Study on Nivolumab and MesoPher for Patients with Peritoneal Mesothelioma

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ecombvh Ucooytrimyst Mrpdwra Cjxkjeu Rmnsfdnrj (hsnfoav Mug	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.02.2025

Trial locations

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.

Investigated diseases:

Peritoneal mesothelioma malignant

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 ID:

2024-519626-21-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Nivolumab and MesoPher for Patients with Peritoneal Mesothelioma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?