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

NCT ID: NCT04775446

Last Updated: 2022-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-26

Study Completion Date

2021-10-11

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.

Conditions

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Malignant Pleural Mesothelioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients with malignant pleural mesothelioma treated with Nivolumab.

Patients with malignant pleural mesothelioma treated with Nivolumab.

Data collection

Intervention Type OTHER

Data entered in a secure computer database

Interventions

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Data collection

Data entered in a secure computer database

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CH Côte basque

Bayonne, , France

Site Status

CHU Brest

Brest, , France

Site Status

CH Cherbourg

Cherbourg, , France

Site Status

CHI Créteil

Créteil, , France

Site Status

CHU Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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MESOIMMUNE

Identifier Type: -

Identifier Source: org_study_id

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