNA, leading to apoptosis of cancer cells.
      2. Nivolumab: An immune checkpoint inhibitor that is classified under antineoplastic agents, immunological. It functions by blocking a protein called PD-1 on the surface of immune cells, which can increase the immune response against cancer cells.
      3. Pemetrexed: This substance is a folic acid antagonist used as an antineoplastic agent. It inhibits nucleic acid synthesis and is commonly used in the treatment of malignant pleural mesothelioma and non-squamous non-small cell lung cancer.
      4. Ipilimumab: An immune checkpoint inhibitor that works by activating the immune system to attack cancer cells. It targets CTLA-4, a protein receptor that downregulates the immune system.

      These substances are part of a class of medications aimed at treating cancer by interfering with cell growth or by enhancing the immune response to cancer cells.


      Study ID

      CT-EU-00033164

      Recruitment status

      Recruting new patients

      Start of the trial

      8 months ago