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Fallopian Tube CarcinomaPhase 2NCT07495124

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

A Phase 2 study testing pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine, Carboplatin and Computed Tomography in people with Fallopian Tube Carcinoma and Ovarian Carcinoma, run by University of Washington at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine, Carboplatin and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
16 Sep 2026to 30 Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)
  • Blood glucose < 1.5 ULN (performed within 14 days of treatment initiation)

Who cannot join

  • 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
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  • 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
  • Clinically significant cardiovascular disease
  • Known severe hypersensitivity reactions to carboplatin ≥ grade 3, any history of anaphylaxis, or uncontrolled asthma
  • Patients with any contraindication to receiving recombinant human granulocyte macrophage-colony stimulating factor (rhuGM-CSF) based products
  • Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
  • Has known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis c virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
  • Has received a live vaccine or live-attenuated vaccine within 30 days of planned start of study therapy. Administration of killed vaccines is allowed
  • Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

CVI Coordinators contact

1-866-932-8588

cvitrial@uw.edu

United States1 site, 1 recruiting

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    CVI Coordinators, 866-932-8588, cvitrial@uw.edu

    John Liao, MD, PhD

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine, Carboplatin, Computed Tomography, Magnetic Resonance Imaging, Biospecimen Collection
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA VaccineBiological

    Also called IGFBP-2 plasmid-based DNA vaccine, IGFBP-2 vaccine

    Given intradermally

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

Study groups in NCT07495124
Study groupRoleWhat they receive
Treatment (carboplatin, IGFBP-2 vaccine)ExperimentalPatients 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.
Receives: Biological: pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine; Drug: Carboplatin; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 6 months

Secondary outcomes (3)

  1. Radiographic recurrence rate

    The comparison of the observed radiographic recurrence rate to the benchmark rate will be conducted by Fisher's exact test.

    Measured: At 6 months

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

    IGFBP-2 expression will be evaluated by approved laboratory assays. Positivity will be defined by elevation above normal reference range per laboratory. The predictive value of IGFBP-2 positivity toward the rate of progression free survival at 6 months will be evaluated by odds ratios computed by logistic regression, first individually and then combined as four strata. Will test the association of individual marker, the combined two marker panel, and the interaction between the two markers.

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

  3. T-cell response and IGFBP-2 accuracy of predicting clinical response

    Will evaluate whether adding T-cell response to IGFBP-2 will increase the accuracy of predicting clinical response by comparing the fitness between the two models (one with T-cell response and the other one without T-cell response). Receiver operating characteristic curve and area under the curve (AUC) will be evaluated for different panels of markers and the incremental value of adding a particular marker to AUC performance will be assessed.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start16 Sep 2026
  3. Primary completion29 Sep 2027 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07495124
Sponsor's protocol ID
RG1125984
Other IDs
NCI-2026-01282, 0021167
Status last verified
Oct 2026
First submitted
20 Mar 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine, Carboplatin and Computed Tomography in people with Fallopian Tube Carcinoma and Ovarian Carcinoma, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact CVI Coordinators (1-866-932-8588, cvitrial@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: At 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07495124.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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