Trials / Recruiting

RecruitingNCT06639074

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)

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 78 (estimated)

Sponsor: Mayo Clinic · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Compare recurrence-free survival (RFS) in advanced ovarian carcinoma (OC) patients vaccinated with multi-epitope folate receptor alpha-loaded dendritic cell vaccine (FRαDCs) (active vaccine) versus placebo. SECONDARY OBJECTIVES: I. Compare overall survival (OS) in advanced OC patients vaccinated with FRαDCs versus placebo. II. Compare the adverse event (AE) profile of FRαDCs with that of placebo. CORRELATIVE RESEARCH OBJECTIVES: I. Assess association of pre-existing immune microenvironment with RFS. II. Characterize the T cell and antibody responses to FRα and assess the association between the emergence of immunity and RFS. III. Assess for epitope spreading and evaluate the association between epitope spreading and RFS. IV. Compare archival tissue from surgery with post-recurrence biopsy tissue in those patients who develop recurrence to assess for common immune evasion mechanisms. V. Evaluate differences in ribonucleic acid (RNA) expression of FRαDCs and its association with RFS. OUTLINE: Patients are randomized to 1 of 2 arms. Randomization is 2:1, vaccine to placebo. ARM I: Patients may receive tetanus and diphtheria vaccine (Td) or tetanus-diphtheria-accellular pertussis vaccine (Tdap) intramuscularly (IM) prior to undergoing leukapheresis. Patients receive FRalphaDCs intradermally (ID) on day 1 of each cycle. Cycles repeat every 21 days for cycles 1-5 and then repeat every 91 days for cycles 6-12 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo biopsy prior to apheresis and optionally at end of treatment, and blood sample collection, computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study.f ARM II: Patients may receive Td or Tdap IM prior to undergoing leukapheresis. Patients receive placebo ID on day 1 of each cycle. Cycles repeat every 21 days for cycles 1-5 and then repeat every 91 days for cycles 6-12 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo biopsy prior to apheresis and optionally at end of treatment, and blood sample collection, CT and/or MRI throughout the study. After completion of study treatment, patients are followed up every 3 months for up to month 36 then every 3 months until progression followed by every 6 months for up to year 8.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo CT
BIOLOGICAL	Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed	Given IM
PROCEDURE	Leukapheresis	Undergo leukapheresis
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
BIOLOGICAL	Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine	Given ID
DRUG	Placebo Administration	Given ID
BIOLOGICAL	Tetanus and Diphtheria Toxoids Adsorbed	Given IM

Timeline

Start date: 2024-11-08
Primary completion: 2027-12-31
Completion: 2027-12-31
First posted: 2024-10-15
Last updated: 2025-10-02

Locations

3 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06639074. Inclusion in this directory is not an endorsement.