An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma

Trial Profile

An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma

Discontinued
Phase of Trial: Phase III

Latest Information Update: 22 Aug 2017

At a glance

  • Drugs Rindopepimut (Primary) ; Keyhole limpet haemocyanin; Sargramostim; Temozolomide
  • Indications Glioblastoma; Gliosarcoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ACT-IV
  • Sponsors Celldex Therapeutics Inc
  • Most Recent Events

    • 22 Aug 2017 Primary endpoint (Overall Survival) has not been met as per the results published in the Lancet Oncology
    • 22 Aug 2017 Results published in the Lancet Oncology
    • 08 Aug 2016 According to a Celldex Therapeutics Inc media release, all patients from the Rindopepimut (RINTEGA) arm of the study have been offered ongoing access to RINTEGA on a compassionate use basis.
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