Study on Pembrolizumab With or Without Defactinib Before and After Surgery for Treating Resectable Pancreatic Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials ID:NCT03727880
This clinical trial is exploring whether combining standard chemotherapy with pembrolizumab, and possibly defactinib, can improve the body's immune response to fight pancreatic cancer that can be surgically removed. The study aims to see if this combination is safe and effective in treating high-risk pancreatic cancer.
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Program Overview
The study is testing a new treatment approach for pancreatic cancer that can be surgically removed. It involves using standard chemotherapy along with pembrolizumab, a drug that helps the immune system fight cancer, and possibly defactinib, which targets a specific part of the cancer environment. The goal is to see if this combination can make the immune system more effective against the cancer.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Diagnosed with pancreatic ductal adenocarcinoma.
- Cancer must be removable by surgery at diagnosis.
- No previous systemic therapy for this type of cancer.
- Cancer stage must be IIb or lower at diagnosis and enrollment.
- High levels of a tumor marker called CA 19-9.
- Good overall health with an ECOG performance status of 0 or 1.
- Must have adequate organ function based on specific lab tests.
- Must agree to use effective birth control during the study.
- Must understand and agree to sign a consent form.
Exclusion Criteria
- Have had any prior chemotherapy, radiotherapy, or experimental treatments for pancreatic cancer.
- Have previously received treatments targeting PD-1, PD-L1, PD-L2, CTLA-4, or similar immune system targets.
- Have used a FAK inhibitor before.
- Women who are pregnant or breastfeeding.
- Have received a live vaccine within 30 days before starting the study.
- Are currently in or have recently been in another clinical trial within 4 weeks before starting the study.
- Have used immunosuppressive medications within 7 days before starting the study.
- Have another progressing cancer or one that needs treatment within the past 2 years.
- Have an active autoimmune disease needing treatment in the past 2 years.
- Have a history of lung inflammation or current lung issues.
- Have an active infection needing treatment.
- Have HIV or hepatitis B or C infections.
- Have uncontrolled health issues like heart failure, unstable chest pain, irregular heartbeat, or mental health issues affecting study participation.
- Have allergies to the study drugs.
- Have used growth factors like G-CSF or GM-CSF within 14 days before starting the study.
- Have had any organ transplant, including corneal transplants.
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