Advanced Pancreatic Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Must have histological or cytological confirmed diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, which has progressed on or after one line of chemotherapy ECOG Performance status 0-1 Adequate organ functions Measurable disease
Exclusion criteria
Exclusion criteria: Suspected or known CNS metastasis Participants with active, known, or suspected autoimmune disease Uncontrolled or significant cardiovascular disease Prior exposure to selected immune cell-modulating antibody regimens
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Median progression free survival (mPFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Incidence of AE, SAE, death, laboratory abnormalities and AE leading to discontinuation PK parameters Objective response rate (ORR) Median duration of response (MDOR) Overall survival rate (OSR) | — |
Countries
Asia except Japan, Japan, North America