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

Completed

• Conditions: Malignant Pleural Mesothelioma
• Interventions: Other: Data collection

• Registration Number: NCT04775446
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-11-26
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-01
• Primary Completion: 2021-10-11
• Study Completion: 2021-10-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with malignant pleural mesothelioma treated with Nivolumab.	Data collection	Patients with malignant pleural mesothelioma treated with Nivolumab.

Primary Outcome Measures

Name	Time	Method
Disease control	12 weeks	Disease control rate at 12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (5)

CHU Brest; 🇫🇷 Brest, France

CH Cherbourg; 🇫🇷 Cherbourg, France

CHI Créteil; 🇫🇷 Créteil, France

CHU Lille; 🇫🇷 Lille, France

CH Côte basque; 🇫🇷 Bayonne, France