MALIGNANT PLEURAL MESOTHELIOMA PATIENTS
Conditions
Brief summary
DFS, defined as the time from initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first. DFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Detailed description
-Incidence, nature, frequency, duration, timing and severity of serious adverse events (SAEs) and non-serious adverse events (AEs) related to atezolizumab treatment graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5. -OS, defined as the time from start of study drug to the date of death from any cause. -EQ-5D-3L questionnaire
Interventions
DRUGATEZOLIZUMAB
DRUGMPDL3280A Placebo
Sponsors
G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS, defined as the time from initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first. DFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). | — |
Secondary
| Measure | Time frame |
|---|---|
| -Incidence, nature, frequency, duration, timing and severity of serious adverse events (SAEs) and non-serious adverse events (AEs) related to atezolizumab treatment graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5. -OS, defined as the time from start of study drug to the date of death from any cause. -EQ-5D-3L questionnaire | — |
Countries
Italy
Outcome results
None listed