drugset / Trial / NCT03727880

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

NCT03727880

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will test 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 reprograming the tumor microenvironment by targeting FAK following chemotherapy can potentiate anti-programmed death-1 (PD-1) antibody.

Timeline

Start
2019-06-04
Primary completion
2025-01-15
Completion
2025-01-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Defactinib Small molecule 400 mg
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous