Phase II Trial Comparing Folate Receptor Alpha Dendritic Cell Vaccine to Placebo for Treating Advanced Stage Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

What this Trial Is About

Researchers are evaluating the effect of folate receptor alpha dendritic cells FRDCs compared to placebo in patients with stage III or IV ovarian, fallopian tube, or primary peritoneal cancer. This phase II trial aims to boost the immune system to recognize and destroy tumor cells by targeting a protein called folate receptor alpha found on ovarian tumor cells. The study also investigates recurrence-free survival, overall survival, side effects, and immune responses in these patients. Participants are randomly assigned in a 21 ratio to receive either the FRDC vaccine or a placebo. Before treatment, patients may receive tetanus and diphtheria vaccines and undergo leukapheresis to collect white blood cells used in making the vaccine. Treatments are given intradermally on day 1 of each cycle, with cycles every 21 days for the first five cycles and every 91 days for cycles six to twelve, provided there is no disease progression or unacceptable side effects. Patients also undergo biopsies, blood sample collection, and imaging scans such as CT or MRI throughout the study. After completing the treatment phase, participants are followed up every three months for up to 36 months, then every three months until disease progression, and finally every six months for up to eight years. Researchers monitor recurrence-free survival as the primary outcome and assess overall survival and adverse events. The study includes detailed immune system assessments and tissue comparisons to understand the treatments effects and tumor changes over time.

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