Actively Recruiting
Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-12-03
37
Participants Needed
1
Research Sites
472 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
S
Stand Up To Cancer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be at least 40 years old
- Cohort A: High risk of developing pancreatic cancer with pancreatic surveillance and documented pancreatic abnormality such as a pancreatic cyst
- High Risk Group 1: Age 55 or older (or 10 years younger than youngest affected relative), family with 2 or more pancreatic cancer cases with at least one first-degree relative affected
- High Risk Group 2: Age 40 or older and carrier of FAMMM mutation; or age 50 or older (or 10 years younger than youngest affected relative) and carrier of BRCA2, ATM, or PALB2 mutation
- High Risk Group 3: Age 50 or older (or 10 years younger than youngest affected relative) and carrier of BRCA1 or Lynch syndrome gene mutation with more than one pancreatic cancer case in family
- Cohort A patients must have pancreatic imaging abnormalities under surveillance such as cysts consistent with IPMN or PanIN
- Cohort B: Evidence of pancreatic cystic neoplasm with high-risk features needing surgery
- Cohort B: Cystic fluid testing positive for one of the six KRAS mutations in the vaccine
- Adequate organ and marrow function based on lab tests
- Ability to understand and willingness to sign informed consent
- Women of childbearing potential must have negative pregnancy test and follow contraceptive guidelines
- Men must use acceptable birth control during study
You will not qualify if you...
- Expected to require other systemic or localized anti-cancer therapy during study
- Use of systemic or topical corticosteroids or immunosuppressive agents within 4 weeks before first dose
- Use of investigational device within 4 weeks before first dose
- Received live vaccine or allergen hyposensitization therapy within 4 weeks before first dose
- Underwent major surgery within 4 weeks before first dose
- Infection with HIV or hepatitis B or C
- Uncontrolled illness including infection, heart failure, unstable angina, arrhythmia, metastatic cancer, or psychiatric/social conditions limiting compliance
- Diagnosis of immunodeficiency
- Any other significant medical, psychiatric, or social reason determined by investigator
- Unwilling or unable to follow study schedule
- Pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
Actively Recruiting
Research Team
C
Colleen Apostol, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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