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Clinical trialNCT06639074RecruitingPhase 2Interventional

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

SponsorMayo ClinicEnrollment78Advanced Fallopian Tube CarcinomaAdvanced Fallopian Tube High Grade Serous AdenocarcinomaAdvanced Ovarian CarcinomaAdvanced Ovarian CarcinosarcomaAdvanced Ovarian Clear Cell AdenocarcinomaAdvanced Ovarian Endometrioid Adenocarcinoma+12 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Mayo Clinic in Arizona

    Scottsdale, Arizona, United States

    Nina J. Karlin, MD
    Recruiting
  • Mayo Clinic in Florida

    Jacksonville, Florida, United States

    Gerardo Colon-Otero, MD
    Recruiting
  • Mayo Clinic in Rochester

    Rochester, Minnesota, United States

    Matthew S. Block, MD, PhD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Diphtheria toxoid vaccine, inactivatedMulti-epitope Folate Receptor Alpha-loaded Dendritic Cell VaccinePlacebo AdministrationTetanus and Diphtheria Toxoids Adsorbed
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
8 Nov 2024
Primary completion
31 Dec 2027
Completion
31 Dec 2027
Last update posted
2 Oct 2025
Registered enrollment
78
Registry id
NCT06639074

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.