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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with malignant pleural mesothelioma treated with Nivolumab. | Patients with malignant pleural mesothelioma treated with Nivolumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Data entered in a secure computer database |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease control | Disease control rate at 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Survival with anti-PD1/PDL1 immunotherapy | Overall survival from treatment with anti-PD1/PDL1 immunotherapy | 12 weeks |
| Duration of treatment | Duration of treatment with PD1/PDL1 immunotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with malignant pleural mesothelioma treated with Nivolumab.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Côte basque | Bayonne | France | ||||
| CHU Brest |
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| 12 weeks |
| Survival | Overall survival from the start of the first treatment | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 12 weeks |
| Brest |
| France |
| CH Cherbourg | Cherbourg | France |
| CHI Créteil | Créteil | France |
| CHU Lille | Lille | France |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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