Malignant pleural mesothelioma, epithelioid subtype (stage I-IV)
Conditions
Brief summary
Feasibility: the proportion of patients who completed study treatment schedule (i.e. administration of four platinum/pemetrexed-based chemotherapy cycles in combination with four atezolizumab treatments and four WT1/DC vaccinations, Safety, based on the occurrence of reported AEs and SAEs during investigational treatment administration and during follow-up: (A) Proportions of patients that experienced (S)AEs possibly, probably or definitely related to pemetrexed and/or cisplatin/carboplatin and/or atezolizumab and/or WT1/DC vaccination (B) Number and grade of AEs and SAEs
Detailed description
Clinical efficacy, including: (A) Best overall response (BOR), duration of response (DOR), disease control rate (DCR), objective response rate (ORR) and progression free survival (PFS), (B) Overall survival (OS), Immunogenicity: Functional WT1-specific T cell responses
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility: the proportion of patients who completed study treatment schedule (i.e. administration of four platinum/pemetrexed-based chemotherapy cycles in combination with four atezolizumab treatments and four WT1/DC vaccinations, Safety, based on the occurrence of reported AEs and SAEs during investigational treatment administration and during follow-up: (A) Proportions of patients that experienced (S)AEs possibly, probably or definitely related to pemetrexed and/or cisplatin/carboplatin and/or atezolizumab and/or WT1/DC vaccination (B) Number and grade of AEs and SAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy, including: (A) Best overall response (BOR), duration of response (DOR), disease control rate (DCR), objective response rate (ORR) and progression free survival (PFS), (B) Overall survival (OS), Immunogenicity: Functional WT1-specific T cell responses | — |
Countries
Belgium