At a glance
ClinicalIndex Comparison Record- ✓High Risk Group 1: Age ≥55 or 10 years younger than youngest relative with pancreatic cancer, from family with ≥2 pancreatic cancer members (2 with first-degree relationship), and first-degree relative to at least one affected relative
- ✓High Risk Group 2: Age ≥40 with FAMMM (p16/CDKN2A) mutation, OR age ≥50 or 10 years younger than youngest relative with pancreatic cancer and carrier of BRCA2, ATM, or PALB2 mutation
- ✓High Risk Group 3: Age ≥50 or 10 years younger than youngest relative with pancreatic cancer, carrier of BRCA1 or HNPCC mutation (hMLH1, hMSH2, PMS1, hMSH6, EpCAM), and >1 pancreatic cancer in family with ≥1 first- or second-degree relative to subject
- ✓Genetic mutation carriers must have proof of mutation status; research-related genetic testing must be confirmed by clinical CLIA-certified laboratory
- ✕Expected to require any other form of systemic or localized antineoplastic therapy while on study
- ✕Any systemic or topical corticosteroids or immunosuppressive agents within 4 weeks prior to first dose
- ✕Any investigational device within 4 weeks prior to first dose
- ✕Received a live vaccine
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer
In Brief
A Phase 1 clinical trial evaluating 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 and Pancreatic Cancer. Currently recruiting, targeting 37 participants across 1 site.
Detailed 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.
Study Details
Timeline
Arms & Interventions
Patients will include those who have undergone pancreatic imaging with MRI or CT or EUS and found to have one or more pancreatic imaging abnormalities such as a pancreatic cyst consistent with an intraductal papillary mucinous neoplasm (IPMN) or parenchymal changes consistent with pancreatic intraepithelial neoplasia (PanIN). additionally patients with: 1. familial pancreatic cancer relatives 2. germline mutation carriers with an estimated lifetime risk of pancreatic cancer of \~10% or higher 3. germline mutation carriers with an estimated lifetime risk of pancreatic cancer of \~5%, all detailed in Section 3.1.1. These patients must also (as defined in Section 3.1.2).
Patients must have clinical, radiographic, or histologic evidence of a pancreatic cystic neoplasm with high-risk features warranting surgical resection per the discretion of the treating hepatobiliary surgeon. In addition, cyst fluid analysis must demonstrate the presence of one of the six KRAS mutations included in the study vaccine. Germline mutation testing or a positive family history of pancreatic cancer is not required for enrollment in Cohort B.
Interventions
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
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).