New vaccine aims to outsmart ovarian cancer recurrence
NCT ID NCT06639074
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests whether a custom-made vaccine (FRαDCs) can help prevent or delay cancer from coming back in people with stage III or IV ovarian, fallopian tube, or primary peritoneal cancer. The vaccine is made from a patient's own white blood cells and trained to target a protein (FRα) found on many ovarian tumor cells. Half of the 78 participants will receive the vaccine, and half will receive a placebo, to see if the vaccine improves recurrence-free survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dendritic cell vaccine targeting folate receptor alpha (FRαDCs)
- What this could lead to
- If it works, this vaccine could help delay or prevent cancer recurrence in people with advanced ovarian cancer, offering a new way to keep the disease under control.
- What could go wrong
- This is a phase II trial with only 78 participants, so results are still early. The vaccine may not work better than placebo, and side effects from immune activation 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 78 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Dec 2027
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: * Age ≥ 18 years * Histological confirmation of Federation of Gynecology and Obstetrics (FIGO) stage III or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. NOTE: Histologic confirmation of the primary tumor is required. Eligible histotypes include high grade serous; endometrioid; and clear cell carcinoma, as these histotypes have high expression of FRα (Kalli, Oberg, Keeney, \& et al., 2008). Mixed carcinomas, including carcinosarcomas, with ≥ 50% of the tumor comprised of high grade serous; and/or endometrioid; and/or clear cell carcinoma are eligible * Completion of cytoreductive surgery and one (and only one) course of platinum-based chemotherapy (5-9 cycles) ≥ 4 but ≤ 12 weeks prior to registration * NOTE: Cytoreductive surgery may have been prior to or after one or more cycles of chemotherapy and must include hysterectomy and bilateral salpingo-oophorectomy (if the uterus and/or ovaries were not previously removed) * NOTE: Patients may have had more than one chemotherapy regimen (examples: paclitaxel/carboplatin switched to docetaxel/carboplatin due to allergy; or weekly treatment switched to every 3-weekly treatment due to intolerance), but may not have received a separate course of treatment for recurrent OC * NOTE: Patients may receive both neoadjuvant and adjuvant chemotherapy provided both regimens are platinum-based and total nine (9) or fewer chemotherapy cycles * Germline and somatic genetic testing have been completed * NOTE: No pathogenic mutations of BRCA1/BRCA2 are allowed * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Expected survival ≥ 6 months * Hemoglobin ≥ 8.5 g/dL (≤ 15 days prior to registration) * Absolute neutrophil count (ANC) ≥ 1000/mm\^3 (≤ 15 days prior to registration) * Platelet count ≥ 75,000/mm\^3 (≤ 15 days prior to registration) * Lymphocytes ≥ 0.3 x 10\^9/L (≤ 15 days prior to registration) * Monocytes ≥ 0.25 x 10\^9/L (≤ 15 days prior to registration) * Total bilirubin ≤ upper limit of normal (ULN), unless patient has a documented history of Gilbert's disease, then direct bilirubin ≤ ULN (≤ 15 days prior to registration) * Aspartate transaminase (AST) ≤ 3 x ULN (≤ 15 days prior to registration) * Creatinine clearance ≥ 30 mL/min per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (≤ 15 days prior to registration) * Provide written informed consent * Willing to provide mandatory blood specimens for correlative research * Willing to provide archival tissue specimen for correlative research * Willing to return a participating institution for follow-up (during the active monitoring phase of the study) * Willing to undergo a tetanus vaccination (if not performed ≤ 365 days prior to registration) * Willing to have a central access line placed, if needed (as determined during venous access assessment) Exclusion Criteria: * Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown * Pregnant persons * Nursing persons * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception * Evidence of disease at the time of registration, including clinical concern for disease recurrence based on each of the following: * Evidence of disease by history and physical exam * CA125 outside institutional normal limits * CT (and or MRI) of the chest/abdomen/pelvis demonstrating radiological evidence of disease performed after completion of chemotherapy ≤ 28 days be-fore entering study * Germline or somatic BRCA1 or BRCA2 mutation, as determined by Clinical Laboratory Improvement Act (CLIA)-approved tests * Prior radiation therapy for this cancer * Treatment with chemotherapy, angiogenesis inhibitor therapy, poly (ADP-ribose) polymerase (PARP) inhibitor therapy, radiation therapy, or other immunotherapy ≤ 4 weeks prior to registration * Receiving any other standard therapy (angiogenesis inhibitor, PARP inhibitor) or investigational agent, which would be considered as a treatment for the primary neoplasm. These agents have been shown to be active in later line therapy and can be used at that time for patients who relapse after treatment on this trial * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial * Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * EXCEPTIONS: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For patients with evidence of hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Other active malignancy ≤ 3 years prior to registration * EXCEPTIONS: Patients with non-melanotic skin cancer, papillary thyroid cancer not requiring therapy or carcinoma-in-situ are eligible for this trial. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. (Contact site principal investigator \[PI\] if questions.) * History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * NOTE: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * Treatment with systemic immunosuppressive medication (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[TNF\]-alpha agents) ≤ 2 weeks prior to registration, or anticipation of need for systemic immunosuppressive medication during the course of the study * NOTE: Patients who have received acute, low-dose systemic steroids (≤ 10 mg/day oral prednisone or equivalent) prior to registration or a one-time pulse dose of systemic immunosuppressant medication (e.g., ≤ 48 hours of corticosteroids for a contrast allergy) are eligible for the study * NOTE: The use of inhaled corticosteroids for chronic obstructive pulmonary disease or asthma, mineralocorticoids (e.g., fludrocortisone), or low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is 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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites. 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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Mayo Clinic in Arizona
RECRUITINGScottsdale, Arizona, 85259, United States
Contact Email: •••••@•••••
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Mayo Clinic in Florida
RECRUITINGJacksonville, Florida, 32224-9980, United States
Contact Email: •••••@•••••
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
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