NCT04329065

Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer

A Phase II Study of Concurrent WOKVAC Vaccination With Neoadjuvant Chemotherapy and HER2-Targeted Monoclonal Antibody Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the immunologic response and side effects of using the WOKVAC vaccine in combination with chemotherapy and HER2-targeted monoclonal antibody therapy before surgery in treating patients with breast cancer. Vaccines like WOKVAC are made from tumor-associated antigens which may help the body build an effective immune response to kill tumor cells. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are forms of targeted therapy because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab and pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving the WOKVAC vaccine at the same time (concurrently) with paclitaxel, trastuzumab, and pertuzumab before surgery may kill more tumor cells.

Detailed description

OUTLINE: Patients receive WOKVAC intradermally (ID) on day 13. Treatment repeats for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive paclitaxel via infusion on days 1, 8, and 15 or docetaxel intravenously (IV) and carboplatin IV on day 1, and trastuzumab IV and pertuzumab IV on day 1. The chemo and trastuzumab and pertuzumab will most likely be given by the patient's own oncologist per standard of care. Treatment repeats for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound imaging or magnetic resonance imaging and biopsy on study and blood sample collection throughout the study. After completion of study treatment, patients are followed up annually for up to 5 years from enrollment.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine	Given ID
DRUG	Paclitaxel	Given via infusion
BIOLOGICAL	Trastuzumab	Given IV
BIOLOGICAL	Pertuzumab	Given IV
DRUG	Docetaxel	Given IV
DRUG	Carboplatin	Given IV
PROCEDURE	Ultrasound Imaging	Undergo ultrasound imaging
PROCEDURE	Biopsy Procedure	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection

Timeline

• Start date: 2022-04-20
• Primary completion: 2026-08-15
• Completion: 2027-08-15
• First posted: 2020-04-01
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study