FAROUT Trial: Folate Receptor Alpha Dendritic Cells for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This study, called the FAROUT Trial, is testing a treatment called Folate Receptor Alpha Dendritic Cells (FRαDCs) against a placebo for women with stage III or IV ovarian, fallopian tube, or primary peritoneal cancer. FRαDCs are made from your own white blood cells, which are specially treated to help your immune system find and destroy cancer cells by targeting a protein called folate receptor alpha (FRalpha) found on these tumors. The study aims to see if FRαDCs can help prevent the cancer from coming back (recurrence-free survival) compared to the placebo, which is an inactive substance. You may be eligible if you are at least 18 years old and have a confirmed diagnosis of one of these cancers. The study plans to enroll 78 participants.
- Study design
- This is an interventional study where participants are randomly assigned to receive either FRαDCs or a placebo, with 78 participants planned.
- What's involved
- You would undergo a biopsy, blood sample collection, CT scans, leukapheresis (a procedure to collect white blood cells), and receive either a tetanus/diphtheria vaccine or a tetanus-diphtheria-acellular pertussis vaccine, followed by intradermal injections of FRαDCs or placebo.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your recurrence-free survival will be measured for up to 8 years after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06639074
Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for the Treatment of Patients With Stage III or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, FAROUT Trial
Recruiting
PHASE2Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~78 participants
Updated 2025-10-02 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionComputed TomographyDiphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine AdsorbedLeukapheresisMagnetic Resonance Imaging
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence-free survival
Measured over Up to 8 years
Conditions
Where it's being run
3 sites across 3 statesArizona1
Florida1
Minnesota1
Study leadership
- Matthew S. Block, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Recurrence-free survivalUp to 8 years
Recurrence-free survival (RFS) will be compared inadvanced OC patients vaccinated with FRαDCs (active vaccine) versus placebo. RFS is defined as the time from study entry to either disease recurrence or death from any cause.