High Risk CancerPhase 1NCT05013216

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

A Phase 1 study testing Cohort A: Patients at high risk of developing pancreatic cancer. and Cohort B: Patients must have evidence of a pancreatic cystic neoplasm in people with High Risk Cancer and Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for: High Risk Cancer, Pancreatic Cancer
What is being tested?: Cohort A: Patients at high risk of developing pancreatic cancer. and Cohort B: Patients must have evidence of a pancreatic cystic neoplasm
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 11 Apr 2022to 1 May 2031
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231

Other trials in United States

About this study

Read the detailed description

This study will evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine (KRAS peptide vaccine) with poly-ICLC adjuvant. The primary endpoints of this study are to determine the safety of administering the KRAS peptide vaccine with poly-ICLC adjuvant and to assess the maximal percent change of IFN-γ-producing mutant-KRAS-specific T cells per patient at any time after vaccination. Twenty five patients will be enrolled to achieve 20 evaluable patients for Cohort A. Twelve patients will be enrolled to achieve 10 evaluable patients for Cohort B.

For all patients, the study will consist of a screening phase, treatment phase, and a follow-up visit. All subjects will have the option remaining on study with annual follow-up visits that begin approximately one year after the last vaccine dose and continue annually thereafter until study closure.

Conditions: High Risk Cancer, Pancreatic Cancer
Being tested: Cohort A: Patients at high risk of developing pancreatic cancer., Cohort B: Patients must have evidence of a pancreatic cystic neoplasm
Keywords: KRAS Peptide Vaccine, Neoantigen Vaccines, Cancer Vaccines, Immunotherapy, Pancreatic Ductal Adenocarcinoma (PDAC)
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cohort A: Patients at high risk of developing pancreatic cancer.Drug
Also called Hiltonol® (Poly-ICLC)
1. KRAS peptide vaccine with poly-ICLC adjuvant will be administered on Prime week 1, 3, and 5. Boost vaccinations with will be administered at week 13. All subjects will return to the study site approximately 28 days (+ 7 days) after the last vaccination for an End of Treatment (EOT) and safety evaluation.
2. Drug: up to 1.8 mg KRAS peptide vaccine + 0.5mg Poly-ICLC
Cohort B: Patients must have evidence of a pancreatic cystic neoplasmDrug
Also called Hiltonol® (Poly-ICLC)
Patients will receive KRAS peptide vaccine with poly-ICLC adjuvant as two prime vaccinations on weeks 1 and 2. Surgery is considered standard of care. Surgery will occur at the discretion of the treating hepatobiliary surgeon and is not dictated by this protocol. Subjects will return to the study site approximately at week 4 (+ 7 days) for a safety evaluation prior to surgery. Subjects will have an End of Treatment (EOT) visit at study Week 8 (+ 7 days).

Study groups in NCT05013216
Study group	Role	What they receive
Cohort A: Patients at high risk of developing pancreatic cancer.	Experimental	Patients will include those who have undergone pancreatic imaging with MRI or CT or EUS and found to have one or more pancreatic imaging abnormalities such as a pancreatic cyst consistent with an intraductal papillary mucinous neoplasm (IPMN) or parenchymal changes consistent with pancreatic intraepithelial neoplasia (PanIN). additionally patients with: 1. familial pancreatic cancer relatives 2. germline mutation carriers with an estimated lifetime risk of pancreatic cancer of ~10% or higher 3. germline mutation carriers with an estimated lifetime risk of pancreatic cancer of ~5%, all detailed in Section 3.1.1. These patients must also (as defined in Section 3.1.2). Receives: Drug: Cohort A: Patients at high risk of developing pancreatic cancer.
Cohort B: Patients must have evidence of a pancreatic cystic neoplasm	Experimental	Patients must have clinical, radiographic, or histologic evidence of a pancreatic cystic neoplasm with high-risk features warranting surgical resection per the discretion of the treating hepatobiliary surgeon. In addition, cyst fluid analysis must demonstrate the presence of one of the six KRAS mutations included in the study vaccine. Germline mutation testing or a positive family history of pancreatic cancer is not required for enrollment in Cohort B. Receives: Drug: Cohort B: Patients must have evidence of a pancreatic cystic neoplasm

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants experiencing study drug-related toxicities
Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0
Measured: 1.5 years
Maximal percentage of change of interferon (IFN-γ) producing mutant-KRAS-specific CD8 and CD4 T cells
Maximal percent change per patient within 17 weeks after vaccination.
Measured: 17 weeks

Secondary outcomes (3)

Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 5 weeks.
Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 5 weeks after vaccination compared to pre-vaccination baseline.
Measured: Baseline, 5 weeks (Cohort A)
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 13 weeks.
Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 13 weeks after vaccination compared to pre-vaccination baseline.
Measured: Baseline, 13 weeks (Cohort A)
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 17 weeks.
Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 17 (EOT) weeks after vaccination compared to pre-vaccination baseline.
Measured: Baseline,17 weeks (Cohort A)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Apr 20221 May 2031

First posted19 Aug 2021
Study start11 Apr 2022
Primary completion1 Oct 2027 (estimated)
Study completion1 May 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for High Risk CancerStudies of the same condition, open and under way.
More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05013216
Sponsor's protocol ID: J2177
Other IDs: IRB00288752
Status last verified: Oct 2026
First submitted: 18 Aug 2021
Last updated: 6 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer
ClinicalTrials.gov ID: NCT05013216
Acronym / sponsor ID: J2177
Conditions: High Risk Cancer, Pancreatic Cancer
Keywords: KRAS Peptide Vaccine, Neoantigen Vaccines, Cancer Vaccines, Immunotherapy, Pancreatic Ductal Adenocarcinoma (PDAC)
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 31 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
Collaborators: Stand Up To Cancer, National Cancer Institute (NCI)
Study start: 11 Apr 2022 (actual)
Primary completion: 1 Oct 2027 (estimated)
Study completion: 1 May 2031 (estimated)
First posted: 19 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort A: Patients at high risk of developing pancreatic cancer.	Experimental	Drug: Cohort A: Patients at high risk of developing pancreatic cancer.Patients will include those who have undergone pancreatic imaging with MRI or CT or EUS and found to have one or more pancreatic imaging abnormalities such as a pancreatic cyst consistent with an intraductal papillary mucinous neoplasm (IPMN) or parenchymal changes consistent with pancreatic intraepithelial neoplasia (PanIN). additionally patients with: 1. familial pancreatic cancer relatives 2. germline mutation carriers with an estimated lifetime risk of pancreatic cancer of ~10% or higher 3. germline mutation carriers with an estimated lifetime risk of pancreatic cancer of ~5%, all detailed in Section 3.1.1. These patients must also (as defined in Section 3.1.2).
Cohort B: Patients must have evidence of a pancreatic cystic neoplasm	Experimental	Drug: Cohort B: Patients must have evidence of a pancreatic cystic neoplasmPatients must have clinical, radiographic, or histologic evidence of a pancreatic cystic neoplasm with high-risk features warranting surgical resection per the discretion of the treating hepatobiliary surgeon. In addition, cyst fluid analysis must demonstrate the presence of one of the six KRAS mutations included in the study vaccine. Germline mutation testing or a positive family history of pancreatic cancer is not required for enrollment in Cohort B.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

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):
High Risk Group 2 (Germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~10% or higher):
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.

Key exclusion criteria (14 listed)

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.
Infection with HIV or hepatitis B or C.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cohort A: Patients at high risk of developing pancreatic cancer.Also: Hiltonol® (Poly-ICLC)1. KRAS peptide vaccine with poly-ICLC adjuvant will be administered on Prime week 1, 3, and 5. Boost vaccinations with will be administered at week 13. All subjects will return to the study site approximately 28 days (+ 7 days) after the last vaccination for an End of Treatment (EOT) and safety evaluation. 2. Drug: up to 1.8 mg KRAS peptide vaccine + 0.5mg Poly-ICLC	Drug	Cohort A: Patients at high risk of developing pancreatic cancer.
Cohort B: Patients must have evidence of a pancreatic cystic neoplasmAlso: Hiltonol® (Poly-ICLC)Patients will receive KRAS peptide vaccine with poly-ICLC adjuvant as two prime vaccinations on weeks 1 and 2. Surgery is considered standard of care. Surgery will occur at the discretion of the treating hepatobiliary surgeon and is not dictated by this protocol. Subjects will return to the study site approximately at week 4 (+ 7 days) for a safety evaluation prior to surgery. Subjects will have an End of Treatment (EOT) visit at study Week 8 (+ 7 days).	Drug	Cohort B: Patients must have evidence of a pancreatic cystic neoplasm

Primary outcome

Number of participants experiencing study drug-related toxicities
Time frame: 1.5 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 cells
Time frame: 17 weeks
Maximal percent change per patient within 17 weeks after vaccination.

3 secondary outcomes

Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 5 weeks.
Time frame: Baseline, 5 weeks (Cohort A)
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 13 weeks.
Time frame: Baseline, 13 weeks (Cohort A)
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 17 weeks.
Time frame: Baseline,17 weeks (Cohort A)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nilofer Azad, MD principal investigator

Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Medical Institution

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants experiencing study drug-related toxicities (time frame: 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05013216.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.