Study of Pembrolizumab With or Without Defactinib Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma
- Conditions
- Resectable Pancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Ductal Adenocarcinoma
- Interventions
- Registration Number
- NCT03727880
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A - Pembrolizumab and Defactinib Pembrolizumab - Arm B - Pembrolizumab Pembrolizumab - Arm A - Pembrolizumab and Defactinib Defactinib -
- Primary Outcome Measures
Name Time Method Pathologic complete response (pCR) rate 4 years Percent of subjects with a pathologic complete response (pCR) per the tumor regression grade scores established by the College of American Pathologist: Grade 0= complete response (no viable cancer cells), Grade 1= near complete response (single cells or rare small groups of cancer cells), Grade 2= partial response (residual tumor with evidence of regression), or Grade 3= no response (extensive residual tumor with no evidence of regression).
- Secondary Outcome Measures
Name Time Method Number of participants experiencing study drug-related toxicities 4 years Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0
Overall survival (OS) 4 years Number of months until death
Disease free survival (DFS) 4 years Number of months until disease recurrence
Trial Locations
- Locations (3)
The University of Texas Health Science Center San Antonio
🇺🇸San Antonio, Texas, United States
Samuel Oschin Cancer Center at Cedars-Sinai
🇺🇸Los Angeles, California, United States
Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States