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NCT02593227 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Breast Cancer, sponsored by Marker Therapeutics.

Completed
Registry status
Phase 2
Development phase
80
Enrollment target
11
Study locations

NCT02593227 is a Phase 2 study of Breast Cancer that has completed, run by Marker Therapeutics. The registered enrollment target is 80 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 11 study locations across 10 states.

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The verdict

NCT02593227, a Phase 2 study of Breast Cancer, has completed, sponsored by Marker Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
80 participants
Enrollment target
11
Study locations

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

7 total trials

What the Registry Record Tells You About NCT02593227

The ClinicalTrials.gov registry entry for NCT02593227 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Marker Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.

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.

NCT02593227 reports 11 study locations spanning 10 distinct geographic areas - top geographies include New York, Florida, Kansas.

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.

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).

Who is sponsoring clinical trial NCT02593227?

This trial is sponsored by Marker Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.

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.

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

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