Study of Pembrolizumab With or Without Defactinib Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma

This is an interventional treatment trial for Resectable Pancreatic Ductal Adenocarcinoma (PDAC) focused on measuring Pembrolizumab, Defactinib, Immunotherapy, Anti-PD-1, Antibody, PD-L1, Pancreatic cancer, Neoadjuvant chemotherapy, Adjuvant chemotherapy, PDAC - Pancreatic Ductal Adenocarcinoma, FAK (focal adhesion kinase) inhibitor, Resectable Pancreatic Adenocarcinoma, High Risk Resectable Pancreatic Cancer, Tumor microenvironment, CA 19-9, Surgery, Pancreatectomy Read More

Inclusion Criteria:

• Age ≥18 years.
• Has pancreatic ductal adenocarcinoma
• Has resectable disease at the time of diagnosis
• Has not received any systemic therapy for pancreatic ductal adenocarcinoma
• Has stage ≤ IIb disease at time of diagnosis and enrollment
• Elevated tumor marker, CA (carbohydrate antigen) 19-9 >200
• ECOG performance status 0 or 1
• Patient must have adequate organ function defined by the study-specified laboratory tests.
• Must use acceptable form of birth control while on study.
• Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

Patients who have received any prior chemotherapy, radiotherapy or investigational agents for pancreatic cancer.

• Patients who have received prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
• Has received prior therapy with FAK inhibitor.
• Woman who are pregnant or breastfeeding.
• Have received a live vaccine or live-attenuated vaccine within 30 days prior to study drug.
• Is currently or has participated in another investigational study within 4 weeks prior to receiving study drug.
• History or current use of immunosuppressive medications within 7 days prior to study medications.
• Has a known additional malignancy that is progressing or has required active treatment within the past 2 years or that is expected to require active treatment within two years.
• Has active autoimmune disease that has required systemic treatment in the past 2 years.
• Has a history of (non-infectious) pneumonitis/interstitial lung disease or current pneumonitis.
• Has an active infection requiring systemic therapy.
• Infection with HIV or hepatitis B or C.
• Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Known allergy or hypersensitivity to the study drugs.
• Received any growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of study drug administration.
• Has history of any organ transplant, including corneal transplants.