Phase II Randomized Study of Pembrolizumab With or Without Defactinib, a Focal Adhesion Kinase Inhibitor Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma (PDAC)
Summary
The purpose of this phase II study is to evaluate the effectiveness (anti-tumor activity), safety, and ability to increase the body's immune system to fight pancreatic cancer by combining standard chemotherapy before and after surgery, with study drug PD-1 antibody, pembrolizumab, with and without study drug, focal adhesion kinase inhibitor (FAK), defactinib, in people with "high risk" resectable (surgically removable) pancreatic cancer. The purpose of this study is to evaluate if reprogramming the tumor micro environment by targeting FAK following chemotherapy can potentiate anti-programmed death-1 (PD-1) antibody.
General Information
NCT#: NCT03727880
Study ID: J18140
Trial Phase: Phase II
Trial Sponsor: Merck Sharp & Dohme Corp., Sidney Kimmel Comprehensive Cancer Center, Verastem, Inc.
Therapies Used in This Trial: Pembrolizumab, Defactinib