Maintenance Combinatorial Myeloid Immunotherapy for Unresectable Pancreatic Cancer
Trial Parameters
Brief Summary
Phase II, open-label, single-arm study of CD40/Dectin-1 immunotherapy as maintenance treatment in patients with unresectable pancreatic ductal adenocarcinoma (PDA) who have not progressed following 4-6 months of first line (1L) chemotherapy.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years old * Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent * Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma that is either locally advanced and unresectable, or metastatic * Have received a minimum of 16 and no more than 24 weeks of a first line chemotherapy-based standard of care regimen, resulting in either a PR or SD with no evidence of progression within 14 days prior to first dose of study treatment. o Note: Patients must demonstrate at least stable disease (SD) or partial response (PR) by imaging. A single assessment showing PR at the end of chemotherapy (up to 24 weeks) is sufficient; confirmation is not required. If chemotherapy was discontinued between 16-24 weeks due to legitimate medical reasons (as determined by the investigator), the patient may still be eligible if they demonstrated SD or PR prior to discontinuation. * Have