A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma

Trial Profile

A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma

Recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Aug 2017

At a glance

  • Drugs Nivolumab (Primary) ; Temozolomide
  • Indications Glioblastoma
  • Focus Registrational; Therapeutic Use
  • Acronyms CheckMate 548
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 19 Jul 2017 Planned End Date changed from 9 Nov 2020 to 8 Jan 2023.
    • 19 Jul 2017 Planned primary completion date changed from 12 Jun 2019 to 6 Nov 2021.
    • 26 Jun 2017 Planned number of patients changed from 320 to 693.
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