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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Pleural Mesothelioma; Unresectable Malignant Neoplasm
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France, 13616
    • CHU du Pays d'Aix
  • Albi, France, 81013
    • CH Albi
  • Angers, France, 49033
    • CHU Angers
  • Argenteuil, France, 95010
    • CH Argenteuil
  • Avignon, France, 84000
    • CH Avignon
  • Bastia, France, 20200
    • CH Bastia
  • Bayonne, France, 64100
    • CH Bayonne
  • Besançon, France, 25000
    • Chu Besancon
  • Beuvry, France, 63660
    • Clinique Ambroise Paré
  • Bligny, France, 91640
    • CH Bligny
  • Bordeaux, France, 33000
    • Clinique Bordeaux
  • Boulogne-Billancourt, France, 92100
    • Hopital Ambroise Pare
  • Brest, France, 29200
    • Clinique Pasteur
  • Brest, France, 29200
    • Chu Morvan
  • Bron, France, 69500
    • Hopital Louis Pradel
  • Caen, France, 14033
    • CHU Caen
  • Cannes, France, 06400
    • CH Cannes
  • Cherbourg, France, 50102
    • CH du Cotentin
  • Clermont-Ferrand, France, 63000
    • CHU Hôpital Montpied
  • Clermont-Ferrand, France, 63000
    • UNICANCER
  • Colmar, France, 68000
    • Hopital Louis Pasteur
  • Créteil, France, 94010
    • Centre Hospitalier Intercommunal
  • Dijon, France, 21000
    • CH Dijon Bourgogne
  • Gentilly, France, 94250
    • Clinique Gentilly
  • La Roche-sur-Yon, France, 85000
    • CHD les Oudaries
  • Le Havre, France, 76083
    • GH Le Havre
  • Le Mans, France, 72000
    • CH du Mans
  • Libourne, France, 33500
    • CH Libourne
  • Lille, France, 59000
    • CHU Lille
  • Longjumeau, France, 91160
    • CH de Longjumeau
  • Lorient, France, 56100
    • Hôpital du Scorff
  • Lyon, France, 69373
    • Centre Léon Bérard
  • Marseille, France, 13915
    • Hopital Nord
  • Marseille, France, 13009
    • IPC
  • Mougins, France, 06250
    • CAC Mougins
  • Nevers, France, 58000
    • CH Nevers
  • Nice, France, 06000
    • Clinique Saint Georges
  • Nice, France, 06149
    • Centre Antoine LACASSAGNE
  • Paris, France, 75014
    • Hôpital Cochin
  • Paris, France, 75005
    • Institut Curie
  • Paris, France, 75018
    • Hôpital Bichat
  • Paris, France, 75651
    • Hôpital La Pitié-Salpétrière
  • Paris, France, 75674
    • GH Paris Site St Joseph
  • Pessac, France, 33604
    • Hôpital Haut-Lévèque - Groupe Hospitalier SUD
  • Poitiers, France, 86021
    • CHU La Mileterie
  • Pringy, France, 74374
    • Ch Annecy Genevois
  • Quimper, France, 02900
    • Ch Cornouaille
  • Rennes, France, 35000
    • CHU Ponchailloux
  • Rennes, France, 35000
    • Clinique Saint Grégoire
  • Rouen, France, 76031
    • Hopital Charles Nicolle
  • Saint Malo, France, 35400
    • CH de Saint Malo
  • Saint Mande, France, 94160
    • HIA Begin
  • Saint-Herblain, France, 44805
    • Insititut de Cancerologie de l'Ouest
  • Saint-Nazaire, France, 44600
    • Clinique de l'Estuaire
  • Saint-Quentin, France, 02321
    • CH St Quentin
  • Saint-Étienne, France, 42100
    • Hôpital Privé de la Loire
  • Strasbourg, France, 76091
    • Les Hopitaux Universitaires De Strasbourg
  • Toulon, France, 83056
    • CHITS Toulon Sainte Musse
  • Toulon, France, 83800
    • HIA St Anne
  • Toulouse, France, 31059
    • Hopital Larrey
  • Tours, France, 37044
    • CHRU Bretonneau
  • Villefranche-sur-Saône, France, 69400
    • CH Villefranche
  • Villeurbanne, France, 69100
    • CH Villeurbanne
  • Évreux, France, 27015
    • CH Eure-Seine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient presenting MPS treated with nivolumab and ipilimumab; 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	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Groupe Français de Pneumo-Cancérologie
• Collaborators: Bristol-Myers Squibb
• Investigators: Study Chair: Christos CHOUAID, Groupe Français de Pneumo-Cancérologie (GFPC)

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Mesothelioma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Neoplasms; Mesothelioma; Mesothelioma, Malignant
• Other Study ID Numbers: GFPC 04-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No