Recruiting

Phase 2

FRαDCsFolate 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

Sponsor:

Mayo Clinic

Code:

NCT06639074

Conditions

Advanced Fallopian Tube Carcinoma

Advanced Fallopian Tube High Grade Serous Adenocarcinoma

Advanced Ovarian Carcinoma

Advanced Ovarian Carcinosarcoma

Advanced Ovarian Clear Cell Adenocarcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy

Biospecimen Collection

Computed Tomography

Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed

Leukapheresis

Study Details

Brief summary:

This phase II trial compares the effect of folate receptor alpha dendritic cells (FRαDCs) to placebo in treating patients with stage III or IV ovarian, fallopian tube or primary peritoneal cancer. FRαDCs, a dendritic cell vaccine, is made from a person's white blood cells. The white blood cells are treated in the laboratory to make dendritic cells (a type of immune cell) mixed with folate receptor alpha (FRalpha), a protein found in high levels on ovarian tumor cells. FRαDCs work by boosting the immune system to recognize and destroy the tumor cells by targeting the FRalpha protein on the tumor cell. Placebo is an inactive substance that looks the same as, and is given the same way as, the active drug or treatment being tested. The effects of the active drug are compared to the effects of the placebo. Giving FRαDCs may work better in preventing or delaying recurrence compared to placebo in patients with stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.

Conditions

Advanced Fallopian Tube Carcinoma

Advanced Fallopian Tube High Grade Serous Adenocarcinoma

Advanced Ovarian Carcinoma

Advanced Ovarian Carcinosarcoma

Advanced Ovarian Clear Cell Adenocarcinoma

Study ID

NCT06639074

Start date

Nov 8, 2024

Status verified date

Sep, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I (FRalphaDCs)

Patients may receive Td or Tdap IM prior to undergoing leukapheresis. Patients receive FRalphaDCs ID on day 1 of each cycle. Cycles repeat every 21 days for cycles 1-5 and then repeat every 91 days for cycles 6-12 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo biopsy prior to apheresis and optionally at end of treatment, and blood sample collection, CT and/or MRI throughout the study.

placebo comparator: Arm II (placebo)

Patients may receive Td or Tdap IM prior to undergoing leukapheresis. Patients receive placebo ID on day 1 of each cycle. Cycles repeat every 21 days for cycles 1-5 and then repeat every 91 days for cycles 6-12 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo biopsy prior to apheresis and optionally at end of treatment, and blood sample collection, CT and/or MRI throughout the study.

Interventions

Biopsy

Undergo biopsy

Biospecimen Collection

Undergo blood sample collection

Computed Tomography

Undergo CT

Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed

Given IM

Leukapheresis

Undergo leukapheresis

Magnetic Resonance Imaging

Undergo MRI

Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine

Given ID

Placebo Administration

Given ID

Tetanus and Diphtheria Toxoids Adsorbed

Given IM

Primary outcome measure

Recurrence-free survival [ Time Frame: Up to 8 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Nina J. Karlin, MD

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Gerardo Colon-Otero, MD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Matthew S. Block, MD, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-10-02.