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Cancer Vaccine

Folate Receptor Alpha Vaccine for Ovarian Cancer

Phase 2
Waitlist Available
Led By Matthew S. Block, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Age ≥ 18 years
Must not have
Co-morbid systemic illnesses or severe concurrent diseases
Prior radiation therapy for this cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years

Summary

This trial compares a vaccine called folate receptor alpha dendritic cells (FRαDCs) to a placebo in treating patients with advanced ovarian, fallopian tube, or peritoneal cancer.

Who is the study for?
This trial is for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer (stage III or IV). Specific eligibility criteria are not provided but typically include factors like age, overall health status, and the extent of disease progression.
What is being tested?
The trial is testing a new vaccine made from the patient's own white blood cells called FRαDCs against a placebo. The vaccine aims to boost the immune system to target and destroy tumor cells by recognizing a protein on them.
What are the potential side effects?
Potential side effects are not detailed here but may include reactions at the injection site, flu-like symptoms, fatigue due to immune response stimulation. As it's an investigational treatment, unexpected side effects could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but may not be able to do heavy physical work.
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I am 18 years old or older.
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My genetic tests for BRCA1/BRCA2 show no harmful mutations.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses besides my current condition.
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I have had radiation therapy for my cancer.
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I am immunocompromised or HIV positive and on antiretroviral therapy.
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I have a BRCA1 or BRCA2 gene mutation.
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My condition is currently showing signs or symptoms.
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I have a serious illness that is not under control.
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I had a heart attack in the last 6 months or have heart failure needing treatment for serious irregular heartbeats.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrence-free survival
Secondary study objectives
Incidence of adverse events (AEs)
Overall survival (OS)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (FRalphaDCs)Experimental Treatment8 Interventions
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.
Group II: Arm II (placebo)Placebo Group8 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Leukapheresis
2016
Completed Phase 2
~710
Computed Tomography
2017
Completed Phase 2
~2740
Tetanus and Diphtheria Toxoids Adsorbed
2019
Completed Phase 2
~400
Biospecimen Collection
2004
Completed Phase 3
~2020
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,318 Previous Clinical Trials
2,951,022 Total Patients Enrolled
10 Trials studying Ovarian Cancer
3,508 Patients Enrolled for Ovarian Cancer
Matthew S. Block, MD, PhDPrincipal InvestigatorMayo Clinic in Rochester
~52 spots leftby Dec 2027
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