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NCT06639074 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Advanced Ovarian Carcinoma and Advanced Fallopian Tube Carcinoma, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 3
- Study locations
NCT06639074: Recruiting Phase 2 study of Advanced Ovarian Carcinoma and Advanced Fallopian Tube Carcinoma, sponsored by Mayo Clinic.
NCT06639074 is a Phase 2 study of Advanced Ovarian Carcinoma and Advanced Fallopian Tube Carcinoma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 78 participants, below the 122-participant average among 10 other Advanced Ovarian Carcinoma trials with a reported enrollment target (36% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06639074, a Phase 2 study of Advanced Ovarian Carcinoma and Advanced Fallopian Tube Carcinoma, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- PROCEDURE Leukapheresis
- BIOLOGICAL Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed
Study Locations (3)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2024-11-08 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT06639074 shows while recruiting
NCT06639074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 122-participant average among 10 other Advanced Ovarian Carcinoma trials with a reported enrollment target (36% lower).
The record links to 10 conditions, with Advanced Ovarian Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06639074 reports a single indexed study location in Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06639074 about?
NCT06639074 is a clinical study titled "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 ...
What is the current status of trial NCT06639074?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2024-11-08. Estimated completion is 2027-12-31.
What conditions does trial NCT06639074 study?
This clinical trial studies the following conditions: Advanced Ovarian Carcinoma, Advanced Fallopian Tube Carcinoma, Advanced Primary Peritoneal Carcinoma, Fallopian Tube Carcinosarcoma, Advanced Ovarian Clear Cell Adenocarcinoma.
What interventions are being tested in trial NCT06639074?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Leukapheresis (PROCEDURE), Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed (BIOLOGICAL).
Who is sponsoring clinical trial NCT06639074?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06639074 being conducted?
This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06639074's enrollment target sits among peer trials
78 5th of 10 higher than 6 of 10 other Advanced Ovarian Carcinoma trials
participants (enrollment target), bucketed by value
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