Actively Recruiting
MC1963 Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for Patients With Advanced Stage Ovarian Cancer: A Phase II Double-Blind Randomized Clinical Trial (FAROUT)
Led by Mayo Clinic · Updated on 2025-10-02
78
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of folate receptor alpha dendritic cells (FRαDCs) 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 2:1 ratio to receive either the FRαDC 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 treatment's effects and tumor changes over time.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological confirmation of stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer with eligible histotypes
- Completion of cytoreductive surgery and one course of platinum-based chemotherapy within 4 to 12 weeks before registration
- Germline and somatic genetic testing completed with no BRCA1 or BRCA2 mutations
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Expected survival of at least 6 months
- Hemoglobin level of 8.5 g/dL or higher within 15 days prior to registration
- Absolute neutrophil count of 1000/mm3 or higher within 15 days prior to registration
- Platelet count of 75,000/mm3 or higher within 15 days prior to registration
- Lymphocytes of 0.3 x 10^9/L or higher within 15 days prior to registration
- Monocytes of 0.25 x 10^9/L or higher within 15 days prior to registration
- Total bilirubin at or below the upper limit of normal unless history of Gilbert's disease, then direct bilirubin at or below upper limit within 15 days prior to registration
- Aspartate transaminase (AST) at or below 3 times upper limit of normal within 15 days prior to registration
- Creatinine clearance of 30 mL/min or higher within 15 days prior to registration
- Provide written informed consent
- Willing to provide mandatory blood specimens and archival tissue for research
- Willing to return to study site for follow-up visits
- Willing to undergo tetanus vaccination if not done within the past year
- Willing to have a central access line placed if needed
You will not qualify if you...
- Pregnant or nursing persons
- Persons of childbearing potential or able to father a child who are unwilling to use adequate contraception
- Evidence of disease or recurrence at registration by exam, CA125 levels, or recent imaging
- Presence of BRCA1 or BRCA2 mutations
- Prior radiation therapy for this cancer
- Treatment with chemotherapy, angiogenesis inhibitors, PARP inhibitors, radiation, or immunotherapy within 4 weeks prior to registration
- Receiving other standard or investigational therapies for the primary cancer
- Severe systemic illnesses or conditions interfering with safety assessment
- Immunocompromised patients or those with HIV receiving antiretroviral therapy, except those stable without immunocompromise
- Uncontrolled illness including active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Other active malignancies within 3 years except certain skin or thyroid cancers or carcinoma in situ
- History of recent myocardial infarction or severe heart disease
- Recent or planned use of systemic immunosuppressive medications within 2 weeks before registration, with some exceptions for low-dose or inhaled steroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Short period before treatment start
Participants may receive tetanus and diphtheria vaccine prior to leukapheresis and undergo leukapheresis to prepare for vaccination or placebo administration.
1 visit for vaccination and leukapheresis
Duration - Up to approximately 2 years (12 cycles)
Participants receive either the folate receptor alpha-loaded dendritic cell vaccine or placebo intradermally on day 1 of each cycle. Cycles repeat every 21 days for cycles 1-5, then every 91 days for cycles 6-12 if there is no disease progression or unacceptable toxicity. Biopsies are performed prior to leukapheresis and optionally at the end of treatment, with blood sample collections and imaging throughout the study.
12 vaccination visits plus additional visits for biopsy, blood sample collection, and imaging as scheduled
Duration - Up to 8 years
Participants are followed every 3 months for up to 36 months, then every 3 months until disease progression, followed by every 6 months for up to 8 years in total to monitor recurrence-free and overall survival.
Regular visits every 3 months initially, then every 6 months after progression
Trial Site Locations
Total: 3 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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