Johns Hopkins University; EIIT2020-Osipov; Ph 2; OL; PDAC; Pembrolizumab with or without Defactinib

What is the Purpose of this Study?

This study focuses on patients who have been recently diagnosed with high-risk pancreatic cancer and whose cancer was determined to be surgically removable (resectable). The purpose of the study is to evaluate the effectiveness (anti-tumor activity) and safety of the combination of standard chemotherapy with pembrolizumab (study drug), with and without defactinib (another study drug). Researchers also want to learn whether the combination of these drugs increases the ability of the body's immune system to fight pancreatic cancer.

Pembrolizumab is an antibody (protein that the immune system uses to fight infection) and may be able to boost the immune system against cancer. It is approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but is not approved to treat pancreatic cancer. Defactinib works by binding to another molecule that controls various aspects of the environment around a tumor, influences the immune system’s ability to fight cancer, and kills cancer stem cells.

Standard-of-care chemotherapy is cytotoxic chemotherapy (commonly utilized in the treatment of pancreatic cancer). The combination of standard chemotherapy, pembrolizumab and defactinib is investigational.

Eligibility

* 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

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.

Show less

Where can I participate?

CS Cancer at Cedars-Sinai Medical Center

More about this Clinical Trial

What is the full name of this clinical trial?

EIIT2020-Osipov-PemDef/J18140: 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

Study Details

Disease Type/Condition

Pancreas

Principal Investigator

Osipov, Arsen

Co-Investigators

Andrew Hendifar, Jun Gong, Kamya Sankar, Matthew Ebia

Age Group

Adult

Phase

IRB Number

STUDY00001038

ClinicalTrials.gov ID

NCT03727880

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org