Peritoneal Mesothelioma
Conditions
Brief summary
The progression free survival in patients that have received neo-adjuvant and adjuvant treatment with anti-PD-1 and vaccinations of DCT (5 administrations in total or less in case of production shortage) and cytoreduction.
Detailed description
Lymphocyte infiltration and activity will be measured by TCR repetoire analysis and immune phenotyping. Lymphocyte activity will be measured by apoptosis and proliferation markers using flow cytometry., Safety will be measured in AE’s and SAE’s, Radiological response will be measured using CT scans following RECIST 1.1 criteria, resulting in: progressive or stable disease and partial or complete response., PCI will be evaluated during DLS and can be compared to the PCI seen at CRS-HIPEC, Overall survival will be a secondary objective to evaluate.
Interventions
DRUGNIVOLUMAB
Sponsors
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The progression free survival in patients that have received neo-adjuvant and adjuvant treatment with anti-PD-1 and vaccinations of DCT (5 administrations in total or less in case of production shortage) and cytoreduction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Lymphocyte infiltration and activity will be measured by TCR repetoire analysis and immune phenotyping. Lymphocyte activity will be measured by apoptosis and proliferation markers using flow cytometry., Safety will be measured in AE’s and SAE’s, Radiological response will be measured using CT scans following RECIST 1.1 criteria, resulting in: progressive or stable disease and partial or complete response., PCI will be evaluated during DLS and can be compared to the PCI seen at CRS-HIPEC, Overall survival will be a secondary objective to evaluate. | — |
Countries
Netherlands
Outcome results
None listed