CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02780401
NCT02780401Phase 1Completed
CompareCT.gov

A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine (WOKVAC) Encoding Epitopes Derived From Three Breast Cancer Antigens (IGFBP-2, HER2, and IGF-1R) in Patients With Breast Cancer

University of Washington·interventional·Posted May 23, 2016·Updated Sep 19, 2024

In Brief

A Phase 1 clinical trial evaluating Laboratory Biomarker Analysis, pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine, and 1 other intervention for HER2/Neu Negative and 10 related conditions. Completed, enrolled 32 participants across 2 sites.

Detailed Summary

This phase I trial studies the side effects and best dose of a vaccine therapy in preventing cancer from coming back in patients with non-metastatic, node positive, human epidermal growth factor receptor (HER)2 negative breast cancer in which all signs and symptoms have disappeared. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill tumor cells. Giving multiple vaccinations may make a stronger immune response and prevent or delay the return of cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHER2/Neu Negative, No Evidence of Disease, One or More Positive Axillary Nodes, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), University of Wisconsin, Madison

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 23, 2016
Enrollment StartSep 2, 2016
Primary CompletionOct 8, 2020
Study CompletionOct 8, 2022
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.1 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccinebiological

Given ID

Sargramostimbiological

Given ID