Colorectal cancer
Conditions
Brief summary
To evaluate the safety and tolerability of Ca-EP and IRE in combination with pembrolizumab
Detailed description
To evaluate the systemic response, measured by biopsy data from a metastasis not treated with IRE, To evaluate the efficacy of Ca-EP and IRE in combination with pembrolizumab, To evaluate tumor response per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, To evaluate tumor response by dynamic contrast enhanced ultra sound (DCE-US), To evaluate the phenotypic change of the TILs from the primary tumor by flow cytometry, To evaluate progression free survival, To evaluate overall survival, To evaluate quality of life (by questionnaire EORTC QLQ-C30)
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGCALCIUM CHLORIDE HEXAHYDRATE
Sponsors
Zealand University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of Ca-EP and IRE in combination with pembrolizumab | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the systemic response, measured by biopsy data from a metastasis not treated with IRE, To evaluate the efficacy of Ca-EP and IRE in combination with pembrolizumab, To evaluate tumor response per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, To evaluate tumor response by dynamic contrast enhanced ultra sound (DCE-US), To evaluate the phenotypic change of the TILs from the primary tumor by flow cytometry, To evaluate progression free survival, To evaluate overall survival, To evaluate quality of life (by questionnaire EORTC QLQ-C30) | — |
Countries
Denmark
Outcome results
None listed