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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06639074
Phase
PHASE2
Status
Recruiting
Apply to this trial

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
  • FIGO Stage III Ovarian Cancer 2014
  • FIGO Stage IV Ovarian Cancer 2014
  • Fallopian Tube Carcinosarcoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Ovarian Mixed Cell Adenocarcinoma
  • Primary Peritoneal Carcinosarcoma
  • Primary Peritoneal Clear Cell Adenocarcinoma
  • Primary Peritoneal Endometrioid Adenocarcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 8, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (FRalphaDCs)
    Patients may receive Td or Tdap IM prior to undergoing leukapheresis. Patients receive FRalphaDCs 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.
  • Placebo Comparator: Arm II (placebo)
    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.

Primary Outcome Measure

Recurrence-free survival [ Time Frame: Up to 8 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Nina J. Karlin, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Gerardo Colon-Otero, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Matthew S. Block, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Florida· Jacksonville, FLMayo Clinic in Rochester· Rochester, MN

Related Studies