New vaccine aims to halt ovarian cancer recurrence detected in blood
NCT ID NCT07495124
First seen Jun 25, 2026 · Last updated Sep 21, 2026 · Updated 6 times
Summary
This phase II trial tests whether an IGFBP-2 vaccine, given after one dose of carboplatin, can stop ovarian cancer from growing in patients whose recurrence is detected only through a blood test. The vaccine helps the immune system target cancer cells, while carboplatin primes the immune response. The study includes 26 participants with ovarian, fallopian tube, or primary peritoneal cancer who have completed platinum-based chemotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IGFBP-2 vaccine (DNA vaccine) plus carboplatin
- What this could lead to
- If it works, this could offer a new way to delay or prevent ovarian cancer from growing after it is first detected in the blood, potentially extending time without visible disease.
- What could go wrong
- This is a small, early-phase trial with only 26 participants, so results may not apply to everyone. The vaccine may not trigger a strong enough immune response, and side effects from carboplatin are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fred Hutch/University of Washington Cancer Consortium
RECRUITINGSeattle, Washington, 98109, United States
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