Study on Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (FAROUT Trial)

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06639074

Provider View

This clinical trial is testing a new treatment using a vaccine made from a patient's own white blood cells to help the immune system target and destroy cancer cells in patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. The study compares this treatment to a placebo to see if it can better prevent or delay cancer recurrence.

Patient Parameters

Program Overview

The purpose of this study is to compare the effects of a new vaccine treatment, called folate receptor alpha dendritic cells (FRαDCs), with a placebo in patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. The vaccine is made from a patient's white blood cells, which are modified in the lab to help the immune system recognize and attack cancer cells. The study aims to find out if this vaccine can better prevent or delay the return of cancer compared to a placebo, which is an inactive substance that looks the same as the treatment but has no effect.

Description

The main goal of this study is to see if the new vaccine treatment can help patients with advanced ovarian cancer live longer without the cancer coming back. Researchers will also look at overall survival rates and compare any side effects between the vaccine and the placebo.

The study will also explore how the immune system responds to the vaccine and whether this response is linked to how long patients remain cancer-free. Researchers will examine tissue samples to understand how the cancer might evade the immune system and look at changes in the vaccine's genetic material.

Participants will be randomly assigned to one of two groups: one group will receive the vaccine, and the other will receive a placebo. Both groups may receive a tetanus vaccine before starting the treatment. The vaccine or placebo will be given under the skin on the first day of each treatment cycle. The first five cycles occur every 21 days, and the next seven cycles occur every 91 days, as long as the cancer does not progress and there are no severe side effects. Participants will also have biopsies, blood tests, and scans throughout the study.

After completing the treatment, participants will have follow-up visits every three months for up to three years, then every six months for up to eight years.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have a confirmed diagnosis of stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.
  • Have completed surgery and one course of platinum-based chemotherapy within 4 to 12 weeks before joining the study.
  • Have no BRCA1 or BRCA2 mutations.
  • Be in good overall health with an ECOG performance status of 0, 1, or 2.
  • Have a life expectancy of at least six months.
  • Meet specific blood count and organ function requirements.
  • Agree to provide blood and tissue samples for research.
  • Be willing to receive a tetanus vaccine if not done in the past year.
  • Agree to have a central line placed if needed.

Exclusion Criteria

  • Be pregnant or breastfeeding, or not willing to use contraception if of childbearing potential.
  • Have evidence of cancer at the time of joining the study.
  • Have a BRCA1 or BRCA2 mutation.
  • Have received prior radiation therapy for this cancer.
  • Have received any cancer treatment within four weeks before joining the study.
  • Have other serious health conditions that could interfere with the study.
  • Be immunocompromised or have uncontrolled infections.
  • Have had another active cancer within the past three years, with some exceptions.
  • Have a history of recent heart problems or require ongoing heart medication.
  • Be taking systemic immunosuppressive medication within two weeks before joining the study, with some exceptions for low-dose or short-term use.

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