Overview
This Phase 1 study will evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine with poly-ICLC adjuvant.
Eligibility
Inclusion Criteria:
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 with
pancreatic 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 familial pancreatic
cancer), and
- Have a first-degree relationship with at least one of the relatives with
pancreatic cancer.
- If there are 2 or more affected blood relatives, at least 1 must be a
first-degree relative of the individual being screened
- High Risk Group 2 (Germline mutation carriers with an associated with an estimated
lifetime risk of pancreatic cancer of ~10% or higher):
- >/=40 years old and the Patient is a carrier of FAMMM (p16/CDKN2A) mutation
regardless of family pancreas cancer history.
OR
- >/= 50 years old or 10 years younger than the age of the youngest relative with
pancreatic cancer, and the Patient is a carrier of a known BRCA2, ATM, PALB2 mutation.
- Persons with known genetic mutation should have proof of mutation status. Those who
had research-related genetic testing must have confirmation by a clinical
CLIA-certified laboratory.
o High Risk Group 3 (Germline mutation carriers with an associated with an estimated
lifetime risk of pancreatic cancer of ~5%):
- >/= 50 years old or 10 years younger than the age of the youngest relative with
pancreatic cancer, and
- The patient is a carrier of a known, BRCA1, or HNPCC (hereditary non-polyposis
colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene mutation,
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 who
had research-related genetic testing must have confirmation by a clinical
CLIA-certified laboratory.
- Patients must have a pancreatic imaging abnormality that is being followed by
pancreatic imaging surveillance (EUS and/or MRI and /or CT), such as a pancreatic cyst
consistent with an IPMN or parenchymal abnormalities consistent with PanIN.
- Patients must have adequate organ and marrow function defined by study-specified
laboratory 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 follow
contraceptive 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 antineoplastic therapy
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, uncontrolled
infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia,
metastatic cancer, or psychiatric illness/social situations that would limit
compliance with study requirements monoclonal antibody.
- Has a diagnosis of immunodeficiency.
- Any other sound medical, psychiatric, and/or social reason as determined by the
Investigator.
- Unwilling or unable to follow the study schedule for any reason.
- Are pregnant or breastfeeding.