Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery
Overview
- Phase
- Phase 1
- Intervention
- Optimized neoantigen synthetic long peptide vaccine
- Conditions
- Pancreas Cancer
- Sponsor
- Washington University School of Medicine
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Safety of neoantigen SLP vaccine as measured by number of subjects experiencing each type of adverse event
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
This is a randomized phase 1 clinical trial to evaluate the safety of an optimized neoantigen synthetic long peptide (SLP) vaccines in pancreatic cancer patients following neoadjuvant chemotherapy. The neoantigen SLP vaccines will incorporate prioritized neoantigens and will be co-administered with poly-ICLC. Patients will be randomized to one of two arms: Arm 1 (neoantigen vaccine following neoadjuvant chemotherapy and surgery) or Arm 2 (neoantigen vaccine following neoadjuvant chemotherapy in the window prior to surgery).
Those who are ineligible for vaccine administration including those whose disease progresses or recurs during neoadjuvant chemo or who are otherwise unable to complete surgical resection but who had a personalized neoantigen vaccine manufactured, or significant progress has been made as determined by treating physician, are permitted to receive vaccine injections on study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm 1: Vaccine given after neoadjuvant chemotherapy and surgery
* The neoantigen peptide vaccine will be manufactured during neoadjuvant chemotherapy. Institutional standard of care chemotherapy will be given. * Peptide and poly-ICLC will be administered intramuscularly on Days 1, 4, 8, 15, 22, 50, and 78 beginning approximately 1 month after surgery. Day 1 should begin approximately 1 month after surgery.
Intervention: Optimized neoantigen synthetic long peptide vaccine
Arm 1: Vaccine given after neoadjuvant chemotherapy and surgery
* The neoantigen peptide vaccine will be manufactured during neoadjuvant chemotherapy. Institutional standard of care chemotherapy will be given. * Peptide and poly-ICLC will be administered intramuscularly on Days 1, 4, 8, 15, 22, 50, and 78 beginning approximately 1 month after surgery. Day 1 should begin approximately 1 month after surgery.
Intervention: Poly-ICLC
Arm 2: Vaccine given after neoadjuvant chemotherapy but before surgery
* The neoantigen peptide vaccine will be manufactured during neoadjuvant chemotherapy. Institutional standard of care chemotherapy will be given. * Peptide and poly-ICLC will be administered intramuscularly on Days 1, 4, 8, 15, and 22 during the chemotherapy holiday, and Days 50 and 78 post-operatively. Optimal timing for Day 1 is 1 week after end of chemotherapy, but Day 1 may be given up to 3 weeks after end of chemotherapy.
Intervention: Optimized neoantigen synthetic long peptide vaccine
Arm 2: Vaccine given after neoadjuvant chemotherapy but before surgery
* The neoantigen peptide vaccine will be manufactured during neoadjuvant chemotherapy. Institutional standard of care chemotherapy will be given. * Peptide and poly-ICLC will be administered intramuscularly on Days 1, 4, 8, 15, and 22 during the chemotherapy holiday, and Days 50 and 78 post-operatively. Optimal timing for Day 1 is 1 week after end of chemotherapy, but Day 1 may be given up to 3 weeks after end of chemotherapy.
Intervention: Poly-ICLC
Outcomes
Primary Outcomes
Safety of neoantigen SLP vaccine as measured by number of subjects experiencing each type of adverse event
Time Frame: Through 4 weeks after completion of last vaccination (estimated to be 108 days)
-Adverse events will be characterized according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE).
Secondary Outcomes
- Immunogenicity of neoantigen peptide vaccine as measured by the the number of neoantigen-specific T cells (only Arm 1 and Arm 2)(Through approximately 2 years and 78 days)
- Immunogenicity of neoantigen peptide vaccine as measured by the phenotype of neoantigen-specific T cells (only Arm 1 and Arm 2)(Through approximately 2 years and 78 days)