KRAS Peptide Vaccine for High-Risk Pancreatic Cancer
This study is testing a vaccine called KRAS peptide vaccine with poly-ICLC adjuvant for people at high risk of developing pancreatic cancer. It aims to see if the vaccine is safe and how well it helps your immune system (specifically, your T cells) recognize and fight cells with the mutant KRAS biomarker. You might be eligible if you are at high risk for pancreatic cancer, possibly due to family history or a pancreatic abnormality like a cyst. The study will measure side effects and changes in your immune cells. This study is currently recruiting about 37 participants.
- Study design
- This is an interventional study with two groups (Cohort A and Cohort B) and plans to enroll 37 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will receive vaccinations over several weeks, with follow-up visits. Some participants may also have surgery as part of their standard care.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will have an End of Treatment visit about 28 days after the last vaccination. They also have the option to remain on study with annual follow-up visits until the study closes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05013216
Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer
Recruiting
PHASE1Ages 40+InterventionalPreventionSidney Kimmel Comprehensive Cancer Center at Johns HopkinsInvestigator-initiated
~37 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Cohort A: Patients at high risk of developing pancreatic cancer.Cohort B: Patients must have evidence of a pancreatic cystic neoplasm
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants experiencing study drug-related toxicities
Measured over 1.5 years
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Nilofer Azad, MD · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Medical Institution
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
\>/= 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.
\>/= 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
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.
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.
What this trial measures
- Number of participants experiencing study drug-related toxicities1.5 years
Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0
- Maximal percentage of change of interferon (IFN-γ) producing mutant-KRAS-specific CD8 and CD4 T cells17 weeks
Maximal percent change per patient within 17 weeks after vaccination.