Pancreatic cancer
Conditions
Brief summary
The safety and tolerability of the treatment will be evaluated by the assessment of all adverse events (AEs) occurring during treatment—both those considered treatment-related and unrelated. Adverse events will be collected from Cycle 1 Day 1 through the final study visit and will be graded for severity according to the NCI-CTCAE, version 5.0. Safety will also be evaluated by clinical laboratory tests, physica
Detailed description
Secondary Efficacy Variables: Progression-free survival and overall survival, Secondary Outcome Biomarker Variables: • NK cell subsets in blood, including immature (CD16-) and cytotoxic (CD16+) subsets, activation markers, natural cytotoxicity receptors including NKp30, NKp46 and NKG2D, killer-immunoglobulin receptors. • T cell subsets including CD4+/25 regulatory T cells and naive, central memory, effector memory and effector CD8+ T cells, continuation Secondary Outcome: Biomarker Variables: • Myeloid cell populations including granulocytes and monocytes, MDSC, dendritic cells, activation markers, PD-L1, PD-L2 and related immune biomarkers. • Serum CA 19-9 • Serum levels of cytokines, chemokines and other soluble mediators of inflammation • Amount of tumor-infiltrating lymphocytes (TILs) and tumor-infiltrating myeloid cells
Interventions
DRUGCeplene 0.5 mg/0.5 mL solution for injection
Sponsors
Vaestra Goetalandsregionen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of the treatment will be evaluated by the assessment of all adverse events (AEs) occurring during treatment—both those considered treatment-related and unrelated. Adverse events will be collected from Cycle 1 Day 1 through the final study visit and will be graded for severity according to the NCI-CTCAE, version 5.0. Safety will also be evaluated by clinical laboratory tests, physica | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Variables: Progression-free survival and overall survival, Secondary Outcome Biomarker Variables: • NK cell subsets in blood, including immature (CD16-) and cytotoxic (CD16+) subsets, activation markers, natural cytotoxicity receptors including NKp30, NKp46 and NKG2D, killer-immunoglobulin receptors. • T cell subsets including CD4+/25 regulatory T cells and naive, central memory, effector memory and effector CD8+ T cells, continuation Secondary Outcome: Biomarker Variables: • Myeloid cell populations including granulocytes and monocytes, MDSC, dendritic cells, activation markers, PD-L1, PD-L2 and related immune biomarkers. • Serum CA 19-9 • Serum levels of cytokines, chemokines and other soluble mediators of inflammation • Amount of tumor-infiltrating lymphocytes (TILs) and tumor-infiltrating myeloid cells | — |
Countries
Sweden
Outcome results
None listed