Study on Atezolizumab for Patients with Malignant Pleural Mesothelioma After Surgery

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What is this study about?

This clinical trial is focused on studying a disease called Malignant Pleural Mesothelioma, which is a type of cancer that affects the lining of the lungs. The study is investigating the effects of a treatment called Atezolizumab, also known by its code name MPDL3280A. Atezolizumab is a medication given through an intravenous infusion, which means it is administered directly into the bloodstream through a vein. The trial will compare the effects of Atezolizumab to a placebo in patients who have undergone a surgical procedure called pleurectomy/decortication, which involves removing part of the lining of the lungs.

The purpose of this study is to evaluate how effective Atezolizumab is in preventing the return of the disease after surgery. Participants in the study will receive either Atezolizumab or a placebo and will be monitored over a period of time to see how their disease progresses. The study will look at how long it takes for the disease to come back or for the patient to pass away from any cause. This is known as disease-free survival. Additionally, the study will monitor any side effects that occur during the treatment.

Throughout the study, participants will be regularly assessed by healthcare professionals to track their health and any changes in their condition. The study aims to provide valuable information on the potential benefits of Atezolizumab for patients with Malignant Pleural Mesothelioma, which could lead to improved treatment options in the future.

1 joining the study

Participation begins after meeting specific criteria, including being 18 years or older, having a confirmed diagnosis of malignant pleural mesothelioma, and undergoing surgical resection without visible residual disease.

Patients must have completed at least four cycles of chemotherapy with platinum and pemetrexed, unless fewer cycles were decided for clinical reasons.

Randomization occurs within 50 days after surgery for those who had chemotherapy before surgery, or within 30 days after the last dose of chemotherapy for those who had it after surgery.

2 treatment administration

The treatment involves receiving either atezolizumab or a placebo through an intravenous route.

The specific dosage and frequency of administration are determined by the study protocol and are not detailed here.

3 monitoring and evaluation

The primary goal is to assess the time from the start of treatment to the first recurrence of the disease or death, known as disease-free survival (DFS).

Regular evaluations are conducted to monitor the disease status using specific criteria.

4 safety and side effects

The study tracks the occurrence, nature, and severity of any side effects related to the treatment.

These are categorized according to established criteria for adverse events.

5 quality of life assessment

Participants may be asked to complete a questionnaire to evaluate their quality of life during the study.

6 study duration

The study is expected to conclude by December 13, 2027.

Who Can Join the Study?

Must be 18 years or older on the day of signing the consent form.
Must have a confirmed diagnosis of malignant pleural mesothelioma, which is a type of cancer affecting the lining of the lungs.
Must have had a surgical procedure called pleurectomy/decortication (P/D) to remove the tumor, with no visible cancer left. For patients in early stages without deeper organ involvement, a complete removal of the pleura (lining of the lung) is allowed.
Must have received at least 4 cycles of chemotherapy with drugs called platinum and pemetrexed, which are used to treat cancer. Fewer than 4 cycles are allowed if decided by the doctor.
If treated with chemotherapy before surgery, must join the study within 50 days after surgery.
If treated with chemotherapy after surgery, must join the study within 30 days (plus or minus 7 days) after the last chemotherapy dose.
Must have a performance status of 0-1 on the ECOG Performance Scale, which means being fully active or having some symptoms but still able to do light work.
Must have adequate organ function, confirmed by lab tests done within 14 days before starting treatment.
Must provide one tumor sample from the initial diagnosis for study purposes.

Who Cannot Join the Study?

Patients who do not have malignant pleural mesothelioma, which is a type of cancer affecting the lining of the lungs, cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
Patients who are part of a vulnerable population, meaning they may have additional risks or need special protection, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Ospedale S G Moscati	Statte	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Ospedale Villa Scassi – Sampierdarena-ASL3-Azienda sociosanitaria ligure	Genoa	Italy
Arqvfkh Obdiudoekvv Urbkyhyzofdjl Pjtgb	Parma	Italy
Ajefzz Ajqgzco Bqpxuf e Ctmnvr Akemwv Avyezfxerrd	Alexandria	Italy
Ivhuhqau Rmxaazgoo Pva Lt Swthlb Daz Twyrrl Djfu Afdijso Iqqh Sudjqt	Meldola	Italy
Acnappm Ucr Idedh Dk Rqgfua Edywyj	Reggio Emilia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	13.12.2021

Trial locations

Investigated drugs:

Atezolizumab

Atezolizumab is a medication used in this clinical trial to treat patients with malignant pleural mesothelioma, a type of cancer that affects the lining of the lungs. It works by helping the immune system recognize and attack cancer cells. This study aims to determine how effective atezolizumab is in preventing the cancer from returning after surgery.

Investigated diseases:

Pleural mesothelioma malignant

Malignant Pleural Mesothelioma – This is a rare type of cancer that affects the lining of the lungs, known as the pleura. It is primarily caused by exposure to asbestos fibers, which can lead to the development of cancerous cells in the pleura. The disease often begins with symptoms such as chest pain, shortness of breath, and fluid buildup around the lungs. As it progresses, it can cause more severe respiratory issues and discomfort. The cancer cells can spread to other parts of the body, complicating the condition further. The progression of the disease can vary, but it typically involves a gradual worsening of symptoms over time.

Trial ID:

2024-519286-21-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Atezolizumab for Patients with Malignant Pleural Mesothelioma After Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?