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A Randomized, Double-blinded, Placebo-controlled Study of (ERC1671/GM-CSF/Cyclophosphamide)+Bevacizumab vs. (Placebo Injection/Placebo Pill) +Bevacizumab in the Treatment of Recurrent/Progressive, Bevacizumab naïve Glioblastoma Multiforme and Glioasarcoma Patients (WHO Grade IV Malignant Gliomas, GBM)

Trial Profile

A Randomized, Double-blinded, Placebo-controlled Study of (ERC1671/GM-CSF/Cyclophosphamide)+Bevacizumab vs. (Placebo Injection/Placebo Pill) +Bevacizumab in the Treatment of Recurrent/Progressive, Bevacizumab naïve Glioblastoma Multiforme and Glioasarcoma Patients (WHO Grade IV Malignant Gliomas, GBM)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 21 May 2022

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At a glance

  • Drugs ERC 1671 (Primary) ; Bevacizumab; Cyclophosphamide; Sargramostim
  • Indications Glioblastoma; Gliosarcoma
  • Focus Registrational; Therapeutic Use
  • Sponsors Epitopoietic Research Corporation
  • Most Recent Events

    • 20 Jul 2021 Status changed from recruiting to active, no longer recruiting.
    • 07 Apr 2021 According to a University of California media release, the FDA has recommended early termination of this trial in a letter dated April 2, 2021 and recommended to pursue a randomized confirmatory Phase 3 registration trial to support a licensing application in the form of a biologics license application (BLA).
    • 19 Aug 2020 According to an Epitopoietic Research Corporation media release, this trial is under FDA IND 15430 at the University of California, Irvine Medical Center in Orange, California.
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