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

Trial ID: NCT05013216

Interventional - Phase 1 - Active, not recruiting

This Phase 1 study will evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine with poly-ICLC adjuvant for patients who have been identified to be at risk of developing pancreatic cancer.

Conditions

• High Risk Cancer
• Pancreatic Cancer

Interventions

• Cohort A: Patients at high risk of developing pancreatic cancer.
• Cohort B: Patients must have evidence of a pancreatic cystic neoplasm

Eligibility

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 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.
• Cohort A: 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.
• Cohort B: Patients must have clinical, radiographic, or histologic evidence of pancreatic cystic neoplasm with high-risk features warranting surgical resection per the discretion of the treating hepatobiliary surgeon.
• Cohort B: Patients must have cystic fluid testing that demonstrates the presence of one of the six KRAS mutations included in the study vaccine.
• 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.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Stand Up To Cancer, National Cancer Institute (NCI)

Source: ClinicalTrials.gov

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