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Completed

NCT Number: NCT04775446

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

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.

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Key information

Conditions

Malignant Pleural Mesothelioma Adenoma Lung Diseases Lung Neoplasms Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Côte basque, Bayonne, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

Data entered in a secure computer database

Primary outcomes

  1. Disease control

    Time frame: 12 weeks

    Disease control rate at 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study 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.

Acronym: MESOIMMUNE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2021
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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