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TDS-IM Electrode Array System for Pancreatic Cancer

Phase 1
Waitlist Available
Led By William Gillanders, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through week 77
Awards & highlights

Study Summary

This trial will test a vaccine for pancreatic cancer patients who have had surgery and chemotherapy. The vaccine contains DNA that codes for proteins that are found only on cancer cells. The hypothesis is that the vaccine will be safe and will cause the body to make immunity cells that will attack cancer cells.

Eligible Conditions
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 77
This trial's timeline: 3 weeks for screening, Varies for treatment, and through week 77 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
Secondary outcome measures
Immunogenicity of the Neoantigen DNA Vaccine as Measured by ELISPOT Analysis
Immunogenicity of the Neoantigen DNA Vaccine as Measured by Multiparametric Flow Cytometry

Trial Design

1Treatment groups
Experimental Treatment
Group I: Personalized neoantigen DNA vaccineExperimental Treatment3 Interventions
Vaccines will be weeks 1, 5, 9, 13, 17, and 21. Vaccines will occur within +/- 1 week with at least 3 weeks between vaccines. All study injections will be given intramuscularly using TDS-IM system. At each vaccination time point, patients will receive 2 injections of the neoantigen DNA vaccine, 1 injection into each deltoid or lateralis. Minimum observation of 30 minutes. Vital signs will be taken at 30-45 minutes post-immunization. The injection sites will be inspected for evidence of local reaction. Follow up on subject well-being will be performed by telephone on the 1st or 2nd day following each injection. -Post-vaccination follow-up visits are at Week 25 ± 7 days and Week 77 ± 14 days. Additional follow-up visits or telephone contact will be scheduled at Week 129 and annually thereafter if the patient is alive and available for follow-up. At intervals throughout the study (both before and after vaccination) subjects will have blood drawn for immunologic assays.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peripheral blood draws
2017
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,151 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,687 Total Patients Enrolled
William Gillanders, M.D.Principal InvestigatorWashington University School of Medicine
3 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Neoantigen DNA Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
2018. "Neoantigen DNA Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03122106.
~2 spots leftby Apr 2025
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