Malignant Pleural MesotheliomaMESO-IMMUNENCT05308966
Observational Study in Patients With Previously Unresectable Malignant Pleural Mesothelioma Treated With Nivolumab and Ipilimumab (MESO-IMMUNE)
An observational study of Malignant Pleural Mesothelioma and Unresectable Malignant Neoplasm, run by Groupe Francais De Pneumo-Cancerologie at 63 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma, Unresectable Malignant Neoplasm
- What is being tested?
- Data collection
- How many people
- 204 participants
- Where
- 63 sitesFrance
- Study dates
- 3 May 2022to 27 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
France63 sites
CHU du Pays d'Aix
Aix-en-Provence, 13616
CH Albi
Albi, 81013
CHU Angers
Angers, 49033
CH Argenteuil
Argenteuil, 95010
CH Avignon
Avignon, 84000
CH Bastia
Bastia, 20200
CH Bayonne
Bayonne, 64100
CHU Besançon
Besançon, 25000
Clinique Ambroise Paré
Beuvry, 63660
CH Bligny
Bligny, 91640
Clinique Bordeaux
Bordeaux, 33000
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
CHU Morvan
Brest, 29200
Clinique Pasteur
Brest, 29200
Hôpital Louis Pradel
Bron, 69500
CHU Caen
Caen, 14033
CH Cannes
Cannes, 06400
CH du Cotentin
Cherbourg, 50102
CHU Hôpital Montpied
Clermont-Ferrand, 63000
Unicancer
Clermont-Ferrand, 63000
Hôpital Louis Pasteur
Colmar, 68000
CH Dijon Bourgogne
Dijon, 21000
CH Eure-Seine
Évreux, 27015
Clinique Gentilly
Gentilly, 94250
CHD les Oudaries
La Roche-sur-Yon, 85000
GH Le Havre
Le Havre, 76083
CH du Mans
Le Mans, 72000
CH Libourne
Libourne, 33500
CHU Lille
Lille, 59000
CH de Longjumeau
Longjumeau, 91160
Hôpital du Scorff
Lorient, 56100
Centre Léon Bérard
Lyon, 69373
IPC
Marseille, 13009
Hôpital Nord
Marseille, 13915
CAC Mougins
Mougins, 06250
CH Nevers
Nevers, 58000
Clinique Saint Georges
Nice, 06000
Centre Antoine Lacassagne
Nice, 06149
Institut Curie
Paris, 75005
Hôpital Cochin
Paris, 75014
Hôpital Bichat
Paris, 75018
Hôpital La Pitié-Salpêtrière
Paris, 75651
GH Paris Site St Joseph
Paris, 75674
Hôpital Haut-Lévèque - Groupe Hospitalier SUD
Pessac, 33604
CHU La Mileterie
Poitiers, 86021
CH Annecy Genevois
Pringy, 74374
CH Cornouaille
Quimper, 02900
CHU Ponchailloux
Rennes, 35000
Clinique Saint Grégoire
Rennes, 35000
Hôpital Charles Nicolle
Rouen, 76031
Hôpital privé de la Loire
Saint-Etienne, 42100
Insititut de Cancerologie de l'Ouest
Saint-Herblain, 44805
HIA Begin
Saint-Mandé, 94160
Clinique de l'Estuaire
Saint-Nazaire, 44600
CH St Quentin
Saint-Quentin, 02321
CH de Saint Malo
St-Malo, 35400
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 76091
CHITS Toulon Sainte Musse
Toulon, 83056
HIA St Anne
Toulon, 83800
Hôpital Larrey
Toulouse, 31059
CHRU Bretonneau
Tours, 37044
CH Villefranche
Villefranche-sur-Saône, 69400
CH Villeurbanne
Villeurbanne, 69100
About this study
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
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.
Read more
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.
- Being tested
- Data collection
- Keywords
- Mesothelioma
- Medical subject headings
- Mesothelioma, Malignant, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Baseline
Overall Survival (OS)
OS defined as the time from first treatment start to death for any cause expressed in months
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start3 May 2022
- Primary completion27 Aug 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Francais De Pneumo-Cancerologie
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Christos CHOUAID, Study chair, Groupe Français de Pneumo-Cancérologie (GFPC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308966
- Sponsor's protocol ID
- GFPC 04-2021
- Acronym
- MESO-IMMUNE
- Status last verified
- Aug 2025
- First submitted
- 17 Jan 2022
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05308966
- Acronym / sponsor ID
- MESO-IMMUNE / GFPC 04-2021
- Keywords
- Mesothelioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Groupe Francais De Pneumo-CancerologieUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 3 May 2022 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient presenting MPS treated with nivolumab and ipilimumab | – | Other: Data collectionAdult 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionObservational 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). | Other | Patient presenting MPS treated with nivolumab and ipilimumab |
Primary outcome
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
16 secondary outcomes
Potential professional exposure(s)
Time frame: At Baseline
Eastern Cooperative Oncology Group performance status (PS)
Time frame: At Baseline
Body weight
Time frame: At Baseline
Body mass index (BMI)
Time frame: At Baseline
Smoking status
Time frame: At Baseline
Medical history
Time frame: At Baseline
Comorbidities
Time frame: At Baseline
Past history of cancer or auto-immune disease
Time frame: At Baseline
Overall Survival (OS)
Time frame: From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months)
Objective Response Rate (ORR)
Time frame: From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months)
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)
Treatment duration
Time frame: From first dose of combination Nivolumab-Ipilimumab to the end of treatment, up to 48 months (study duration)
Reasons for treatment discontinuation
Time frame: From first dose of combination Nivolumab-Ipilimumab to the end of treatment, up to 48 months (study duration)
Post-progression treatments
Time frame: 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
Time frame: 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
Time frame: From first dose of combination Nivolumab-Ipilimumab to the end of the study (up to 48 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christos CHOUAID study chair
Groupe Français de Pneumo-Cancérologie (GFPC)
63 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Pleural Mesothelioma and Unresectable Malignant Neoplasm, run by Groupe Francais De Pneumo-Cancerologie at 63 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.