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

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 tumo

Trial Details

NCT ID
NCT06639074
Phase
PHASE2
Sponsor
Mayo Clinic
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • Biopsy
  • Biospecimen Collection
  • Computed Tomography
  • Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed
  • Leukapheresis
  • Magnetic Resonance Imaging
Locations (sample)
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Rochester, Minnesota, United States|44.02163,-92.4699

Key Eligibility Criteria

  • Age ≥ 18 years
  • Histological confirmation of Federation of Gynecology and Obstetrics (FIGO) stage III or stage IV epithelial ovarian, fallopian tube, or primary pe…
  • 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…

For full eligibility, visit ClinicalTrials.gov.

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