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

NCT02593227 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-07-19

No results posted yet for this 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

Interventions

BIOLOGICAL

Low dose FRα vaccine

165ug per peptide ID injection

DRUG

Cyclophosphamide

IV infusion over 1 hour

BIOLOGICAL

High dose FRα vaccine

500ug per peptide ID injection

Sponsors & Collaborators

  • Marker Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Kenney, MD · Marker Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2021-07-15
Completion
2021-07-15

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02593227 on ClinicalTrials.gov