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NCT05111353 · ClinicalTrials.gov registry record · Phase 1
Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery
A Phase 1 study of Pancreatic Cancer and Pancreas Cancer, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT05111353: Completed Phase 1 study of Pancreatic Cancer and Pancreas Cancer, sponsored by Washington University School of Medicine.
NCT05111353 is a Phase 1 study of Pancreatic Cancer and Pancreas Cancer that has completed, run by Washington University School of Medicine. The registered enrollment target is 33 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05111353, a Phase 1 study of Pancreatic Cancer and Pancreas Cancer, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
-Adverse events will be characterized according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE).
Conditions Studied
Interventions
- BIOLOGICAL Poly-ICLC
- BIOLOGICAL Optimized neoantigen synthetic long peptide vaccine
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2022-12-15 |
| Est. Completion | 2025-11-03 |
| Phase | Phase 1 |
What the finished NCT05111353 record still lists
NCT05111353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 2 interventions - of which Poly-ICLC is the first listed.
NCT05111353 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05111353 about?
NCT05111353 is a clinical study titled "Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery". 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 ...
What is the current status of trial NCT05111353?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2022-12-15. Estimated completion is 2025-11-03.
What conditions does trial NCT05111353 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Pancreas Cancer, Cancer of the Pancreas.
What interventions are being tested in trial NCT05111353?
The interventions under investigation include: Poly-ICLC (BIOLOGICAL), Optimized neoantigen synthetic long peptide vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05111353?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05111353 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05111353's enrollment target sits among peer trials
33 183rd of 278 higher than 95 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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