Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery

Phase 1

Active, not recruiting

• Conditions: Pancreas Cancer; Pancreatic Cancer; Cancer of the Pancreas
• Interventions: Biological: Optimized neoantigen synthetic long peptide vaccine; Biological: Poly-ICLC

• 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: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-11-08
• Study Start: 2022-12-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

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 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 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	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; * 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.
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; * 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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States