Could a vaccine stop pancreatic cancer before it starts?
NCT ID NCT05013216
First seen Jun 24, 2026 · Last updated Jul 01, 2026 · Updated 4 times
Summary
This early-stage study tests a vaccine designed to train the immune system to attack cells with a mutated KRAS gene, which is common in pancreatic cancer. The vaccine is given to people at high risk due to family history or pancreatic cysts. The main goals are to see if the vaccine is safe and whether it triggers an immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KRAS peptide vaccine with poly-ICLC (Hiltonol) adjuvant
- What this could lead to
- If successful, this could lead to a vaccine that prevents pancreatic cancer in high-risk individuals.
- What could go wrong
- This is a very early phase 1 study with only 37 participants, so it's too soon to know if the vaccine works. Side effects are possible, and the immune response may not be strong enough to prevent cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 37 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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May 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Sidney Kimmel Comprehensive Cancer Center
RECRUITINGBaltimore, Maryland, 21231, United States
Contact Email: •••••@•••••
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Other studies related to the condition(s) this trial covers.
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- Can a new radiation machine cut breath holds for cancer patients?
- Two oral drugs join chemotherapy in a bid to shrink pancreatic tumors
- Nerve-Block procedure tested against severe pancreatic and stomach cancer pain