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COMPLETED Phase 2

Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer

NCT02593227 · View on ClinicalTrials.gov ↗

Study Summary

This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate Receptor Alpha (FRα) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant or adjuvant treatment of patients with Stage IIb-III triple negative breast cancer (TNBC).

Conditions Studied

Interventions

  • DRUG Cyclophosphamide
  • BIOLOGICAL Low dose FRα vaccine
  • BIOLOGICAL High dose FRα vaccine

Study Locations (11)

New York

  • Mount Sinai Hospital — New York
  • Montefiore Medical Center, Einstein Cancer Center — New York

Florida

  • Moffitt Cancer Center — Tampa

Kansas

  • University of Kansas Cancer Center — Westwood

Maryland

  • University of Maryland - Greenebaum Cancer Center — Baltimore

Michigan

  • Karmanos Cancer Center — Detroit

Missouri

  • MidAmerica Division,Inc — Kansas City

New Jersey

  • The Valley Hospital — Paramus

Ohio

  • Oncology Hematology Care — Cincinnati

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2016-04
Est. Completion 2021-07-15
Phase Phase 2

Sponsor

Marker Therapeutics

30 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02593227

The ClinicalTrials.gov registry entry for NCT02593227 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Marker Therapeutics, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02593227 reports 11 study locations spanning 10 distinct geographic areas — top geographies include New York, Florida, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02593227 about?

NCT02593227 is a clinical study titled "Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer". This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate Receptor Alpha (FRα) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant or adjuvant treatment of patients ...

What is the current status of trial NCT02593227?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2016-04. Estimated completion is 2021-07-15.

What conditions does trial NCT02593227 study?

This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02593227?

The interventions under investigation include: Cyclophosphamide (DRUG), Low dose FRα vaccine (BIOLOGICAL), High dose FRα vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02593227?

This trial is sponsored by Marker Therapeutics, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02593227 being conducted?

This trial has 11 study locations across Florida, Kansas, Maryland, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial