RecruitingPhase 2NCT06639074

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

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)


Sponsor

Mayo Clinic

Enrollment

78 participants

Start Date

Nov 8, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (FAROUT Trial) tests an experimental immunotherapy vaccine called FRαDCs — made from a patient's own immune cells — for women with advanced stage III or IV ovarian, fallopian tube, or primary peritoneal cancer. The vaccine is given after standard surgery and chemotherapy to try to prevent the cancer from coming back. **You may be eligible if...** - You are 18 or older with confirmed stage III or IV ovarian, fallopian tube, or primary peritoneal cancer - Your cancer is high-grade serous, endometrioid, or clear cell type - You have completed surgery (including hysterectomy and removal of both ovaries) and one course of platinum-based chemotherapy (5–9 cycles) within the past 4–12 weeks - You do not carry BRCA1 or BRCA2 gene mutations - Your blood counts and immune cell levels meet required thresholds **You may NOT be eligible if...** - You carry a BRCA1 or BRCA2 mutation - You have received more than one course of chemotherapy or treatment for a cancer recurrence - You have a poor performance status or serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT

BIOLOGICALDiphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed

Given IM

PROCEDURELeukapheresis

Undergo leukapheresis

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALMulti-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine

Given ID

DRUGPlacebo Administration

Given ID

BIOLOGICALTetanus and Diphtheria Toxoids Adsorbed

Given IM


Locations(3)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT06639074


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