Evaluation of the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy
MESOIMMUNE
Multicentre Observational Study Evaluating the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy, in Real Life Setting.
1 other identifier
observational
116
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2020
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 26, 2020
CompletedFirst Submitted
Initial submission to the registry
February 1, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2021
CompletedFebruary 4, 2022
February 1, 2022
11 months
February 1, 2021
February 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease control
Disease control rate at 12 weeks
12 weeks
Secondary Outcomes (10)
Survival with anti-PD1/PDL1 immunotherapy
12 weeks
Duration of treatment
12 weeks
Survival
12 weeks
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by previous immunotherapy
12 weeks
Tolerance of treatment with PD1/PDL1 immunotherapy evaluated by adverse event
12 weeks
- +5 more secondary outcomes
Study Arms (1)
Patients with malignant pleural mesothelioma treated with Nivolumab.
Patients with malignant pleural mesothelioma treated with Nivolumab.
Interventions
Data entered in a secure computer database
Eligibility Criteria
Patients with malignant pleural mesothelioma treated with Nivolumab.
You may qualify if:
- 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
You may not qualify if:
- Explicit refusal by the patient to collect data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
CH Côte basque
Bayonne, France
CHU Brest
Brest, France
CH Cherbourg
Cherbourg, France
CHI Créteil
Créteil, France
CHU Lille
Lille, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2021
First Posted
March 1, 2021
Study Start
November 26, 2020
Primary Completion
October 11, 2021
Study Completion
October 11, 2021
Last Updated
February 4, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share