NCT06639074 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 8, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions

Advanced Fallopian Tube CarcinomaAdvanced Fallopian Tube High Grade Serous AdenocarcinomaAdvanced Ovarian CarcinomaAdvanced Ovarian CarcinosarcomaAdvanced Ovarian Clear Cell AdenocarcinomaAdvanced Ovarian Endometrioid AdenocarcinomaAdvanced Ovarian High Grade Serous AdenocarcinomaAdvanced Primary Peritoneal CarcinomaAdvanced Primary Peritoneal High Grade Serous AdenocarcinomaFallopian Tube CarcinosarcomaFallopian Tube Clear Cell AdenocarcinomaFallopian Tube Endometrioid AdenocarcinomaFIGO Stage III Ovarian Cancer 2014FIGO Stage IV Ovarian Cancer 2014Ovarian Mixed Cell AdenocarcinomaPrimary Peritoneal CarcinosarcomaPrimary Peritoneal Clear Cell AdenocarcinomaPrimary 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

Trial Locations (3)

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

85259

RECRUITING

Mayo Clinic in Arizona, Scottsdale

32224-9980

RECRUITING

Mayo Clinic in Florida, Jacksonville