Observational Study in Patients With Previously Unresectable Malignant Pleural Mesothelioma Treated With Nivolumab and Ipilimumab (MESO-IMMUNE) (MESO-IMMUNE)

Primary Outcome Measures

1. Progression Free Survival assessed locally [ Time Frame: time from first dose of combination Nivolumab-Ipilimumab to first documentation of disease progression or to death from any cause evaluated through the total duration of the study (up to 48 months) ]

Secondary Outcome Measures

1. Potential professional exposure(s) [ Time Frame: At Baseline ]
   Unresectable Malignant Pleural Mesothelioma Patients’ characteristics based on data collected from the patient medical notes. Qualitative parameters will be expressed as numbers, percentages and 95% confidence intervals.
2. Eastern Cooperative Oncology Group performance status (PS) [ Time Frame: At Baseline ]
   Unresectable Malignant Pleural Mesothelioma Patients’ characteristics based on data collected from the patient medical notes. Quantitative parameters will be expressed as means, standard deviations or medians and interquartile ranges.
3. Body weight [ Time Frame: At Baseline ]
   Unresectable Malignant Pleural Mesothelioma Patients’ characteristics based on data collected from the patient medical notes expressed in kilograms. Quantitative parameters will be expressed as means, standard deviations or medians and interquartile ranges.
4. Body mass index (BMI) [ Time Frame: At Baseline ]
   Unresectable Malignant Pleural Mesothelioma Patients’ characteristics based on data collected from the patient medical notes. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m 2, resulting from mass in kilograms and height in metres. Quantitative parameters will be expressed as means, standard deviations or medians and interquartile ranges.
5. Smoking status [ Time Frame: At Baseline ]
   Unresectable Malignant Pleural Mesothelioma Patients’ characteristics based on data collected from the patient medical notes. Qualitative parameters will be expressed as numbers, percentages and 95% confidence intervals.
6. Medical history [ Time Frame: At Baseline ]
   Unresectable Malignant Pleural Mesothelioma Patients’ characteristics based on data collected from the patient medical notes. Qualitative parameters will be expressed as numbers, percentages and 95% confidence intervals.
7. Comorbidities [ Time Frame: At Baseline ]
   Unresectable Malignant Pleural Mesothelioma Patients’ characteristics based on data collected from the patient medical notes. Qualitative parameters will be expressed as numbers, percentages and 95% confidence intervals.
8. Past history of cancer or auto-immune disease [ Time Frame: At Baseline ]
   Unresectable Malignant Pleural Mesothelioma Patients’ characteristics based on data collected from the patient medical notes. Qualitative parameters will be expressed as numbers, percentages and 95% confidence intervals.
9. Overall Survival (OS) [ Time Frame: From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months) ]
   OS defined as the time from first treatment start to death for any cause expressed in months
10. Objective Response Rate (ORR) [ Time Frame: From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months) ]
    Objective Response Rate (ORR): best overall response of complete response (CR) or partial response (PR) to a first line of treatment using i-RECIST criteria as assessed locally
11. Safety of combination Nivolumab-Ipilimumab [ Time Frame: From first dose of combination Nivolumab-Ipilimumab up to 100 days after the last treatment dose administration, up to 48 months (study duration) ]
    Data on adverse events (AEs) will be collected, and relatedness of these events to the use of drugs associated with this study (where applicable) will be assessed.
12. Treatment duration [ Time Frame: From first dose of combination Nivolumab-Ipilimumab to the end of treatment, up to 48 months (study duration) ]
    Time to treatment failure, defined as the time from the first dose of combination Nivolumab-Ipilimumab to disease progression locally assessed, death, non-objection withdrawn, adverse event, lost to follow-up or initiation of another anticancer treatment.
13. Reasons for treatment discontinuation [ Time Frame: From first dose of combination Nivolumab-Ipilimumab to the end of treatment, up to 48 months (study duration) ]
    Reasons for treatment discontinuation will be collected and recorded in the e-CRF
14. Post-progression treatments [ Time Frame: From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months) ]
    The name, start and end date, of treatments initiated after the disease progression of the patient will be collected and recorded in the e-CRF. Date of progression for these treatments will be reported as well.
15. Treatment outcome in terms of PFS in subgroups of patients according to patient’s characteristics: elderly patients (age >80 years old), patients with performance status >1, patients with comorbidities [ Time Frame: From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months) ]
    Treatment outcome in terms of progression free survival as assessed by the investigator, defined as the time from first dose of combination Nivolumab-Ipilimumab to first documentation of disease progression or to death from any cause, whichever came first
16. Treatment outcomes in terms of AEs in subgroups of patients according to patient’s characteristics: elderly patients (age >80 years old), patients with performance status >1, patients with comorbidities [ Time Frame: From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months) ]
    Treatment outcome in terms of proportion (%) of patients with any adverse event (AE) and number and severity of events per subgroup of patients

Inclusion Criteria

• Patient with previously untreated and unresectable Malignant Pleural Mesothelioma treated with combination Nivolumab and Ipilimumab in the setting of the early access program
• Patient enrolled in the French National Health Insurance program or with a third-party payer
• Patient not opposed to the collection of his/her data (an information sheet will be to all living patients; for those who died, documented opposition to data collection in his/her medical file is not required)

Exclusion Criteria

• Patient under curatorship or guardianship
• Patient’s explicit refusal to collect his / her data
• Patients not managed at the investigating center and not followed by a center investigator