IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Part of paid clinical trials in Seattle, Washington.
- Sponsor
- University of Washington
- Study ID
- NCT07495124
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Fallopian Tube Carcinoma
- Ovarian Carcinoma
- Primary Peritoneal Carcinoma
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine — BIOLOGICALGiven intradermally
- Carboplatin — DRUGGiven IV
- Computed Tomography — PROCEDUREUndergo CT
- Magnetic Resonance Imaging — PROCEDUREUndergo MRI
- Biospecimen Collection — PROCEDUREUndergo blood sample collection
Study Details
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.
Key Dates
- Start date
- Jul 1, 2026
- Status verified
- Mar 2026
- Primary completion
- Sep 29, 2027
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 26 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (carboplatin, IGFBP-2 vaccine)Patients receive a single dose carboplatin IV per standard of care on day -3 or -2 of 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, CT, and/or MRI throughout the study.
Primary Outcome Measure
Progression free survival [ Time Frame: At 6 months ]
Central Contacts
- CVI Coordinators1-866-932-8588
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | John Liao, MD, PhD (PRINCIPAL_INVESTIGATOR) |
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