Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery
- Conditions
- Interventions
- Registration Number
- NCT05111353
- Lead Sponsor
- Washington University School of Medicine
- 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: A...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Vaccine given after neoadjuvant chemotherapy and surgery Optimized neoantigen synthetic long peptide vaccine * 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. Arm 1: Vaccine given after neoadjuvant chemotherapy and surgery Poly-ICLC * 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. Arm 2: Vaccine given after neoadjuvant chemotherapy but before surgery Optimized neoantigen synthetic long peptide vaccine * 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. Arm 2: Vaccine given after neoadjuvant chemotherapy but before surgery Poly-ICLC * 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.
- Primary Outcome Measures
Name Time Method Safety of neoantigen SLP vaccine as measured by number of subjects experiencing each type of adverse event 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 Outcome Measures
Name Time Method 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 * Immune monitoring will occur at baseline, at time of surgery, day 1, day 15, day 22, and day 78 for Arm 1. Optional monitoring at 1 and 2 years after last vaccine administration
...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 * Immune monitoring will occur at baseline, at time of surgery, day 1, day 15, day 22, and day 78 for Arm 1. Optional monitoring at 1 and 2 years after last vaccine administration
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Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States