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Immunologic Factors

* 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.

* 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.

Neoantigen vaccines will be provided on a patient-specific basis

Optimized neoantigen synthetic long peptide vaccine

Poly-ICLC will be supplied by Oncovir, Inc.

Poly-ICLC

William E Gillanders, M.D.

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.

Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery

Sequencing data will be submitted to the database of Genotypes and Phenotypes (dbGap) at the National Cancer Institute.

-Adverse events will be characterized according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE).

* 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
* Immune monitoring will occur at baseline, day 1, day 15, day 22, at the time of surgery, and day 78 for Arm 2. Optional monitoring at 1 and 2 years after last vaccine administration.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery	NCT05111353	Pancreas Cancer Pancreatic Canc... Cancer of the P...	Optimized neoan... Poly-ICLC	18 Years -	Washington University School of Medicine
Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery	NCT05111353	Pancreas Cancer Pancreatic Canc... Cancer of the P...	Optimized neoan... Poly-ICLC	18 Years -	Washington University School of Medicine

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