mDC3/8-KRAS Vaccine and Cyclophosphamide in Treating Patients with Resectable Stage I-III Pancreatic Cancer

Inclusion Criteria

• Pathologically-confirmed KRASG12D-, KRASG12V-, KRASG12R- or KRASG12C-mutated pancreatic ductal adenocarcinoma (PDA) who are at high risk of relapse and have no evidence of disease (NED). This includes stage I, II and III patients treated with surgery with or without neoadjuvant or adjuvant systemic chemotherapy and / or radiotherapy.
• Expression of one or more of the following HLA class I alleles: HLA-A02, HLA-A03, HLA-A11, HLA-B07 and HLA-C08.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• White blood cell > 3 THO/uL (performed within 14 days prior to consent).
• Hemoglobin (Hg) >= 9.0 gm/dl (performed within 14 days prior to consent).
• Platelets > 75 THO/uL (performed within 14 days prior to consent).
• Total bilirubin < 2.0 mg/dl (performed within 14 days prior to consent).
• Serum creatinine < 2.0 mg/dl (performed within 14 days prior to consent).
• Subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial.
• Provide written informed consent.

Exclusion Criteria

• Prior treatment with more than one line of cytotoxic chemotherapy. Prior treatment with one line of cytotoxic chemotherapy is permitted. Radiotherapy is not considered a line of therapy.
• Prior malignancy (except non-melanoma skin cancer) within 3 years.
• Pregnant or nursing (lactating) women
• Concurrent treatment with systemic immunosuppressants including corticosteroids (e.g. prednisone), calcineurin inhibitors (e.g. tacrolimus, cyclosporine), antiproliferative agents (e.g. mycophenolate mofetil, azathioprine) within 2 weeks of eligibility confirmation by investigator. Local (inhaled or topical) steroids or replacement dose prednisone (=< 10 mg daily) are permitted.
• Known chronic viral infections including hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
• Known allergy to eggs.
• Prior history of uveitis or autoimmune inflammatory eye disease.
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent.
• Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.