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

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ClinicalTrials.gov Identifier: NCT05308966
Recruitment Status : Not yet recruiting
First Posted : April 4, 2022
Last Update Posted : April 4, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Malignant Pleural Mesothelioma Unresectable Malignant Neoplasm Other: Data collection

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Estimated Study Start Date : April 30, 2022
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : May 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

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).




Primary Outcome Measures :
  1. Progression Free Survival assessed locally [ Time Frame: 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 :
  1. Potential professional exposure(s) [ Time Frame: 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.

  2. Eastern Cooperative Oncology Group performance status (PS) [ Time Frame: 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.

  3. Body weight [ Time Frame: 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.

  4. Body mass index (BMI) [ Time Frame: 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.

  5. Smoking status [ Time Frame: 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.

  6. Medical history [ Time Frame: 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.

  7. Comorbidities [ Time Frame: 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.

  8. Past history of cancer or auto-immune disease [ Time Frame: 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.

  9. Overall Survival (OS) [ Time Frame: 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

  10. Objective Response Rate (ORR) [ Time Frame: 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

  11. Safety of combination Nivolumab-Ipilimumab [ Time Frame: 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.

  12. Treatment duration [ Time Frame: 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.

  13. Reasons for treatment discontinuation [ Time Frame: 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

  14. Post-progression treatments [ Time Frame: 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.

  15. 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 [ Time Frame: 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

  16. 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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05308966


Contacts
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Contact: Laurent GRELLIER +33 4 91 96 59 01 Laurent.GREILLIER@ap-hm.fr
Contact: Olivier BYLICKI +33 4 83 16 27 39 bylicki.olivier@yahoo.fr

Locations
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France
CHU Morvan
Brest, France, 29200
Contact: Margaux Geier       margaux.geier@chu-brest.fr   
Centre hospitalier Intercommunal
Créteil, France, 94010
Contact: Isabelle Monnet       Isabelle.Monnet@chicreteil.fr   
Hôpital Nord
Marseille, France, 13915
Contact: Laurent Greillier       Laurent.GREILLIER@ap-hm.fr   
Hôpital Charles Nicolle
Rouen, France, 76031
Contact: Florian Guisier       florian.guisier@gmail.com   
HIA St Anne
Toulon, France, 83800
Contact: Olivier Bylicki       bylicki.olivier@yahoo.fr   
Sponsors and Collaborators
Groupe Francais De Pneumo-Cancerologie
Bristol-Myers Squibb
Investigators
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Study Chair: Christos CHOUAID Groupe Français de Pneumo-Cancérologie (GFPC)
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Responsible Party: Groupe Francais De Pneumo-Cancerologie
ClinicalTrials.gov Identifier: NCT05308966    
Other Study ID Numbers: GFPC 04-2021
First Posted: April 4, 2022    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Francais De Pneumo-Cancerologie:
Mesothelioma
Additional relevant MeSH terms:
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Mesothelioma
Mesothelioma, Malignant
Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases