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Neoantigen DNA Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy

NCT03122106 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-10-10

Study results available
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Summary

This is a phase 1 open-label study to evaluate the safety and immunogenicity of a neoantigen DNA vaccine strategy in pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The neoantigen DNA vaccines will incorporate prioritized neoantigens and personalized mesothelin epitopes and will be administered with an electroporation device. The hypothesis of this study is that neoantigen DNA vaccines will be safe and capable of generating measurable neoantigen-specific CD4 and CD8 T cell responses.

Conditions

Interventions

BIOLOGICAL

Personalized neoantigen DNA vaccine

-Personalized polyepitope inserts integrating the prioritized neoantigens and mesothelin epitopes will be designed and then synthesized and cloned into the pING parent vector

DEVICE

TDS-IM Electrode Array System

-Ichor Medical Systems

PROCEDURE

Peripheral blood draws

-Enrollment, mid adjuvant chemotherapy, end of chemotherapy, week 1, week 5, week 9, week 13, week 17, week 21, week 25, and week 77

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • William Gillanders, M.D. · Washington University School of Medicine

  • Daniel Laheru, M.D. · Johns Hopkins School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-05
Primary Completion
2021-09-03
Completion
2022-08-13
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03122106 on ClinicalTrials.gov