Mutant Kirsten Rat Sarcoma (KRAS) -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 1 study will evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine with poly-ICLC adjuvant.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Stand Up To Cancer
• Treatments: Poly ICLC

Criteria

Inclusion Criteria:

Must fall into one of the three categories defined as high risk of developing pancreatic cancer:

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

• older than 55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and

• Have 2 or more family members with a history of pancreatic cancer, and

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

• High Risk Group 2 (Has gene mutation(s) with an associated with an estimated lifetime risk of pancreatic cancer of approximately 10% or higher):

• 50 years old and has FAMMM (p16/CDKN2A) gene mutation.

• older than 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and

• Has known BRCA2, Acute Transverse Myelopathy (ATM), partner and localizer of BRCA2 (PALB2) gene mutation, and

• There is more than 1 pancreatic cancer in the family, one of whom is a first- or second-degree relative of the subject to be screened.

• High Risk Group 3 (Has gene mutation(s) with an associated with an estimated lifetime risk of pancreatic cancer of approximately 5%):

• Older than 55 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and

• Has known BRCA1, or HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, postmeiotic segregation 1(PMS1), human MutS homolog 6 (hMSH6), EpCAM) gene mutations, and

• There is more than 1 pancreatic cancer in the family, one of whom is a first- or second-degree relative of the subject to be screened.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• 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.