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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05013216
Recruitment Status : Recruiting
First Posted : August 19, 2021
Last Update Posted : June 6, 2022
Sponsor:
Collaborator:
Stand Up To Cancer
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
This Phase 1 study will evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine with poly-ICLC adjuvant.

Condition or disease Intervention/treatment Phase
High Risk Cancer Pancreatic Cancer Drug: KRAS peptide vaccine Phase 1

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: KRAS peptide vaccine Drug: KRAS peptide vaccine
  1. KRAS peptide vaccine will be administered on Prime week 1, 3, and 5. Boost vaccinations with will be administered at week 13.
  2. Drug: up to 1.8 mg KRAS peptide vaccine + 0.5mg Poly-ICLC
Other Name: Hiltonol® (Poly-ICLC)




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

  • 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.
  • 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.
  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Trish Brothers, RN 410-614-3644 GIClinicalTrials@jhmi.edu
Contact: Joann Santmyer, RN 410-614-3644 GIClinicalTrials@jhmi.edu

Locations
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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         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Stand Up To Cancer
Investigators
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Principal Investigator: Neeha Zaidi, MD Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Medical Institution
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
KRAS Peptide Vaccine
Neoantigen Vaccines
Cancer Vaccines
Immunotherapy
Pancreatic Ductal Adenocarcinoma (PDAC)
Additional relevant MeSH terms:
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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