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Cancer Vaccine

KRAS Peptide Vaccine for Pancreatic Cancer

Phase 1

Recruiting

Led By Nilofer Azad, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new cancer vaccine made from mutated KRAS proteins and an adjuvant. They will study how safe it is and if it causes an immune response.

Who is the study for?

This trial is for adults at high risk of developing pancreatic cancer due to genetic mutations or family history. Participants must have a documented pancreatic abnormality and adequate organ function. Women of childbearing potential and men must follow contraceptive guidelines. Exclusions include pregnancy, breastfeeding, major surgery, infections like HIV or hepatitis B/C, immunodeficiency, recent receipt of vaccines or corticosteroids.

What is being tested?

The study tests the safety and immune response to a KRAS peptide vaccine with poly-ICLC adjuvant in individuals who are genetically predisposed to pancreatic cancer. It's an early-phase trial designed to see if this vaccine can potentially prevent the development of cancer in those at high risk.

What are the potential side effects?

As it's a Phase 1 study primarily assessing safety, specific side effects aren't listed but may include typical vaccine reactions such as soreness at injection site, fever, fatigue or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I carry a gene mutation linked to a high risk of pancreatic cancer.

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My organ and bone marrow functions meet the required levels for the study.

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I am over 40 with a FAMMM mutation or over 50 with a BRCA2, ATM, PALB2 mutation and have proof.

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I am at high risk for pancreatic cancer and have a pancreatic cyst.

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I am being monitored for a pancreatic issue with regular scans.

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I am not pregnant and will follow the study's birth control requirements.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am infected with HIV or hepatitis B or C.

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I do not have any severe illnesses that my doctors are still trying to get under control.

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I have received a live vaccine recently.

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I have been diagnosed with an immune system disorder.

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I have undergone major surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximal percentage of change of interferon (IFN-γ) producing mutant-KRAS-specific CD8 and CD4 T cells

Number of participants experiencing study drug-related toxicities

Secondary study objectives

Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 13 weeks.

Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 17 weeks.

Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 5 weeks.

Other study objectives

Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 1 weeks.

Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 4 weeks.

Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 8 weeks.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B: Patients must have evidence of a pancreatic cystic neoplasmExperimental Treatment1 Intervention

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.

Group II: Cohort A: Patients at high risk of developing pancreatic cancer.Experimental Treatment1 Intervention

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).

0 / 11Eligibility criteria met