Clinical trial NCT04775446: Evaluation of the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Pleural Mesothelioma
Keywords: Immunotherapy
Pleura
Malignant Pleural Mesothelioma
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with malignant pleural mesothelioma treated with Nivolumab.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease control
timeFrame: 12 weeks
Secondary outcomes:
measure: Survival with anti-PD1/PDL1 immunotherapy
timeFrame: 12 weeks
measure: Duration of treatment
timeFrame: 12 weeks
measure: Survival
timeFrame: 12 weeks
measure: Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by previous immunotherapy
timeFrame: 12 weeks
measure: Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by adverse event
timeFrame: 12 weeks
measure: Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by remarkable event
timeFrame: 12 weeks
measure: To identify factors predictive of treatment response by immunotherapy in responder patients
timeFrame: 12 weeks
measure: To identify factors predictive of the response of immunotherapy treatment of progressive patients
timeFrame: 12 weeks
measure: To identify factors predictive of the response of immunotherapy treatment of all patients
timeFrame: 12 weeks
measure: To identify factors predictive of the response of immunotherapy treatment according to follow-up treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bayonne
country: France
facility: CH Côte basque
city: Brest
country: France
facility: CHU Brest
city: Cherbourg
country: France
facility: CH Cherbourg
city: Créteil
country: France
facility: CHI Créteil
city: Lille
country: France
facility: CHU Lille
Study officials:
References: