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

COMPLETEDPHASE2

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)

NCT03727880•Lei Zheng

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

Locations (3)

Samuel Oschin Cancer Center at Cedars-Sinai

Los Angeles, California, United States

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

The University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

Key Dates

Start Date

June 4, 2019

Primary Completion Date

January 15, 2025

Completion Date

January 15, 2025

Last Updated

February 4, 2026

Enrollment

ACTUAL participants

Conditions

Resectable Pancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Ductal Adenocarcinoma

Interventions

Pembrolizumab

DRUG

Defactinib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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