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

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03727880

Patient View

This study evaluates the anti-tumor activity and safety of pembrolizumab, with or without defactinib, in high-risk resectable pancreatic cancer. Eligible participants are adults with stage ≤ IIb pancreatic ductal adenocarcinoma, no prior systemic therapy, and adequate organ function. Interventions include pembrolizumab and defactinib following standard chemotherapy, both pre- and post-surgery.

Patient Parameters

Program Overview

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 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.
  • 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 angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Known allergy or hypersensitivity to the study drugs.
  • Received any growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of study drug administration.
  • Has history of any organ transplant, including corneal transplants.

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