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

Malignant Pleural Mesothelioma Clinical Trial

— MESOIMMUNE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04775446
• Other study ID #: MESOIMMUNE
• Status: Completed
• Start date: November 26, 2020
• Est. completion date: October 11, 2021

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: October 11, 2021
• Est. primary completion date: October 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Mesothelioma
• Mesothelioma
• Mesothelioma, Malignant

Intervention

Other:
• Data collection
Data entered in a secure computer database

Locations

Country	Name	City	State
France	CH Côte basque	Bayonne
France	CHU Brest	Brest
France	CH Cherbourg	Cherbourg
France	CHI Créteil	Créteil
France	CHU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control	Disease control rate at 12 weeks	12 weeks
Secondary	Survival with anti-PD1/PDL1 immunotherapy	Overall survival from treatment with anti-PD1/PDL1 immunotherapy	12 weeks
Secondary	Duration of treatment	Duration of treatment with PD1/PDL1 immunotherapy	12 weeks
Secondary	Survival	Overall survival from the start of the first treatment	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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