Malignant Pleural MesotheliomaMESOIMMUNENCT04775446
Evaluation of the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy
An observational study of Malignant Pleural Mesothelioma, run by Centre Hospitalier Intercommunal Creteil at 5 sites in France.
Trial summary
The objective of this multicentre descriptive analysis is to describe the clinical and biological characteristics of patients who have received Programmed cell death 1 (anti-PD1) / (PDL1) Programmed death-ligand 1 (PDL1) immunotherapy outside of a clinical trial in terms of efficacy and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- Data collection
- How many people
- 116 participants
- Where
- 5 sitesFrance
- Study dates
- 26 Nov 2020to 11 Oct 2021
- 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: Patients with malignant pleural mesothelioma treated with Nivolumab.
Who may be able to join
- Patient over 18 years of age,
- Diagnosis of malignant pleural mesothelioma affirmed by the anatomo-pathological analysis report of a histological sample of the tumour (re-read by MESOPATH).
- Patient who has received at least one injection of anti-PD1 or anti-PDL1 antibodies
Who cannot join
- Explicit refusal by the patient to collect data
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CH Côte basque
Bayonne
CHU Brest
Brest
CH Cherbourg
Cherbourg
CHI Créteil
Créteil
CHU Lille
Lille
About this study
Official title: Multicentre Observational Study Evaluating the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy, in Real Life Setting.
The objective of this multicentre descriptive analysis is to describe the clinical and biological characteristics of patients who have received Programmed cell death 1 (anti-PD1) / (PDL1) Programmed death-ligand 1 (PDL1) immunotherapy outside of a clinical trial in terms of efficacy and safety.
Read the detailed description
Immunotherapy is now an option in the treatment of malignant pleural mesothelioma. A French study, Mesothelioma Avastin plus Pemetrexed-cisplatin Study 2 (MAPS 2), prospective in 2nd line or more, found 40% and 52% disease control rate with respectively an anti-PD1 antibody or a combo of anti-PD1 and Cytotoxic T-Lymphocyte-Associated protein 4 (anti-CTLA4). Safety was rather good with 14% and 26% grade 3-4 in the Nivolumab and combo group respectively.
Thanks to this trial and data from the literature, Programmed cell death 1 (anti-PD1) / (PDL1) Programmed death-ligand 1 (PDL1) immunotherapy became an option in the treatment of malignant pleural mesothelioma, after validation by a multidisciplinary meeting.
The objective of this multicentre descriptive analysis is to describe the clinical and biological characteristics of patients who have received anti-PD1/PDL1 immunotherapy outside of a clinical trial in terms of efficacy and safety.
- Conditions
- Malignant Pleural Mesothelioma
- Being tested
- Data collection
- Keywords
- Immunotherapy, Pleura, Malignant Pleural Mesothelioma
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data entered in a secure computer database
| Study group | Role | What they receive |
|---|---|---|
| Patients with malignant pleural mesothelioma treated with Nivolumab. | Patients with malignant pleural mesothelioma treated with Nivolumab. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control
Disease control rate at 12 weeks
Measured: 12 weeks
Secondary outcomes (10)
Survival with anti-PD1/PDL1 immunotherapy
Overall survival from treatment with anti-PD1/PDL1 immunotherapy
Measured: 12 weeks
Duration of treatment
Duration of treatment with PD1/PDL1 immunotherapy
Measured: 12 weeks
Survival
Overall survival from the start of the first treatment
Measured: 12 weeks
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by previous immunotherapy
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: which immunotherapy, date of treatment beginning/end
Measured: 12 weeks
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by adverse event
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: numbers of treatment related adverse events from CTCAE v4.0
Measured: 12 weeks
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by remarkable event
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: date of best response, date of progression, date of death)
Measured: 12 weeks
To identify factors predictive of treatment response by immunotherapy in responder patients
Identify factors predictive of treatment response by immunotherapy in responder patients by collecting following data: Demographics data, treatment data, and blood test results and histological data
Measured: 12 weeks
To identify factors predictive of the response of immunotherapy treatment of progressive patients
Identify factors predictive of treatment response by immunotherapy of progressive by collecting following data: Demographics data, treatment data, and blood test results and histological data
Measured: 12 weeks
To identify factors predictive of the response of immunotherapy treatment of all patients
Identify factors predictive of treatment response by immunotherapy of all patients by collecting following data: Demographics data, treatment data, and blood test results and histological data
Measured: 12 weeks
To identify factors predictive of the response of immunotherapy treatment according to follow-up treatment
Identify factors predictive of treatment response by immunotherapy according to type of treatment after PD1/PDL1 immunotherapy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start26 Nov 2020
- Primary completion11 Oct 2021
- Study completion11 Oct 2021
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
- Other
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775446
- Sponsor's protocol ID
- MESOIMMUNE
- Acronym
- MESOIMMUNE
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2021
- Last updated
- 4 Feb 2022
- 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 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Observational Study Evaluating the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy, in Real Life Setting.
- ClinicalTrials.gov ID
- NCT04775446
- Acronym / sponsor ID
- MESOIMMUNE / MESOIMMUNE
- Conditions
- Malignant Pleural Mesothelioma
- Keywords
- Immunotherapy, Pleura, Malignant Pleural Mesothelioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 1 Mar 2021 (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.
The objective of this multicentre descriptive analysis is to describe the clinical and biological characteristics of patients who have received Programmed cell death 1 (anti-PD1) / (PDL1) Programmed death-ligand 1 (PDL1) immunotherapy outside of a clinical trial in terms of efficacy and safety.
Detailed description
Immunotherapy is now an option in the treatment of malignant pleural mesothelioma. A French study, Mesothelioma Avastin plus Pemetrexed-cisplatin Study 2 (MAPS 2), prospective in 2nd line or more, found 40% and 52% disease control rate with respectively an anti-PD1 antibody or a combo of anti-PD1 and Cytotoxic T-Lymphocyte-Associated protein 4 (anti-CTLA4). Safety was rather good with 14% and 26% grade 3-4 in the Nivolumab and combo group respectively.
Thanks to this trial and data from the literature, Programmed cell death 1 (anti-PD1) / (PDL1) Programmed death-ligand 1 (PDL1) immunotherapy became an option in the treatment of malignant pleural mesothelioma, after validation by a multidisciplinary meeting.
The objective of this multicentre descriptive analysis is to describe the clinical and biological characteristics of patients who have received anti-PD1/PDL1 immunotherapy outside of a clinical trial in terms of efficacy and safety.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with malignant pleural mesothelioma treated with Nivolumab. | – | Other: Data collectionPatients with malignant pleural mesothelioma treated with Nivolumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant pleural mesothelioma treated with Nivolumab.
Key inclusion criteria (3 listed)
- Patient over 18 years of age,
- Diagnosis of malignant pleural mesothelioma affirmed by the anatomo-pathological analysis report of a histological sample of the tumour (re-read by MESOPATH).
- Patient who has received at least one injection of anti-PD1 or anti-PDL1 antibodies
Key exclusion criteria (1 listed)
- Explicit refusal by the patient to collect data
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 collectionData entered in a secure computer database | Other | Patients with malignant pleural mesothelioma treated with Nivolumab. |
Primary outcome
Disease control
Time frame: 12 weeks
Disease control rate at 12 weeks
10 secondary outcomes
Survival with anti-PD1/PDL1 immunotherapy
Time frame: 12 weeks
Duration of treatment
Time frame: 12 weeks
Survival
Time frame: 12 weeks
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by previous immunotherapy
Time frame: 12 weeks
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by adverse event
Time frame: 12 weeks
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by remarkable event
Time frame: 12 weeks
To identify factors predictive of treatment response by immunotherapy in responder patients
Time frame: 12 weeks
To identify factors predictive of the response of immunotherapy treatment of progressive patients
Time frame: 12 weeks
To identify factors predictive of the response of immunotherapy treatment of all patients
Time frame: 12 weeks
To identify factors predictive of the response of immunotherapy treatment according to follow-up treatment
Time frame: 12 weeks
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 4 Feb 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 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, run by Centre Hospitalier Intercommunal Creteil at 5 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 1 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 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Disease control (time frame: 12 weeks). 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 4 Feb 2022.