Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT05013216 |
Recruitment Status :
Recruiting
First Posted : August 19, 2021
Last Update Posted : June 6, 2022
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Condition or disease | Intervention/treatment | Phase |
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High Risk Cancer Pancreatic Cancer | Drug: KRAS peptide vaccine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer |
Actual Study Start Date : | April 11, 2022 |
Estimated Primary Completion Date : | May 1, 2026 |
Estimated Study Completion Date : | May 1, 2026 |

Arm | Intervention/treatment |
---|---|
Experimental: KRAS peptide vaccine |
Drug: KRAS peptide vaccine
Other Name: Hiltonol® (Poly-ICLC) |
- Number of participants experiencing study drug-related toxicities [ Time Frame: 2 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: Baseline and 2 years ]Maximal percent change after vaccination compared to pre-vaccination baseline compared to end of study treatment.
- Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 5, 13 and 17 weeks. [ Time Frame: 5, 13, and 17 weeks ]Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 5, 13 and 17 (EOT) weeks after vaccination compare to pre-vaccination baseline.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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.
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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.
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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.
- 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.
- 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.
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Within 4 weeks prior to first dose of study drug.
o Any systemic or topical corticosteroids at immunosuppressive agents.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05013216
Contact: Trish Brothers, RN | 410-614-3644 | GIClinicalTrials@jhmi.edu | |
Contact: Joann Santmyer, RN | 410-614-3644 | GIClinicalTrials@jhmi.edu |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center | Recruiting |
Baltimore, Maryland, United States, 21231 | |
Contact: Trish Brothers, RN 410-614-3644 GIClinicalTrials@jhmi.edu | |
Contact: Joann Santmyer, RN 410-614-3644 GIClinicalTrials@jhmi.edu | |
Principal Investigator: Neeha Zaidi, MD |
Principal Investigator: | Neeha Zaidi, MD | Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Medical Institution |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
ClinicalTrials.gov Identifier: | NCT05013216 |
Other Study ID Numbers: |
J2177 IRB00288752 ( Other Identifier: Johns Hopkins Medical Institution ) |
First Posted: | August 19, 2021 Key Record Dates |
Last Update Posted: | June 6, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
KRAS Peptide Vaccine Neoantigen Vaccines Cancer Vaccines Immunotherapy Pancreatic Ductal Adenocarcinoma (PDAC) |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases |
Pancreatic Diseases Endocrine System Diseases Poly ICLC Interferon Inducers Immunologic Factors Physiological Effects of Drugs |