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

Malignant Pleural Mesothelioma Clinical Trial

— MESO-IMMUNE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05308966
• Other study ID #: GFPC 04-2021
• Status: Active, not recruiting
• Start date: May 3, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: October 2023
• Source: Groupe Francais De Pneumo-Cancerologie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Mesothelioma
• Mesothelioma
• Mesothelioma, Malignant
• Neoplasms
• Unresectable Malignant Neoplasm

Intervention

Other:
• Data collection
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).

Locations

Country	Name	City	State
France	CHU du Pays d'Aix	Aix-en-Provence
France	CH Albi	Albi
France	CHU Angers	Angers
France	CH Argenteuil	Argenteuil
France	CH Avignon	Avignon
France	CH Bastia	Bastia
France	CH Bayonne	Bayonne
France	CHU Besançon	Besançon
France	Clinique Ambroise Paré	Beuvry
France	CH Bligny	Bligny
France	Clinique Bordeaux	Bordeaux
France	Hôpital Ambroise Paré	Boulogne-Billancourt
France	CHU Morvan	Brest
France	Clinique Pasteur	Brest
France	Hôpital Louis Pradel	Bron
France	CHU Caen	Caen
France	CH Cannes	Cannes
France	CH du Cotentin	Cherbourg
France	CHU Hôpital Montpied	Clermont-Ferrand
France	Unicancer	Clermont-Ferrand
France	Hôpital Louis Pasteur	Colmar
France	Centre hospitalier Intercommunal	Créteil
France	CH Dijon Bourgogne	Dijon
France	CH Eure-Seine	Évreux
France	Clinique Gentilly	Gentilly
France	CHD les Oudaries	La Roche-sur-Yon
France	GH Le Havre	Le Havre
France	CH du Mans	Le Mans
France	CH Libourne	Libourne
France	CHU Lille	Lille
France	CH de Longjumeau	Longjumeau
France	Hôpital du Scorff	Lorient
France	Centre Léon Bérard	Lyon
France	Hôpital Nord	Marseille
France	IPC	Marseille
France	CAC Mougins	Mougins
France	CH Nevers	Nevers
France	Centre Antoine Lacassagne	Nice
France	Clinique Saint Georges	Nice
France	GH Paris Site St Joseph	Paris
France	Hôpital Bichat	Paris
France	Hôpital Cochin	Paris
France	Hôpital La Pitié-Salpêtrière	Paris
France	Institut Curie	Paris
France	Hôpital Haut-Lévèque - Groupe Hospitalier SUD	Pessac
France	CHU La Mileterie	Poitiers
France	CH Annecy Genevois	Pringy
France	CH Cornouaille	Quimper
France	CHU Ponchailloux	Rennes
France	Clinique Saint Grégoire	Rennes
France	Hôpital Charles Nicolle	Rouen
France	CH de Saint Malo	Saint Malo
France	HIA Begin	Saint Mande
France	Hôpital privé de la Loire	Saint-Étienne
France	Insititut de Cancerologie de l'Ouest	Saint-Herblain
France	Clinique de l'Estuaire	Saint-Nazaire
France	CH St Quentin	Saint-Quentin
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg
France	CHITS Toulon Sainte Musse	Toulon
France	HIA St Anne	Toulon
France	Hôpital Larrey	Toulouse
France	CHRU Bretonneau	Tours
France	CH Villefranche	Villefranche-sur-Saône
France	CH Villeurbanne	Villeurbanne

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Francais De Pneumo-Cancerologie	Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)