Multicenter Observational Retrospective French Study in Patients With Previously Untreated, Unresectable Malignant Pleural Mesothelioma Treated With Nivolumab and Ipilimumab Via an Early Access Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 63
- 主要终点
- Progression Free Survival assessed locally
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Progression Free Survival assessed locally
时间窗: 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)
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
次要结局
- Potential professional exposure(s)(At Baseline)
- Eastern Cooperative Oncology Group performance status (PS)(At Baseline)
- Smoking status(At Baseline)
- Comorbidities(At Baseline)
- Past history of cancer or auto-immune disease(At Baseline)
- 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(From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months))
- Body weight(At Baseline)
- Body mass index (BMI)(At Baseline)
- Medical history(At Baseline)
- Overall Survival (OS)(From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months))
- Objective Response Rate (ORR)(From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months))
- Safety of combination Nivolumab-Ipilimumab(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(From first dose of combination Nivolumab-Ipilimumab to the end of treatment, up to 48 months (study duration))
- Reasons for treatment discontinuation(From first dose of combination Nivolumab-Ipilimumab to the end of treatment, up to 48 months (study duration))
- 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(From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months))
- Post-progression treatments(From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months))