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

Study Overview
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Brief Summary
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Meso-Immune is a retrospective study to assess the efficacy and safety of the combination of Nivolumab and Ipilimumab used in first-line treatment of adult patients with unresectable Malignant Pleural Mesothelioma (MPM). This combination of treatments has been approved in Europe since June 2021 based on the results of the CheckMate 743 study. In France, the combination is not yet reimbursed for this population of patients. However, since April 01, 2021, newly diagnosed unresectable MPM patients may be treated with this combination via an early access program. Meso-Immune study targets these patients included in the early access program with the objective to provide additional results to the CheckMate 743 study and confirm the benefit of using this combination in first-line of treatment in this category of patients. Total study duration will cover 48 months with an inclusion period of 12 months and a follow-up until 3 years. Patients will be recruited retrospectively starting April 01, 2021 until April 01, 2022. Meso-Immune study will be proposed to all the GFPC centers that have already included patients in the early access program and other centers wishing to participate, in order to analyze a minimum of 150 patients. The total number of sites is evaluated at around 120. The principal investigator in each center will identify the patients eligible for the Meso-Immune study and will inform them on the study according to the local regulations. Patient follow-up will be pursued regularly, in in-patient and out-patient clinics, according to the usual practices of the physicians in each participating center. Reevaluation workups will be pursued according to the practices of each center. The information related to Patient characteristics, MPM characteristics, Treatment characteristics, Disease progression, Rebiopsy, Post treatments, Adverse events, Date and cause of death, Date of last news will be recorded in electronic case-report forms (eCRF). Qualitative variables will be presented descriptively in the principal analysis.

Official Title
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Multicenter Observational Retrospective French Study in Patients With Previously Untreated, Unresectable Malignant Pleural Mesothelioma Treated With Nivolumab and Ipilimumab Via an Early Access Program

Conditions
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Malignant Pleural Mesothelioma, Unresectable Malignant Neoplasm

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient presenting MPS treated with nivolumab and ipilimumab<br>Adult patients with previously untreated and unresectable Malignant Pleural Mesothelioma (MPM) treated with combination of Nivolumab and Ipilimumab in the setting of the early access program not opposed to the collection of their data | Other: Data collection<br>* Observational study without intervention except retrospective and prospective data collection : Patient characteristics, MPM characteristics, Treatment characteristics, Disease progression, Rebiopsy, Post treatments, Adverse events, Date and cause of death, Date of last news ; recorded in electronic case-report forms (eCRF).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival assessed locally | 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 | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential professional exposure(s) | 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. | At Baseline | 
| Eastern Cooperative Oncology Group performance status (PS) | 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. | At Baseline | 
| Body weight | 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. | At Baseline | 
| Body mass index (BMI) | 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. | At Baseline | 
| Smoking status | 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. | At Baseline | 
| Medical history | 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. | At Baseline | 
| Comorbidities | 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. | At Baseline | 
| Past history of cancer or auto-immune disease | 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. | At Baseline | 
| Overall Survival (OS) | OS defined as the time from first treatment start to death for any cause expressed in months | From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months) | 
| Objective Response Rate (ORR) | 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 | From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months) | 
| Safety of combination Nivolumab-Ipilimumab | 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. | From first dose of combination Nivolumab-Ipilimumab up to 100 days after the last treatment dose administration, up to 48 months (study duration) | 
| Treatment 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. | From first dose of combination Nivolumab-Ipilimumab to the end of treatment, up to 48 months (study duration) | 
| Reasons for treatment discontinuation | Reasons for treatment discontinuation will be collected and recorded in the e-CRF | From first dose of combination Nivolumab-Ipilimumab to the end of treatment, up to 48 months (study duration) | 
| Post-progression treatments | 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. | From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months) | 
| 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 | 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 | From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months) | 
| 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 | Treatment outcome in terms of proportion (%) of patients with any adverse event (AE) and number and severity of events per subgroup of patients | From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesothelioma