Pleural mesothelioma
Conditions
Brief summary
Disease Control Rate (DCR) at 6 months, according to RECIST1.1 criteria modified for mesothelioma, as assessed by an Independent Review Committee (IRC)
Detailed description
Incidence, nature, and severity of adverse events (AE), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), Rate of Hyper-Progressive Disease (HPD), Progression Free Survival (PFS) as assessed by an IRC, PFS as assessed by the investigator, PFS according to the histological subtype epithelioid vs. non-epithelioid, Overall Survival (OS), Best Overall Response Rate (ORR), Clinically significant changes in symptoms and function, using EQ-5D-5L and LCSS-meso scores
Interventions
DRUGFianlimab
DRUGLIBTAYO 350 mg concentrate for solution for infusion.
Sponsors
Intergroupe Francophone De Cancerologie Thoracique
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR) at 6 months, according to RECIST1.1 criteria modified for mesothelioma, as assessed by an Independent Review Committee (IRC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence, nature, and severity of adverse events (AE), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), Rate of Hyper-Progressive Disease (HPD), Progression Free Survival (PFS) as assessed by an IRC, PFS as assessed by the investigator, PFS according to the histological subtype epithelioid vs. non-epithelioid, Overall Survival (OS), Best Overall Response Rate (ORR), Clinically significant changes in symptoms and function, using EQ-5D-5L and LCSS-meso scores | — |
Countries
France
Outcome results
None listed