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
Public ClinicalTrials.gov record NCT06639074. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
MC1963 Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for Patients With Advanced Stage Ovarian Cancer: A Phase II Double-Blind Randomized Clinical Trial (FAROUT)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06639074
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 78 participants
Conditions and interventions
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
Interventions
- Biopsy Procedure
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed Biological
- Leukapheresis Procedure
- Magnetic Resonance Imaging Procedure
- Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine Biological
- Placebo Administration Drug
- Tetanus and Diphtheria Toxoids Adsorbed Biological
Procedure · Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 7, 2024
- Primary completion
- Dec 30, 2027
- Completion
- Dec 30, 2027
- Last update posted
- Oct 1, 2025
2024 – 2027
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | Recruiting |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | Recruiting |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06639074, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06639074 live on ClinicalTrials.gov.