Phase
Condition
Pancreatic Cancer
Pancreatic Disorders
Cancer
Treatment
EGFR FPBMC
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed locally advanced pancreatic cancer (LAPC)/unresectablepancreatic cancer (UPC) or metastatic pancreatic cancer (MPC) not eligible forcurative intent therapy
Received at least 1 line of chemotherapy and have stable disease (SD) or better for 3 months prior to enrollment. Therapy should consist of either a gemcitabine, 5FU-based (including capecitabine) or albumin-bound paclitaxel-based regimen.Patients with actionable mutations should have received targeted therapy prior toenrollment on trial. Patients who qualify for immunotherapy due to mismatch repairprotein/microsatellite stable and tumor mutational burden status should also havereceived immunotherapy prior to enrollment on trial.
Measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Age ≥ 18 years
Females of childbearing potential must have a negative pregnancy test within 7 daysprior to enrollment/registration
Females of childbearing potential and males must agree to use an effective methodfor contraception for the duration of the treatment with study drug plus 90 days (duration of sperm turnover). Males must also abstain from sperm donations duringstudy treatment and for at least 90 days after the last dose of study drug.
Adequate organ function within 14 days prior to registration, defined as thefollowing:
Absolute neutrophil count >= 500/mm3
Absolute lymphocyte count >= 400/mm3
Platelets >= 75,000/mm3
Hemoglobin >= 8 g/dL
Serum creatinine < 2.0mg/dL or calculated/measured creatinine clearance >= 50ml/min
Bilirubin <= 2 mg/dL
Aspartate transferase (AST) and Alanine transaminase (ALT) <= 5.0 x upper limitof normal (ULN)
Alpha gal < 0.35 IU/ml or "negative"
Ability to provide informed consent and provision of written informed consent
Stated willingness to comply with all study procedures and availability for theduration of the study
Adequate cardiac function as defined as:
No uncontrolled angina or severe ventricular arrhythmias
No clinically significant pericardial disease
No history of myocardial infarction (MI) in the last year before registration
No Class 3 or higher New York Heart Association Congestive Heart Failure
Exclusion
Exclusion Criteria:
Known hypersensitivity to cetuximab
Treatment with investigational agent within 3 weeks prior to registration
Serious non-healing wound, ulcer, bone fracture, major surgical procedure, openbiopsy, or significant traumatic injury within 28 days prior to registration
Known active liver disease, human immunodeficiency virus (HIV)+ or evidence ofactive Hepatitis C or B virus; bleeding or condition associated with high-riskbleeding (anticoagulation is allowed)
Active infection; prior antibiotic/antifungal/antiviral therapies within 2 weeksprior to registration
History of a myocardial infarction within 1 year prior to registration
Patients with a prior or concurrent malignancy whose natural history or treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen are eligible for this trial
Autoimmune disease that has required systemic treatment with chronic steroids orimmunosuppressive therapy in the 2 years prior to registration (thyroxine, insulin,or corticosteroid replacement is allowed)
History or evidence of any condition that might confound the results of the trial,interfere with the subject's participation, or is not in the best interest of thesubject to participate, in the opinion of the treating investigator
Females must not be currently breast feeding.
The treating investigator feels the patient is not able to be compliant.
History of active Bacillus Tuberculosis (TB).
Has received a live vaccine within 30 days of registration.
Prisoners or patients who are incarcerated.
Patients who are compulsorily detained for treatment of a psychiatric or physicalillness.
Study Design
Study Description
Connect with a study center
University of Virginia
Charlottesville, Virginia 22903
United StatesActive - Recruiting
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