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

  • STATUS
    Recruiting
  • End date
    May 6, 2023
  • participants needed
    36
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 6 April 2022
cancer
resectable pancreatic ductal adenocarcinoma

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.

Details
Condition Resectable Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Ductal Adenocarcinoma
Treatment Pembrolizumab, Defactinib
Clinical Study IdentifierNCT03727880
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on6 April 2022

Eligibility

Yes No Not Sure

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
Has received prior therapy with FAK inhibitor
receptor (e.g., CTLA-4, OX 40, CD137)
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
Has an active infection requiring systemic therapy
medications
Infection with HIV or hepatitis B or C
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
Known allergy or hypersensitivity to the study drugs
years
Has history of any organ transplant, including corneal transplants
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
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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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