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

Groupe Francais De Pneumo-Cancerologie

Status: Active, not recruiting

Conditions: Malignant Pleural Mesothelioma; Unresectable Malignant Neoplasm

Treatments: Other: Data collection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05308966

GFPC 04-2021

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Patient presenting MPS treated with nivolumab and ipilimumab

Description:

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

Treatment:

Other: Data collection