Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer

Inclusion Criteria:

Cohort A: Must fall into one of the three categories defined as high risk of developing pancreatic cancer and are undergoing pancreatic surveillance AND 2) have documented radiographic evidence of a pancreatic abnormality such as a pancreatic cyst.

• High Risk Group 1 (familial pancreatic cancer relatives):

• >/=55 years old or 10 years younger than the age of youngest relative withpancreatic cancer, and

• Come from a family with 2 or more members with a history of pancreatic cancer (2 of which have a first-degree relationship consistent with familialpancreatic cancer), and

• Have a first-degree relationship with at least one of the relatives withpancreatic cancer.

• If there are 2 or more affected blood relatives, at least 1 must be afirst-degree relative of the individual being screened.

• High Risk Group 2 (Germline mutation carriers with an associated with an estimatedlifetime risk of pancreatic cancer of ~10% or higher):

• >/=40 years old and the Patient is a carrier of FAMMM (p16/CDKN2A) mutationregardless of family pancreas cancer history.

OR

• >/= 50 years old or 10 years younger than the age of the youngest relative withpancreatic cancer, and the Patient is a carrier of a known BRCA2, ATM, PALB2mutation.

• Persons with known genetic mutation should have proof of mutation status. Those whohad research-related genetic testing must have confirmation by a clinicalCLIA-certified laboratory. o High Risk Group 3 (Germline mutation carriers with an associated with an estimatedlifetime risk of pancreatic cancer of ~5%):

• >/= 50 years old or 10 years younger than the age of the youngest relative withpancreatic cancer, and

• The patient is a carrier of a known, BRCA1, or HNPCC (hereditary non-polyposiscolorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) genemutation, and there is > 1 pancreatic cancer in the family, one of whom is a first-or second-degree relative of the subject to be screened.

• Persons with known genetic mutation should have proof of mutation status. Those whohad research-related genetic testing must have confirmation by a clinicalCLIA-certified laboratory.

• Cohort A: Patients must have a pancreatic imaging abnormality that is being followedby pancreatic imaging surveillance (EUS and/or MRI and /or CT), such as a pancreaticcyst consistent with an IPMN or parenchymal abnormalities consistent with PanIN.

• Cohort B: Patients must have clinical, radiographic, or histologic evidence ofpancreatic cystic neoplasm with high-risk features warranting surgicalresection per the discretion of the treating hepatobiliary surgeon.

• Cohort B: Patients must have cystic fluid testing that demonstrates thepresence of one of the six KRAS mutations included in the study vaccine.

• Patients must have adequate organ and marrow function defined by study-specifiedlaboratory tests prior to initial study drug.

• Ability to understand and willingness to sign a written informed consent document.

• Woman of childbearing potential must have a negative pregnancy test and followcontraceptive guidelines as defined per protocol.

• Men must use acceptable form of birth control while on study.

Exclusion Criteria:

• If expected to require any other form of systemic or localized antineoplastictherapy while on study.

• Within 4 weeks prior to first dose of study drug. o Any systemic or topical corticosteroids at immunosuppressive agents.

• Within 4 weeks prior to first dose of study drug.

• Any investigational device.

• Has received a live vaccine.

• Received any allergen hyposensitization therapy.

• Any major surgery.

• Infection with HIV or hepatitis B or C.

• Uncontrolled intercurrent illness including, but not limited to, uncontrolledinfection, symptomatic congestive heart failure, unstable angina, cardiacarrhythmia, metastatic cancer, or psychiatric illness/social situations that wouldlimit compliance with study requirements monoclonal antibody.

• Has a diagnosis of immunodeficiency.

• Any other sound medical, psychiatric, and/or social reason as determined by theInvestigator.

• Unwilling or unable to follow the study schedule for any reason.

• Are pregnant or breastfeeding.