NCT07495124

IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence

A Phase II Study of (IGFBP-2) Vaccine to Prevent Progression After Serologic Detection of Recurrent Ovarian Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well giving the insulin-like growth factor binding protein 2 \[pUMVC3-hIGFBP-2 multi-epitope plasmid deoxyribonucleic acid (DNA) (IGFBP-2)\] vaccine after one dose of carboplatin works to stop ovarian cancer from growing, spreading, or getting worse (progressing) in patients whose cancer recurrence is detected only in the blood (serologic detection) following treatment with platinum chemotherapy. IGFBP-2 is a protein found in ovarian cancer cells. The IGFBP-2 vaccine may help the body build an effective immune response to kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It has been shown to activate parts of the immune system that may act against tumors. Giving the IGFBP-2 vaccine after a single dose of carboplatin may be an effective way to stop ovarian cancer from progressing in patients with serologic detection following treatment with platinum chemotherapy.

Detailed description

OUTLINE: Patients receive a single dose of carboplatin intravenously (IV) per standard of care on day -3 or -2 prior to cycle 1. Patients then receive IGFBP-2 vaccine intradermally on day 1 of each cycle. Cycles repeat every 4 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients who complete the original vaccine series may be eligible for up to an additional 3 IGFBP-2 vaccines, after another dose of carboplatin, 18 months after first vaccination. Additionally, patients undergo blood sample collection, computed tomography (CT), and/or magnetic resonance imaging (MRI) throughout the study. After completion of study treatment, patients are followed up at 4 weeks, every 4 weeks for 1 year, and then every 6 months for 2 years.

Conditions

• Fallopian Tube Carcinoma
• Ovarian Carcinoma
• Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine	Given intradermally
DRUG	Carboplatin	Given IV
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Biospecimen Collection	Undergo blood sample collection

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-09-29
• Completion: 2028-09-30
• First posted: 2026-03-27
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study