malignant pleural mesothelioma
Conditions
Brief summary
The proportion of patients with an objective response, defined by Modified RECIST 1.1 criteria for malignant pleural mesothelioma (see appendix C), determined by the local physician and compare ORR with historical controls.
Detailed description
Extent of exposure, AEs, SAEs, treatment related AEs (TRAEs/SAEs) , AE’s leading to discontinuation of study drug(s)/withdrawal, fatal TRAEs and deaths. Other AEs that the investigator deemed important to report and reasons for discontinuation of study drug(s). AE grading will be performed by NCI Common Terminology Criteria for Adverse Events Version 5.0., To estimate the disease control rate (DCR) progression-free survival (PFS) determined by defined by ModifiedRECIST 1.1 criteria for malignant pleural mesothelioma Duration of response (DOR) (all determined by the local physician) and overall survival (OS)., To describe the DCR, ORR, DOR and PFS by independent radiological review
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with an objective response, defined by Modified RECIST 1.1 criteria for malignant pleural mesothelioma (see appendix C), determined by the local physician and compare ORR with historical controls. | — |
Secondary
| Measure | Time frame |
|---|---|
| Extent of exposure, AEs, SAEs, treatment related AEs (TRAEs/SAEs) , AE’s leading to discontinuation of study drug(s)/withdrawal, fatal TRAEs and deaths. Other AEs that the investigator deemed important to report and reasons for discontinuation of study drug(s). AE grading will be performed by NCI Common Terminology Criteria for Adverse Events Version 5.0., To estimate the disease control rate (DCR) progression-free survival (PFS) determined by defined by ModifiedRECIST 1.1 criteria for malignant pleural mesothelioma Duration of response (DOR) (all determined by the local physician) and overall survival (OS)., To describe the DCR, ORR, DOR and PFS by independent radiological review | — |
Countries
Netherlands
Outcome results
None listed