pleural mesothelioma
Conditions
Brief summary
Disease control rate (DCR) at 12 weeks, according to RECIST 1.1 criteria modified for mesothelioma, as assessed by an Independent Review Committee (IRC) of 3 expert thoracic radiologists and oncologists
Detailed description
Incidence, nature and severity of AEs, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0), Progression free survival (PFS) as assessed by an IRC of 3 expert thoracic radiologists and oncologists, PFS as assessed by the local investigator, PFS according to previous immunotherapy versus no previous immunotherapy, PFS according to the histological subtype epithelioid vs. non-epithelioid, Overall survival (OS), Best response rate, Duration of response (DOR)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR) at 12 weeks, according to RECIST 1.1 criteria modified for mesothelioma, as assessed by an Independent Review Committee (IRC) of 3 expert thoracic radiologists and oncologists | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence, nature and severity of AEs, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0), Progression free survival (PFS) as assessed by an IRC of 3 expert thoracic radiologists and oncologists, PFS as assessed by the local investigator, PFS according to previous immunotherapy versus no previous immunotherapy, PFS according to the histological subtype epithelioid vs. non-epithelioid, Overall survival (OS), Best response rate, Duration of response (DOR) | — |
Countries
France