Study on Adding Atezolizumab and WT1/DC Vaccine to Standard Treatment for Patients with Epithelioid Malignant Pleural Mesothelioma

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What is this study about?

This clinical trial is focused on studying a type of cancer called epithelioid malignant pleural mesothelioma, which affects the lining of the lungs. The study is exploring the use of a treatment combination that includes a medication called atezolizumab and a vaccine known as WT1/DC. Atezolizumab is a type of drug that helps the immune system fight cancer, and it is also known by its code name RO5541267. The WT1/DC vaccine is designed to stimulate the body’s immune response against cancer cells. These treatments are being added to the standard chemotherapy regimen, which includes drugs like platinum and pemetrexed.

The purpose of the study is to investigate how safe and feasible it is to add atezolizumab and WT1/DC vaccination to the usual chemotherapy for patients with this type of cancer. Participants in the study will receive a series of treatments over a period of time. This includes four cycles of chemotherapy combined with four treatments of atezolizumab and four vaccinations with WT1/DC. The study will monitor the safety of these treatments by observing any side effects that may occur during the treatment period and follow-up.

In addition to safety, the study will also look at how effective the treatment is in controlling the cancer. This includes measuring how well the cancer responds to the treatment, how long the response lasts, and the overall survival of the participants. The study will also assess the immune response generated by the WT1/DC vaccine. The trial is expected to continue until 2027, providing valuable information on the potential benefits and risks of this new treatment approach for patients with epithelioid malignant pleural mesothelioma.

1 joining the study

Upon joining the study, the patient must have signed an informed consent form. This indicates understanding and agreement to participate in the trial.

The patient must have a confirmed diagnosis of epithelioid malignant pleural mesothelioma, which is a type of cancer affecting the lining of the lungs.

2 initial assessment

An initial assessment is conducted to ensure the patient meets all eligibility criteria, including age, health status, and negative viral serology for certain infections.

Women of childbearing potential must undergo a pregnancy test to confirm they are not pregnant.

3 treatment phase

The treatment phase involves a combination of chemotherapy and immunotherapy.

The patient receives four cycles of platinum/pemetrexed-based chemotherapy. This is a standard treatment for mesothelioma.

Alongside chemotherapy, the patient receives four doses of atezolizumab, a medication given through an intravenous infusion. Atezolizumab is an immunotherapy drug that helps the immune system fight cancer.

The patient also receives four WT1 LAMP mRNA DC vaccinations. These are given through intradermal injections and are designed to stimulate the immune system to target cancer cells.

4 monitoring and follow-up

Throughout the treatment, the patient is monitored for any side effects or adverse events. This ensures the safety and well-being of the patient.

Regular follow-up appointments are scheduled to assess the effectiveness of the treatment and to monitor the patient’s health status.

5 completion of study

The study aims to determine the feasibility and safety of the treatment combination. The primary goal is to see how many patients can complete the treatment schedule.

Secondary goals include evaluating the treatment’s effectiveness in controlling the disease and improving survival rates.

Who Can Join the Study?

You must have signed an informed consent form, which means you agree to participate in the study after understanding what it involves.
You need to have a confirmed diagnosis of epithelioid malignant pleural mesothelioma (MPM), which is a type of cancer affecting the lining of the lungs, and it should be at any stage from I to IV.
You must be 18 years or older at the time you sign the informed consent form.
Your performance status should be grade 0-1 according to the World Health Organization (WHO), meaning you are fully active or have some restrictions but can still carry out light work.
You should have adequate hematologic and end-organ function, which means your blood and major organs like the liver and kidneys are working well enough.
You must test negative for certain viruses, specifically Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV).
You should be willing and able to follow the study protocol, as determined by your doctor.
If you are a woman who can have children, you must have a negative pregnancy test at the time of screening.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have received certain treatments that might interfere with the study.
Patients with serious health conditions that could make participation unsafe.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures for any reason.
Patients who have allergies to the study medications.
Patients who are participating in another clinical trial.
Patients who have had a recent major surgery.
Patients with a history of certain infections that could affect the study.
Patients who have a history of drug or alcohol abuse.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Az Maria Middelares Gent	Gent	Belgium
Vitaz	Sint-Niklaas	Belgium
Uhyfzjhtuu Oo Ajjklqp	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	24.02.2023

Trial locations

Investigated drugs:

Atezolizumab is a medication used in this trial to help the immune system fight cancer cells. It works by blocking a protein that can stop the immune system from attacking cancer cells, allowing the immune system to better target and destroy them.

WT1/DC Vaccination is a type of cancer vaccine used in the trial. It is designed to stimulate the immune system to recognize and attack cancer cells that express a specific protein called WT1, which is often found in certain types of cancer.

Platinum-based Chemotherapy is a standard treatment for various cancers, including mesothelioma. It involves using drugs that contain the metal platinum to damage the DNA of cancer cells, which can stop them from growing and dividing.

Pemetrexed is a chemotherapy drug used in combination with platinum-based chemotherapy. It works by interfering with the cancer cell’s ability to use folate, a vitamin that is necessary for cell division, thereby slowing or stopping the growth of cancer cells.

Investigated diseases:

Pleural mesothelioma malignant

Malignant pleural mesothelioma, epithelioid subtype – This is a rare cancer that affects the lining of the lungs, known as the pleura. It is primarily associated with exposure to asbestos fibers. The epithelioid subtype is the most common form of mesothelioma and tends to grow more slowly than other subtypes. The disease progresses as cancer cells multiply and form tumors, which can spread to nearby tissues and organs. Symptoms often include chest pain, shortness of breath, and fluid buildup around the lungs. As the disease advances, it can lead to more severe respiratory issues and discomfort.

Trial ID:

2024-515293-27-00

Protocol code:

Immuno-MESODEC

NCT ID:

NCT05765084

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Adding Atezolizumab and WT1/DC Vaccine to Standard Treatment for Patients with Epithelioid Malignant Pleural Mesothelioma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?