RecruitingPhase 1NCT05013216

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

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

37 participants

Start Date

Apr 11, 2022

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer High-Risk Cancer

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.

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests a vaccine targeting a mutant form of a protein called KRAS in people at high risk of developing pancreatic cancer. The goal is to see whether this vaccine can prevent or delay the development of pancreatic cancer in high-risk individuals. **You may be eligible if...** - You are at high risk for pancreatic cancer due to family history (2+ relatives with pancreatic cancer), or certain genetic mutations (BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, or others), or you have been told you carry a familial pancreatic cancer risk - You are currently undergoing pancreatic surveillance (regular monitoring scans) - Imaging has shown a pancreatic abnormality such as a cyst - You are at least 55 years old, or at least 10 years younger than the youngest affected family member **You may NOT be eligible if...** - You do not have documented high risk for pancreatic cancer - You have no pancreatic abnormality detected on imaging - You have been previously diagnosed with pancreatic cancer - You have a serious immune system condition or are taking immunosuppressive medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCohort A: Patients at high risk of developing pancreatic cancer.

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

DRUGCohort B: Patients must have evidence of a pancreatic cystic neoplasm

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).