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

NCT06639074 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: MC1963NCI-2024-0846624-000088
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

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; Advanced Ovarian Endometrioid Adenocarcinoma; Advanced Ovarian High Grade Serous Adenocarcinoma; Advanced Primary Peritoneal Carcinoma; Advanced Primary Peritoneal High Grade Serous Adenocarcinoma; Fallopian Tube Carcinosarcoma; Fallopian Tube Clear Cell Adenocarcinoma; Fallopian Tube Endometrioid Adenocarcinoma; FIGO Stage III Ovarian Cancer 2014; FIGO Stage IV Ovarian Cancer 2014; Ovarian Mixed Cell Adenocarcinoma; Primary Peritoneal Carcinosarcoma; Primary Peritoneal Clear Cell Adenocarcinoma; Primary Peritoneal Endometrioid Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival

  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.

  Up to 8 years

Secondary Outcomes (2)

• Overall survival (OS)

  Up to 8 years

• Incidence of adverse events (AEs)

  Up to 30 days after last dose of study treatment

Study Arms (2)

Arm I (FRalphaDCs)

EXPERIMENTAL

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.

Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed; Procedure: Leukapheresis; Procedure: Magnetic Resonance Imaging; Biological: Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine; Biological: Tetanus and Diphtheria Toxoids Adsorbed

Arm II (placebo)

PLACEBO COMPARATOR

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.

Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed; Procedure: Leukapheresis; Procedure: Magnetic Resonance Imaging; Drug: Placebo Administration; Biological: Tetanus and Diphtheria Toxoids Adsorbed

Interventions

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

Arm I (FRalphaDCs); Arm II (placebo)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (FRalphaDCs); Arm II (placebo)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Arm I (FRalphaDCs); Arm II (placebo)

Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed BIOLOGICAL

Given IM

Also known as: Adacel, Daptacel, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Diphtheria Toxoid Tetanus Toxoid Acellular Pertussis Vaccine Adsorbed, Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine, DTaP, Infanrix, Tripedia

Arm I (FRalphaDCs); Arm II (placebo)

Leukapheresis PROCEDURE

Undergo leukapheresis

Also known as: Leukocyte Adsorptive Apheresis, Leukocytopheresis, Therapeutic Leukopheresis, White Blood Cell Reduction Apheresis

Arm I (FRalphaDCs); Arm II (placebo)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Arm I (FRalphaDCs); Arm II (placebo)

Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine BIOLOGICAL

Given ID

Also known as: FRaDC Vaccine, FRalphaDC Vaccine

Arm I (FRalphaDCs)

Placebo Administration DRUG

Given ID

Arm II (placebo)

Tetanus and Diphtheria Toxoids Adsorbed BIOLOGICAL

Given IM

Also known as: DECAVAC, Td, Tetanus and Diphtheria Toxoids Adsorbed for Adult Use

Arm I (FRalphaDCs); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Biopsy; Specimen Handling; Diphtheria Toxoid; adacel; Diphtheria-Tetanus-acellular Pertussis Vaccines; Tetanus Toxoid; Leukapheresis; Magnetic Resonance Spectroscopy; Diphtheria-Tetanus Vaccine

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Toxoids; Vaccines; Biological Products; Complex Mixtures; Pertussis Vaccine; Bacterial Vaccines; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit; Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Matthew S. Block, MD, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patient, provider and principal investigator are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are allocated randomly to vaccine versus placebo in a 2:1 fashion.

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (3)