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

PHASE1RecruitingINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

April 11, 2022

Primary Completion Date

October 1, 2027

Study Completion Date

May 1, 2031

Conditions
High Risk CancerPancreatic Cancer
Interventions
DRUG

Cohort 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"

DRUG

Cohort 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).

Trial Locations (1)

21231

RECRUITING

Sidney Kimmel Comprehensive Cancer Center, Baltimore

All Listed Sponsors
collaborator

Stand Up To Cancer

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER