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Recruiting NCT05013216

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

Conditions: High Risk Cancer, Pancreatic Cancer

Sex: All
Ages: 40 Years – N/A
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 37
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Location: Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland

Summary

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05013216). StuddyBuddy aggregates publicly available trial information.