NCT05111353

Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery

Completed Phase 1 Last updated 5 November 2025

What this trial tests

Phase 1 trial testing Optimized neoantigen synthetic long peptide vaccine in Pancreas Cancer in 33 participants. Completed in 3 November 2025.

Timeline

15 December 2022

Primary endpoint
3 November 2025

3 November 2025

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	15 December 2022
Primary completion	3 November 2025
Estimated completion	3 November 2025
Sites	1 location across United States

Drugs / interventions tested

• Optimized neoantigen synthetic long peptide vaccine — full drug profile →
• Poly-ICLC

Conditions studied

• Pancreas Cancer — all drugs for Pancreas Cancer →
• Pancreatic Cancer — all drugs for Pancreatic Cancer →
• Cancer of the Pancreas — all drugs for Cancer of the Pancreas →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Pancreas Cancer or Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neoantigens: promising targets for cancer therapy.
   Xie N, Shen G, Gao W, Huang Z, et al · · 2023 · cited 713× · PMID 36604431 · DOI 10.1038/s41392-022-01270-x
2. Personalized pancreatic cancer therapy: from the perspective of mRNA vaccine.
   Huang X, Zhang G, Tang TY, Gao X, et al · · 2022 · cited 61× · PMID 36224645 · DOI 10.1186/s40779-022-00416-w
3. Consensus, debate, and prospective on pancreatic cancer treatments.
   Wang J, Yang J, Narang A, He J, et al · · 2024 · cited 56× · PMID 39390609 · DOI 10.1186/s13045-024-01613-x
4. Neoantigen cancer vaccines: a new star on the horizon.
   Li X, You J, Hong L, Liu W, et al · · 2023 · cited 31× · PMID 38164734 · DOI 10.20892/j.issn.2095-3941.2023.0395
5. Engineering neoantigen vaccines to improve cancer personalized immunotherapy.
   Liu Z, Lv J, Dang Q, Liu L, et al · · 2022 · cited 30× · PMID 36263174 · DOI 10.7150/ijbs.76281
6. The role of neoantigens and tumor mutational burden in cancer immunotherapy: advances, mechanisms, and perspectives.
   Sun S, Liu L, Zhang J, Sun L, et al · · 2025 · cited 17× · PMID 40898324 · DOI 10.1186/s13045-025-01732-z
7. New Treatment Options in Metastatic Pancreatic Cancer.
   Fudalej M, Kwaśniewska D, Nurzyński P, Badowska-Kozakiewicz A, et al · · 2023 · cited 13× · PMID 37190255 · DOI 10.3390/cancers15082327
8. Overcoming Suppressive Tumor Microenvironment by Vaccines in Solid Tumor.
   Xie YJ, Liu WQ, Li D, Hou JC, et al · · 2023 · cited 13× · PMID 36851271 · DOI 10.3390/vaccines11020394