IGFBP-2 Vaccine and Carboplatin for Ovarian Cancer Recurrence
This study is testing if a vaccine called pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine, given after one dose of carboplatin, can help stop ovarian, fallopian tube, or primary peritoneal cancer from growing or spreading. This is for women whose cancer recurrence is only found through blood tests (serologic detection) after previous platinum-based chemotherapy. The pUMVC3-hIGFBP-2 vaccine may help your body's immune system fight cancer cells. Carboplatin is a chemotherapy drug that might also help the immune system. The study aims to see how long patients live without their cancer progressing (getting worse) at 6 months. We plan to enroll 26 participants. The current status of this study is unclear.
- Study design
- This is an interventional study for women with ovarian, fallopian tube, or primary peritoneal cancer who have received platinum-based chemotherapy. Participants will receive carboplatin and the pUMVC3-hIGFBP-2 vaccine.
- What's involved
- You will receive carboplatin once, then the vaccine every 4 weeks for up to 3 cycles. You may be eligible for additional vaccines later. You will also have blood tests, CT scans, and/or MRI scans throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you will be followed up at 4 weeks, then every 4 weeks for 1 year, and then every 6 months for 2 years.
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NCT07495124
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of WashingtonInvestigator-initiated
~26 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA VaccineCarboplatinComputed TomographyMagnetic Resonance ImagingBiospecimen Collection
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival
Measured over At 6 months
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- John Liao, MD, PhD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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)
Blood glucose \< 1.5 ULN (performed within 14 days of treatment initiation)
Exclusion
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
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
What this trial measures
- Progression free survivalAt 6 months
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.