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

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Dec 31, 2027 → Apr 23, 2029
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Record History

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  1. Primary and study completion pushed from Dec 31, 2027 to Apr 23, 2029 Show 4 more changesShow less
    • Start date: Nov 8, 2024 to Nov 12, 2024
    • Interventions: Biopsy (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Diphtheria Toxoid/Tetanus Toxoid/Acellular… to Biopsy (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Diphtheria Toxoid/Tetanus Toxoid/Acellular…
    • Eligibility criteria expanded, about 53 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. 2 versions Re-verified since Sep 3, 2025, no change to tracked fieldsv5-v6
  3. Study description expanded, about 6 words
    • Site details revised at 3 of 3 sites
    v4
  4. Site details revised at 3 of 3 sitesv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 12, 2024 to Nov 8, 2024
    • Site details revised at 3 of 3 sites
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Mayo Clinic
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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.
Trial Details
NCT Number NCT06639074
Lead Sponsor Mayo Clinic
Conditions
(from sponsor)		 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 +10 more
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov