OncoMatch/Clinical Trials/NCT05013216
Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer
Is NCT05013216 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cohort A: Patients at high risk of developing pancreatic cancer. and Cohort B: Patients must have evidence of a pancreatic cystic neoplasm for high risk cancer.
Treatment: Cohort A: Patients at high risk of developing pancreatic cancer. · Cohort B: Patients must have evidence of a pancreatic cystic neoplasm — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Biomarker criteria
Required: CDKN2A mutation
carrier of FAMMM (p16/CDKN2A) mutation
Required: BRCA2 mutation
carrier of a known BRCA2 mutation
Required: ATM mutation
carrier of a known ATM mutation
Required: PALB2 mutation
carrier of a known PALB2 mutation
Required: BRCA1 mutation
carrier of a known BRCA1 mutation
Required: MLH1 mutation
carrier of a known HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene mutation
Required: MSH2 mutation
carrier of a known HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene mutation
Required: PMS1 mutation
carrier of a known HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene mutation
Required: MSH6 mutation
carrier of a known HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene mutation
Required: EPCAM mutation
carrier of a known HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene mutation
Required: KRAS G12D, G12V, G12R, G12C, G12A, G13D
cystic fluid testing that demonstrates the presence of one of the six KRAS mutations included in the study vaccine
Prior therapy
Cannot have received: systemic or localized antineoplastic therapy
expected to require any other form of systemic or localized antineoplastic therapy while on study
Cannot have received: systemic or topical corticosteroids or immunosuppressive agents
Any systemic or topical corticosteroids at immunosuppressive agents within 4 weeks prior to first dose of study drug
Cannot have received: investigational device
Any investigational device within 4 weeks prior to first dose of study drug
Cannot have received: live vaccine
Has received a live vaccine within 4 weeks prior to first dose of study drug
Cannot have received: allergen hyposensitization therapy
Received any allergen hyposensitization therapy within 4 weeks prior to first dose of study drug
Cannot have received: major surgery
Any major surgery within 4 weeks prior to first dose of study drug
Lab requirements
Blood counts
adequate organ and marrow function defined by study-specified laboratory tests
Kidney function
adequate organ and marrow function defined by study-specified laboratory tests
Liver function
adequate organ and marrow function defined by study-specified laboratory tests
Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sidney Kimmel Comprehensive Cancer Center · Baltimore, Maryland
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