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

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.

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

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

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Matthew S. Block, MD, PhD · Mayo Clinic in Rochester

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-08

Primary Completion

2027-12-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations