Multicentre Observational Study Evaluating the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy, in Real Life Setting.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malignant Pleural Mesothelioma
- Sponsor
- Centre Hospitalier Intercommunal Creteil
- Enrollment
- 116
- Locations
- 5
- Primary Endpoint
- Disease control
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Disease control
Time Frame: 12 weeks
Disease control rate at 12 weeks
Secondary Outcomes
- Survival with anti-PD1/PDL1 immunotherapy(12 weeks)
- Duration of treatment(12 weeks)
- Survival(12 weeks)
- Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by previous immunotherapy(12 weeks)
- Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by adverse event(12 weeks)
- Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by remarkable event(12 weeks)
- To identify factors predictive of treatment response by immunotherapy in responder patients(12 weeks)
- To identify factors predictive of the response of immunotherapy treatment of progressive patients(12 weeks)
- To identify factors predictive of the response of immunotherapy treatment of all patients(12 weeks)
- To identify factors predictive of the response of immunotherapy treatment according to follow-up treatment(12 weeks)