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

February 3, 2022 updated by: Centre Hospitalier Intercommunal Creteil

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bayonne, France
        • CH Côte Basque
      • Brest, France
        • CHU Brest
      • Cherbourg, France
        • CH Cherbourg
      • Créteil, France
        • CHI Créteil
      • Lille, France
        • CHU Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with malignant pleural mesothelioma treated with Nivolumab.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with malignant pleural mesothelioma treated with Nivolumab.
Other: Data collection
Data entered in a secure computer database

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control
Time Frame: 12 weeks
Disease control rate at 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival with anti-PD1/PDL1 immunotherapy
Time Frame: 12 weeks
Overall survival from treatment with anti-PD1/PDL1 immunotherapy
12 weeks
Duration of treatment
Time Frame: 12 weeks
Duration of treatment with PD1/PDL1 immunotherapy
12 weeks
Survival
Time Frame: 12 weeks
Overall survival from the start of the first treatment
12 weeks
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by previous immunotherapy
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 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
12 weeks
To identify factors predictive of the response of immunotherapy treatment of progressive patients
Time Frame: 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
12 weeks
To identify factors predictive of the response of immunotherapy treatment of all patients
Time Frame: 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
12 weeks
To identify factors predictive of the response of immunotherapy treatment according to follow-up treatment
Time Frame: 12 weeks
Identify factors predictive of treatment response by immunotherapy according to type of treatment after PD1/PDL1 immunotherapy
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 26, 2020

Primary Completion (ACTUAL)

October 11, 2021

Study Completion (ACTUAL)

October 11, 2021

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (ACTUAL)

March 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MESOIMMUNE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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