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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

ConditionsAdvanced Fallopian Tube CarcinomaAdvanced Fallopian Tube High Grade Serous AdenocarcinomaAdvanced Ovarian CarcinomaAdvanced Ovarian CarcinosarcomaAdvanced Ovarian Clear Cell AdenocarcinomaAdvanced Ovarian Endometrioid AdenocarcinomaAdvanced Ovarian High Grade Serous AdenocarcinomaAdvanced Primary Peritoneal CarcinomaAdvanced Primary Peritoneal High Grade Serous AdenocarcinomaFallopian Tube CarcinosarcomaFallopian Tube Clear Cell AdenocarcinomaFallopian Tube Endometrioid AdenocarcinomaFIGO Stage III Ovarian Cancer 2014FIGO Stage IV Ovarian Cancer 2014Ovarian Mixed Cell AdenocarcinomaPrimary Peritoneal CarcinosarcomaPrimary Peritoneal Clear Cell AdenocarcinomaPrimary Peritoneal Endometrioid Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Undergo biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed

    Biological/Vaccine

    Given IM

  • Leukapheresis

    Procedure/Surgery

    Undergo leukapheresis

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

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

    Biological/Vaccine

    Given ID

  • Placebo Administration

    Drug

    Given ID

  • Tetanus and Diphtheria Toxoids Adsorbed

    Biological/Vaccine

    Given IM

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Arm I (FRalphaDCs)Experimental treatment 8 interventions
Group B: Arm II (placebo)Placebo comparator 8 interventions

Trial outcomes

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.

Time frame
Up to 8 years

Secondary outcomes

1

Overall survival (OS)

Overall survival (OS) will be compared in advanced OC patients vaccinated with FRαDCs versus placebo. OS is defined as the time from study entry to death from any cause.

Time frame
Up to 8 years
2

Incidence of adverse events (AEs)

The maximum grade for each type of AE will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The frequency and percentage of grade 3 and greater AEs will be compared between the 2 arms.

Time frame
Up to 30 days after last dose of study treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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