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

Last updated: July 31, 2025
Sponsor: Lei Zheng
Overall Status: Active - Not Recruiting

Phase

2

Condition

Pancreatic Cancer

Pancreatic Disorders

Adenocarcinoma

Treatment

Pembrolizumab

Defactinib

Clinical Study ID

NCT03727880
CTMS 25-0012
IRB00182490
STUDY00001506
  • Ages 18-100
  • All Genders

Study 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 Criteria

Inclusion

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 laboratorytests.

  • Must use acceptable form of birth control while on study.

  • Ability to understand and willingness to sign a written informed consent document.

Exclusion

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-inhibitoryT-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 tostudy drug.

  • Is currently or has participated in another investigational study within 4 weeksprior to receiving study drug.

  • History or current use of immunosuppressive medications within 7 days prior to studymedications.

  • Has a known additional malignancy that is progressing or has required activetreatment within the past 2 years or that is expected to require active treatmentwithin two years.

  • Has active autoimmune disease that has required systemic treatment in the past 2years.

  • Has a history of (non-infectious) pneumonitis/interstitial lung disease or currentpneumonitis.

  • 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 anginapectoris, cardiac arrhythmia, or psychiatric illness/social situations that wouldlimit compliance with study requirements.

  • Known allergy or hypersensitivity to the study drugs.

  • Received any growth factors including, but not limited to, granulocyte-colonystimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of study drugadministration.

  • Has history of any organ transplant, including corneal transplants.

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Pembrolizumab
Phase: 2
Study Start date:
June 04, 2019
Estimated Completion Date:
January 15, 2026

Connect with a study center

  • Samuel Oschin Cancer Center at Cedars-Sinai

    Los Angeles, California 90048
    United States

    Site Not Available

  • Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland 21231
    United States

    Site Not Available

  • The University of Texas Health Science Center San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

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