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Evaluation of the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy (MESOIMMUNE)

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ClinicalTrials.gov Identifier: NCT04775446
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Brief 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.

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

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Other
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.
Actual Study Start Date : November 26, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Group/Cohort Intervention/treatment
Patients with malignant pleural mesothelioma treated with Nivolumab.
Patients with malignant pleural mesothelioma treated with Nivolumab.
Other: Data collection
Data entered in a secure computer database




Primary Outcome Measures :
  1. Disease control [ Time Frame: 12 weeks ]
    Disease control rate at 12 weeks


Secondary Outcome Measures :
  1. Survival with anti-PD1/PDL1 immunotherapy [ Time Frame: 12 weeks ]
    Overall survival from treatment with anti-PD1/PDL1 immunotherapy

  2. Duration of treatment [ Time Frame: 12 weeks ]
    Duration of treatment with PD1/PDL1 immunotherapy

  3. Survival [ Time Frame: 12 weeks ]
    Overall survival from the start of the first treatment

  4. Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by previous immunotherapy [ Time Frame: 12 weeks ]
    Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: which immunotherapy, date of treatment beginning/end

  5. Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by adverse event [ Time Frame: 12 weeks ]
    Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: numbers of treatment related adverse events from CTCAE v4.0

  6. Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by remarkable event [ Time Frame: 12 weeks ]
    Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by following data: date of best response, date of progression, date of death)

  7. To identify factors predictive of treatment response by immunotherapy in responder patients [ Time Frame: 12 weeks ]
    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

  8. To identify factors predictive of the response of immunotherapy treatment of progressive patients [ Time Frame: 12 weeks ]
    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

  9. To identify factors predictive of the response of immunotherapy treatment of all patients [ Time Frame: 12 weeks ]
    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

  10. To identify factors predictive of the response of immunotherapy treatment according to follow-up treatment [ Time Frame: 12 weeks ]
    Identify factors predictive of treatment response by immunotherapy according to type of treatment after PD1/PDL1 immunotherapy



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:   Non-Probability Sample
Study Population
Patients with malignant pleural mesothelioma treated with Nivolumab.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Explicit refusal by the patient to collect data

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): NCT04775446


Contacts
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Contact: Camille JUNG 0157022268 ext +33 camille.jung@chicreteil.fr

Locations
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France
CH Côte basque Recruiting
Bayonne, France
Contact: Marielle Sabatini         
CHU Brest Recruiting
Brest, France
Contact: Gilles Robinet         
CH Cherbourg Recruiting
Cherbourg, France
Contact: Eric Kaluzinski         
CHI Créteil Recruiting
Créteil, France
Contact: Jean-Baptiste Assié         
CHU Lille Recruiting
Lille, France
Contact: Arnaud Scherpereel         
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT04775446    
Other Study ID Numbers: MESOIMMUNE
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
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 Centre Hospitalier Intercommunal Creteil:
Immunotherapy
Pleura
Malignant Pleural Mesothelioma
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial