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Study on Nivolumab and MesoPher for Patients with Peritoneal 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 rare type of cancer called Peritoneal Mesothelioma, which affects the lining of the abdomen. The study will explore the effectiveness of a combination of treatments, including a medication called Nivolumab and a personalized cell therapy known as MesoPher. Nivolumab is a type of drug that helps the immune system fight cancer cells, while MesoPher involves using a patient's own immune cells that are specially prepared to target cancer cells.

The purpose of the study is to assess how well these treatments work when used together with a surgical procedure called Cytoreductive Surgery and a heated chemotherapy treatment known as Hyperthermic Intraperitoneal Chemotherapy (HIPEC). Participants in the study will receive these treatments over a period of time, with Nivolumab and MesoPher being administered before and after the surgery. The study will monitor the participants' health and the progression of the disease throughout the treatment period.

During the study, researchers will evaluate how the treatments affect the cancer and the immune system. They will look at how long participants live without the disease getting worse and will also check for any side effects. The study aims to provide valuable information on the potential benefits of combining these innovative treatments for patients with Peritoneal Mesothelioma.

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 visit and consent

    Upon joining the study, a detailed explanation of the trial will be provided. Written informed consent is required to participate.

    A negative pregnancy test is necessary for women of childbearing potential before starting the study.

  2. Step 2

    Treatment with nivolumab

    The first phase involves receiving nivolumab, a medication administered through an intravenous infusion. This is part of the neo-adjuvant treatment, which means it is given before the main treatment.

    The frequency and dosage will be determined by the study team based on individual needs.

  3. Step 3

    Dendritic cell therapy

    Following nivolumab, dendritic cell therapy (MesoPher) will be administered. This involves using personalized cells to help the immune system fight the disease.

    This therapy is also given through an intravenous infusion, with a total of up to five administrations, depending on availability.

  4. Step 4

    Surgery and chemotherapy

    The main treatment includes cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). This is a surgical procedure followed by heated chemotherapy applied directly to the abdominal area.

    This step is crucial for treating peritoneal mesothelioma and is performed according to the standard care procedures.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up visits are necessary to monitor health and response to treatment. This includes medical assessments and imaging tests like CT scans.

    The study team will evaluate the progression of the disease and any side effects experienced during the trial.

Who can join the trial?

7 criteria

  • Must have a diagnosis of epithelioid peritoneal mesothelioma, confirmed by a test called a histology.
  • Must be at least 18 years old and able to give written permission to participate in the study.
  • Must be healthy enough to undergo a procedure called CRS-HIPEC, which is a type of surgery and treatment for cancer.
  • Must be able to return to the study center for follow-up visits and vaccinations.
  • Must provide written permission to participate according to international guidelines for clinical trials.
  • Men must agree to use a reliable method of birth control during the study and for at least 12 months after the last dose of the study drug.
  • Women who can have children must have a negative pregnancy test before starting the study and agree to use a reliable method of birth control during the study and for at least 12 months after the last dose of the study drug.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides Peritoneal Mesothelioma cannot participate.
  • Patients who have had another cancer in the past, unless it was treated and has not come back for at least 5 years, are excluded.
  • Patients who are currently receiving any other cancer treatment are not eligible.
  • Patients with severe heart disease or uncontrolled high blood pressure cannot join the study.
  • Patients with active infections, including HIV, hepatitis B, or hepatitis C, are excluded.
  • Patients who have had an organ transplant cannot participate.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body, are not eligible.
  • Patients who are pregnant or breastfeeding cannot join the study.
  • Patients who are unable to follow the study procedures or attend the required visits are excluded.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible.
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Investigated drugs

  • Nivolumab

    is a type of medication known as a checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells. In this trial, it is used before and after surgery to help your body fight the cancer more effectively.

  • MesoPher

    is a form of dendritic cell therapy. Dendritic cells are a part of your immune system that help to start an immune response. This therapy involves using these cells to help your body recognize and attack cancer cells. It is used in combination with other treatments to improve the body's ability to fight the cancer.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating peritoneal mesothelioma, a type of cancer affecting the lining of the abdomen. Nivolumab works by blocking a specific protein on immune cells, which helps the body's immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that helps boost the immune response against cancer.

  • MesoPher

    MesoPher is a form of dendritic cell therapy, which involves using specialized immune cells to help the body fight cancer. It is administered through an injection, where these cells are introduced into the body to stimulate an immune response against peritoneal mesothelioma. MesoPher is currently being evaluated in clinical trials to determine its effectiveness when used alongside other treatments. The therapy works by enhancing the body's natural immune response to target and destroy cancer cells, and it falls under the category of immunotherapy, which uses the body's own defense system to combat disease.

Investigated diseases

Peritoneal Mesothelioma – Peritoneal Mesothelioma is a rare cancer that occurs in the thin layer of tissue lining the abdomen, known as the peritoneum. It is primarily caused by exposure to asbestos fibers, which can be inhaled or ingested and then become lodged in the abdominal lining. Over time, these fibers can cause inflammation and genetic changes in the cells, leading to the development of cancer. The disease typically progresses slowly, with symptoms often appearing decades after exposure. As it advances, it can cause abdominal pain, swelling, and fluid buildup, known as ascites. The progression of the disease can lead to further complications as the cancerous cells spread within the abdominal cavity.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519626-21-00Estimated enrolment18 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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