ClinicalTrials.gg
RecruitingNCT07495124Updated Nov 2, 2026

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

A Phase 2 interventional study of pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine and Carboplatin in Fallopian Tube Carcinoma, Ovarian Carcinoma and Primary Peritoneal Carcinoma, sponsored by University of Washington. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by University of Washington · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 589 studies in Fallopian Tube Neoplasms with a site in United States — 63 open to participants now, 130 under way, 24 of them phase 3. Fallopian Tube Neoplasms · United States.

Planned enrollment
334th of 513
26 · median 40
Started
2026
with 6 others
Phase 2
211 of 589
20 open now
Primary completion
2027-09
later than 80 of 129 live
Registered
583rd of 589
by date
Lead sponsor
8 of 589
University of Washington

Among the 589 studies in Fallopian Tube Neoplasms with a site in United States, this one is the 334th largest by planned enrollment of the 513 interventional ones that give a count, is one of 7 that started in 2026, is one of 211 in phase 2, reaches primary completion later than 80 of the 129 other live ones, and was the 583rd registered.

Fallopian Tube Neoplasms

835 studies on the registry are indexed under Fallopian Tube Neoplasms; 131 are open to participants now.

Browse Fallopian Tube Neoplasms studies →

Open to participants now

63 of the 589 studies in Fallopian Tube Neoplasms with a site in United States are open now. Recruiting first, the newest first:

57 more — sign in →

All 63 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 105 Fallopian Tube Neoplasms studies recruiting now, 87 (83%) set no upper age limit and 10 (10%) stop at 75 or younger; 6 take children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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02

Study 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.

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.

03

Conditions studied

  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 therapy
  • CA-125 increased to more than twice the or two times the nadir value after most recent second or later line of treatment
  • Have no based on (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 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
  • Have estimated of at least 3 months
  • Be willing and able to provide written /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 (ECOG) performance scale
  • White blood cell (WBC) ≥ 3000/mm\^3 (performed within 14 days of treatment initiation)
  • (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 > 60 mL/min (performed within 14 days of treatment initiation)
  • Total ≤ 2.5 mg/dl (performed within 14 days of treatment initiation)
  • (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)

Exclusion criteria

Exclusion Criteria:

  • Is currently participating and receiving study therapy or has participated in a study of an 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 therapy (if dosing exceeding 10 mg daily of prednisone equivalent) or any other form of 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 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) and/or carcinomatous meningitis. Patients with previously treated 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 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
  • cardiovascular disease
  • Known severe reactions to carboplatin ≥ grade 3, any history of anaphylaxis, or uncontrolled asthma
  • Patients with any to receiving recombinant human granulocyte macrophage-colony stimulating factor (rhuGM-CSF) based products
  • Has a known history of (HIV) (HIV 1/2 antibodies)
  • Has known active (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or (e.g., hepatitis c virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
  • Has received a 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
Terms in these criteria, in plain language(27)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (estimated)

Study 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.

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

Interventions

  • Given intradermally

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

  • 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

  • ProcedureComputed Tomography

    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

  • ProcedureMagnetic Resonance Imaging

    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

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

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

06

What researchers measure

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.

    Time frame: At 6 months

Secondary outcomes

  1. Radiographic recurrence rate

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

    Time frame: 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.

    Time frame: 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.

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

07

Study locations

1 of 1 sites recruiting
  • Fred Hutch/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
    Recruiting
    • CVI Coordinators · Contactcvitrial@uw.edu · 866-932-8588
    • John Liao, MD, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Sep 2027, 12 months after the start.

Of 98 non-industry phase 2 interventional studies under Fallopian Tube Neoplasms, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 91. This study's planned 12 months is below that.

Counting every sponsor, half of 125 studies reached it within 56 months; a quarter within 42 and three quarters within 90.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2026
First posted
Mar 27, 2026
StartActual
Sep 16, 2026
Primary completionEst.
Sep 29, 2027
CompletionEst.
Sep 30, 2028
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07495124
Collaborators
The Wayne D. Kuni and Joan E. Kuni Foundation
Responsible party
Sponsor
First posted
Mar 27, 2026
Start date
Sep 16, 2026
Primary completion
Sep 29, 2027 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Nov 2, 2026

Study contacts

CVI Coordinators
Contact
cvitrial@uw.edu
1-866-932-8588
John Liao, MD, PhD
principal investigator · Fred Hutch/University of Washington Cancer Consortium

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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