Clinical trial NCT05308966: Observational Study in Patients With Previously Unresectable Malignant Pleural Mesothelioma Treated With Nivolumab and Ipilimumab (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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Malignant Pleural Mesothelioma
Unresectable Malignant Neoplasm
Keywords: Mesothelioma
Lead sponsor: Groupe Francais De Pneumo-Cancerologie
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2022-04-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with previously untreated and unresectable Malignant Pleural Mesothelioma treated with combination Nivolumab and Ipilimumab in the setting of the early access program not opposed to the collection of his/her data

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival assessed locally
timeFrame: 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 outcomes:
measure: Potential professional exposure(s)
timeFrame: At Baseline
measure: Eastern Cooperative Oncology Group performance status (PS)
timeFrame: At Baseline
measure: Body weight
timeFrame: At Baseline
measure: Body mass index (BMI)
timeFrame: At Baseline
measure: Smoking status
timeFrame: At Baseline
measure: Medical history
timeFrame: At Baseline
measure: Comorbidities
timeFrame: At Baseline
measure: Past history of cancer or auto-immune disease
timeFrame: At Baseline
measure: Overall Survival (OS)
timeFrame: From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months)
measure: Objective Response Rate (ORR)
timeFrame: From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months)
measure: Safety of combination Nivolumab-Ipilimumab
timeFrame: From first dose of combination Nivolumab-Ipilimumab up to 100 days after the last treatment dose administration, up to 48 months (study duration)
measure: Treatment duration
timeFrame: From first dose of combination Nivolumab-Ipilimumab to the end of treatment, up to 48 months (study duration)
measure: Reasons for treatment discontinuation
timeFrame: From first dose of combination Nivolumab-Ipilimumab to the end of treatment, up to 48 months (study duration)
measure: Post-progression treatments
timeFrame: From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months)
measure: 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
timeFrame: From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months)
measure: 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
timeFrame: From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months)
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: CHU du Pays d'Aix
city: Albi
country: France
facility: CH Albi
city: Angers
country: France
facility: CHU Angers
city: Argenteuil
country: France
facility: CH Argenteuil
city: Avignon
country: France
facility: CH Avignon
city: Bastia
country: France
facility: CH Bastia
city: Bayonne
country: France
facility: CH Bayonne
city: Besançon
country: France
facility: CHU Besançon
city: Beuvry
country: France
facility: Clinique Ambroise Paré
city: Bligny
country: France
facility: CH Bligny
city: Bordeaux
country: France
facility: Clinique Bordeaux
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Brest
country: France
facility: CHU Morvan
city: Brest
country: France
facility: Clinique Pasteur
city: Bron
country: France
facility: Hôpital Louis Pradel
city: Caen
country: France
facility: CHU Caen
city: Cannes
country: France
facility: CH Cannes
city: Cherbourg
country: France
facility: CH du Cotentin
city: Clermont-Ferrand
country: France
facility: CHU Hôpital Montpied
city: Clermont-Ferrand
country: France
facility: Unicancer
city: Colmar
country: France
facility: Hôpital Louis Pasteur
city: Créteil
country: France
facility: Centre hospitalier Intercommunal
city: Dijon
country: France
facility: CH Dijon Bourgogne
city: Gentilly
country: France
facility: Clinique Gentilly
city: La Roche-sur-Yon
country: France
facility: CHD les Oudaries
city: Le Havre
country: France
facility: GH Le Havre
city: Le Mans
country: France
facility: CH du Mans
city: Libourne
country: France
facility: CH Libourne
city: Lille
country: France
facility: CHU Lille
city: Longjumeau
country: France
facility: CH de Longjumeau
city: Lorient
country: France
facility: Hôpital du Scorff
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: IPC
city: Marseille
country: France
facility: Hôpital Nord
city: Mougins
country: France
facility: CAC Mougins
city: Nevers
country: France
facility: CH Nevers
city: Nice
country: France
facility: Clinique Saint Georges
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital La Pitié-Salpêtrière
city: Paris
country: France
facility: GH Paris Site St Joseph
city: Pessac
country: France
facility: Hôpital Haut-Lévèque - Groupe Hospitalier SUD
city: Poitiers
country: France
facility: CHU La Mileterie
city: Pringy
country: France
facility: CH Annecy Genevois
city: Quimper
country: France
facility: CH Cornouaille
city: Rennes
country: France
facility: CHU Ponchailloux
city: Rennes
country: France
facility: Clinique Saint Grégoire
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Saint Malo
country: France
facility: CH de Saint Malo
city: Saint Mande
country: France
facility: HIA Begin
city: Saint-Herblain
country: France
facility: Insititut de Cancerologie de l'Ouest
city: Saint-Nazaire
country: France
facility: Clinique de l'Estuaire
city: Saint-Quentin
country: France
facility: CH St Quentin
city: Saint-Étienne
country: France
facility: Hôpital privé de la Loire
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
city: Toulon
country: France
facility: CHITS Toulon Sainte Musse
city: Toulon
country: France
facility: HIA St Anne
city: Toulouse
country: France
facility: Hôpital Larrey
city: Tours
country: France
facility: CHRU Bretonneau
city: Villefranche-sur-Saône
country: France
facility: CH Villefranche
city: Villeurbanne
country: France
facility: CH Villeurbanne
city: Évreux
country: France
facility: CH Eure-Seine
Study officials:
affiliation: Groupe Français de Pneumo-Cancérologie (GFPC)
name: Christos CHOUAID
role: STUDY_CHAIR
References: