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.
>/=55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and
Come from a family with 2 or more members with a history of pancreatic cancer (2 of which have a first-degree relationship consistent with familial pancreatic cancer), and
Have a first-degree relationship with at least one of the relatives with pancreatic cancer.
If there are 2 or more affected blood relatives, at least 1 must be a first-degree relative of the individual being screened.
If expected to require any other form of systemic or localized antineoplastic therapy while on study.
Within 4 weeks prior to first dose of study drug.
Within 4 weeks prior to first dose of study drug.
Any investigational device.
Sequential
Cohort A: Patients at high risk of developing pancreatic cancer.
Drug1. 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
Cohort B: Patients must have evidence of a pancreatic cystic neoplasm
DrugPatients 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).
Number of participants experiencing study drug-related toxicities
Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0
Maximal percentage of change of interferon (IFN-γ) producing mutant-KRAS-specific CD8 and CD4 T cells
Maximal percent change per patient within 17 weeks after vaccination.
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 5 weeks.
Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 5 weeks after vaccination compared to pre-vaccination baseline.
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 13 weeks.
Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 13 weeks after vaccination compared to pre-vaccination baseline.
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 17 weeks.
Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 17 (EOT) weeks after vaccination compared to pre-vaccination baseline.
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 1 weeks.
Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 5 weeks after vaccination compared to pre-vaccination baseline.
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 4 weeks.
Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 13 weeks after vaccination compared to pre-vaccination baseline.
Fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 8 weeks.
Evaluated by the fold change in interferon-producing mutant-KRAS-specific CD8 and CD4 T cells at 17 (EOT) weeks after vaccination compared to pre-vaccination baseline.
Click on the lead sponsor to view all of their trials.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Stand Up To Cancer
Collaborator
National Cancer Institute (NCI)
Collaborator
