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A Phase II Clinical Trial of Pembrolizumab (Keytruda®) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer

Trial Profile

A Phase II Clinical Trial of Pembrolizumab (Keytruda®) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer

Planning
Phase of Trial: Phase II

Latest Information Update: 27 Nov 2018

At a glance

  • Drugs AE 37 (Primary) ; Pembrolizumab (Primary)
  • Indications Advanced breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Antigen Express; Generex Biotechnology Corporation
  • Most Recent Events

    • 27 Nov 2018 According to a Generex Biotechnology Corporation media release, the company has signed a clinical trial agreement (CTA) with the NSABP Foundation, Inc. (NSABP), to manage the trial. The trial is currently being reviewed by the FDA, and clinical operations including site qualification, drug shipment and packaging, and IRB review and approval are underway, with plans to enroll patients in the first quarter of 2019.
    • 05 Oct 2018 According to a Generex Biotechnology Corporation media release, the company will file an Investigational New Drug Application (IND) in October to initiate this trial. It is anticipated that the trial will initiate sites in the fourth quarter and begin enrolling patients in the first quarter of 2019.
    • 04 Jan 2018 According to a Generex media release, this trial is scheduled to enroll the first patient in mid-2018, with enrollment expected to take roughly 18 months.
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