Evaluation of the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy

Study Overview
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Brief Summary
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The objective of this multicentre descriptive analysis is to describe the clinical and biological characteristics of patients who have received Programmed cell death 1 (anti-PD1) / (PDL1) Programmed death-ligand 1 (PDL1) immunotherapy outside of a clinical trial in terms of efficacy and safety.

Detailed Description
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Immunotherapy is now an option in the treatment of malignant pleural mesothelioma. A French study, Mesothelioma Avastin plus Pemetrexed-cisplatin Study 2 (MAPS 2), prospective in 2nd line or more, found 40% and 52% disease control rate with respectively an anti-PD1 antibody or a combo of anti-PD1 and Cytotoxic T-Lymphocyte-Associated protein 4 (anti-CTLA4). Safety was rather good with 14% and 26% grade 3-4 in the Nivolumab and combo group respectively. Thanks to this trial and data from the literature, Programmed cell death 1 (anti-PD1) / (PDL1) Programmed death-ligand 1 (PDL1) immunotherapy became an option in the treatment of malignant pleural mesothelioma, after validation by a multidisciplinary meeting. The objective of this multicentre descriptive analysis is to describe the clinical and biological characteristics of patients who have received anti-PD1/PDL1 immunotherapy outside of a clinical trial in terms of efficacy and safety.

Official Title
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Multicentre Observational Study Evaluating the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy, in Real Life Setting.

Conditions
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Malignant Pleural Mesothelioma

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over 18 years of age, Diagnosis of malignant pleural mesothelioma affirmed by the anatomo-pathological analysis report of a histological sample of the tumour (re-read by MESOPATH). Patient who has received at least one injection of anti-PD1 or anti-PDL1 antibodies Exclusion Criteria: Explicit refusal by the patient to collect data

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with malignant pleural mesothelioma treated with Nivolumab.<br>Patients with malignant pleural mesothelioma treated with Nivolumab. | Other: Data collection<br>* Data entered in a secure computer database<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control | Disease control rate at 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival with anti-PD1/PDL1 immunotherapy | Overall survival from treatment with anti-PD1/PDL1 immunotherapy | 12 weeks | 
| Duration of treatment | Duration of treatment with PD1/PDL1 immunotherapy | 12 weeks | 
| Survival | Overall survival from the start of the first treatment | 12 weeks | 
| Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by previous immunotherapy | Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: which immunotherapy, date of treatment beginning/end | 12 weeks | 
| Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by adverse event | Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: numbers of treatment related adverse events from CTCAE v4.0 | 12 weeks | 
| Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by remarkable event | Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: date of best response, date of progression, date of death) | 12 weeks | 
| To identify factors predictive of treatment response by immunotherapy in responder patients | Identify factors predictive of treatment response by immunotherapy in responder patients by collecting following data: Demographics data, treatment data, and blood test results and histological data | 12 weeks | 
| To identify factors predictive of the response of immunotherapy treatment of progressive patients | Identify factors predictive of treatment response by immunotherapy of progressive by collecting following data: Demographics data, treatment data, and blood test results and histological data | 12 weeks | 
| To identify factors predictive of the response of immunotherapy treatment of all patients | Identify factors predictive of treatment response by immunotherapy of all patients by collecting following data: Demographics data, treatment data, and blood test results and histological data | 12 weeks | 
| To identify factors predictive of the response of immunotherapy treatment according to follow-up treatment | Identify factors predictive of treatment response by immunotherapy according to type of treatment after PD1/PDL1 immunotherapy | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, Pleura, Malignant Pleural Mesothelioma