Observational Study in Patients With Previously Unresectable Malignant Pleural Mesothelioma Treated With Nivolumab and Ipilimumab (MESO-IMMUNE)
- Conditions
- Malignant Pleural MesotheliomaUnresectable Malignant Neoplasm
- Interventions
- Other: Data collection
- Registration Number
- NCT05308966
- Lead Sponsor
- Groupe Francais De Pneumo-Cancerologie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient presenting MPS treated with nivolumab and ipilimumab Data collection 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
- Primary Outcome Measures
Name Time Method Progression Free Survival assessed locally 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
- Secondary Outcome Measures
Name Time Method Potential professional exposure(s) 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.
Eastern Cooperative Oncology Group performance status (PS) 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.
Smoking status 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.
Comorbidities 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.
Past history of cancer or auto-immune disease 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.
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) 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
Body weight 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.
Body mass index (BMI) 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.
Medical history 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.
Overall Survival (OS) 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
Objective Response Rate (ORR) 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
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) 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.
Treatment duration 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.
Reasons for treatment discontinuation 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
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) Treatment outcome in terms of proportion (%) of patients with any adverse event (AE) and number and severity of events per subgroup of patients
Post-progression treatments 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.
Trial Locations
- Locations (64)
Hôpital Ambroise Paré
🇫🇷Boulogne-Billancourt, France
CHU Caen
🇫🇷Caen, France
CH Annecy Genevois
🇫🇷Pringy, France
CHU du Pays d'Aix
🇫🇷Aix-en-Provence, France
Clinique Ambroise Paré
🇫🇷Beuvry, France
Clinique Bordeaux
🇫🇷Bordeaux, France
CHU Morvan
🇫🇷Brest, France
CH du Cotentin
🇫🇷Cherbourg, France
CHU Hôpital Montpied
🇫🇷Clermont-Ferrand, France
CH Dijon Bourgogne
🇫🇷Dijon, France
GH Le Havre
🇫🇷Le Havre, France
Hôpital du Scorff
🇫🇷Lorient, France
CH de Saint Malo
🇫🇷Saint Malo, France
CH St Quentin
🇫🇷Saint-Quentin, France
CH Villefranche
🇫🇷Villefranche-sur-Saône, France
CH Villeurbanne
🇫🇷Villeurbanne, France
CH Eure-Seine
🇫🇷Évreux, France
Insititut de Cancerologie de l'Ouest
🇫🇷Saint-Herblain, France
Clinique de l'Estuaire
🇫🇷Saint-Nazaire, France
CHU Angers
🇫🇷Angers, France
CH Argenteuil
🇫🇷Argenteuil, France
Hôpital Louis Pradel
🇫🇷Bron, France
Unicancer
🇫🇷Clermont-Ferrand, France
Centre hospitalier Intercommunal
🇫🇷Créteil, France
Clinique Gentilly
🇫🇷Gentilly, France
Hôpital Cochin
🇫🇷Paris, France
CH Nevers
🇫🇷Nevers, France
Clinique Saint Georges
🇫🇷Nice, France
Hôpital Haut-Lévèque - Groupe Hospitalier SUD
🇫🇷Pessac, France
Hôpital Larrey
🇫🇷Toulouse, France
CH du Mans
🇫🇷Le Mans, France
CH Albi
🇫🇷Albi, France
CH Avignon
🇫🇷Avignon, France
CHU Besançon
🇫🇷Besançon, France
CH Bastia
🇫🇷Bastia, France
CH Bayonne
🇫🇷Bayonne, France
CH Bligny
🇫🇷Bligny, France
CH Cannes
🇫🇷Cannes, France
Clinique Pasteur
🇫🇷Brest, France
Hôpital Louis Pasteur
🇫🇷Colmar, France
CHD les Oudaries
🇫🇷La Roche-sur-Yon, France
Centre Léon Bérard
🇫🇷Lyon, France
CH Libourne
🇫🇷Libourne, France
CH de Longjumeau
🇫🇷Longjumeau, France
CHU Lille
🇫🇷Lille, France
CAC Mougins
🇫🇷Mougins, France
IPC
🇫🇷Marseille, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Institut Curie
🇫🇷Paris, France
Hôpital Nord
🇫🇷Marseille, France
Hôpital Bichat
🇫🇷Paris, France
Hôpital La Pitié-Salpêtrière
🇫🇷Paris, France
GH Paris Site St Joseph
🇫🇷Paris, France
CHU La Mileterie
🇫🇷Poitiers, France
CH Cornouaille
🇫🇷Quimper, France
Clinique Saint Grégoire
🇫🇷Rennes, France
CHU Ponchailloux
🇫🇷Rennes, France
Hôpital Charles Nicolle
🇫🇷Rouen, France
HIA Begin
🇫🇷Saint Mande, France
Hôpital privé de la Loire
🇫🇷Saint-Étienne, France
Les Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
HIA St Anne
🇫🇷Toulon, France
CHITS Toulon Sainte Musse
🇫🇷Toulon, France
CHRU Bretonneau
🇫🇷Tours, France