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

NCT07495124 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: RG1125984NCI-2026-012820021167
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Peritoneal Carcinoma; Fallopian Tube Carcinoma; Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Will compare the progression free survival based on radiographic imaging at 6 months to historical control rates for this population of patients treated by letrozole or tamoxifen. The comparison of the observed rate of progression free survival at 6 months to the benchmark rate will be conducted by Fisher's exact test. The Kaplan-Meier survival curve will be plotted and the median progression free survival will be compared to the historical progression free survival with Greenwood confidence interval.

  At 6 months

Secondary Outcomes (3)

• Radiographic recurrence rate

  At 6 months

• Predictive value of insulin-like growth factor-binding protein 2 (IGFBP-2) positivity toward the rate of progression free survival

  At baseline, 4 weeks post-last vaccine, and 6 months post-first vaccine

• T-cell response and IGFBP-2 accuracy of predicting clinical response

  At baseline, 4 weeks post-last vaccine, and 6 months post-first vaccine

Study Arms (1)

Treatment (carboplatin, IGFBP-2 vaccine)

EXPERIMENTAL

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.

Biological: pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine; Drug: Carboplatin; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection

Interventions

pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine BIOLOGICAL

Given intradermally

Also known as: IGFBP-2 plasmid-based DNA vaccine, IGFBP-2 vaccine

Treatment (carboplatin, IGFBP-2 vaccine)

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Treatment (carboplatin, IGFBP-2 vaccine)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Treatment (carboplatin, IGFBP-2 vaccine)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (carboplatin, IGFBP-2 vaccine)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (carboplatin, IGFBP-2 vaccine)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer who have received systemic chemotherapy including platinum-based chemotherapy
• Have a cancer antigen 125 (CA-125) that normalized after first-line therapy
• CA-125 increased to more than twice the upper limit of normal or two times the nadir value after most recent second or later line of treatment
• Have no measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Ascites and pleural effusions are not measurable disease, if asymptomatic
• All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of the study (end of one year follow up). Note: Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or postmenopausal
• Have estimated life expectancy of at least 3 months
• Be willing and able to provide written informed consent/assent for the trial
• Be ≥ 18 years of age on day of signing informed consent
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
• White blood cell (WBC) ≥ 3000/mm\^3 (performed within 14 days of treatment initiation)
• Hemoglobin (Hgb) ≥ 10 g/dl (performed within 14 days of treatment initiation)
• Hematocrit (Hct) ≥ 28% (performed within 14 days of treatment initiation)
• Serum creatinine ≤ 2.0 mg/dl or creatinine clearance \> 60 mL/min (performed within 14 days of treatment initiation)
• Total bilirubin ≤ 2.5 mg/dl (performed within 14 days of treatment initiation)
• Aspartate aminotransferase (AST) ≤ 3 times upper limit of normal (ULN) (performed within 14 days of treatment initiation)

You may not qualify if:

• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment (i.e., day 1)
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (if dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
• Short-term administration of systemic steroids (i.e., for allergic reactions or the management of immune-related adverse events \[irAEs\]) is allowed
• Has symptomatic ascites or pleural effusions
• History of borderline or low malignant potential ovarian cancer
• Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
• Has had prior chemotherapy, biologic therapy, targeted small molecule therapy, hormonal therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent
• Note: Patients with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study
• Note: If a patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
• Has an active infection requiring systemic therapy
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
• Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment

Sponsors & Collaborators

• University of Washington: lead
• The Wayne D. Kuni and Joan E. Kuni Foundation: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Carboplatin; Magnetic Resonance Spectroscopy; Specimen Handling

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• John Liao, MD, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CVI Coordinators

CONTACT

1-866-932-8588; cvitrial@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): September 29, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)