Clinical trialPhase 2Completed
Study of Pembrolizumab With or Without Defactinib Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma
A Randomized Phase II 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)
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 4 June 2019
- Expected end
- 15 January 2025
- Enrollment
- 28 participants
- Sites
- 3
- Primary outcomes
- Pathologic Complete Response (pCR) Rate
- Sponsor
- Other
- Results posted
- 2026-02-04
- Last update
- 4 February 2026
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Pathologic Complete Response (pCR) Rate [4 years]. Number, Percentage of participants. Arm A - Pembrolizumab and Defactinib (n=10): 0; Arm B - Pembrolizumab (n=8): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [4 years]. Mean, months (Standard Deviation). Arm A - Pembrolizumab and Defactinib (n=13): 25.01 (14.48); Arm B - Pembrolizumab (n=10): 27.39 (19.54).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Disease Free Survival (DFS) [4 years]. Mean, months (Standard Deviation). Arm A - Pembrolizumab and Defactinib (n=11): 16.59 (14.33); Arm B - Pembrolizumab (n=8): 15.99 (15.20).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants Experiencing Study Drug-related Toxicities [4 years]. Number, participants. Arm A - Pembrolizumab and Defactinib (n=14): 6; Arm B - Pembrolizumab (n=14): 3.