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Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM

Study acronym: NUTMEG
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Dec 31, 2024 to Jun 28, 2024v6
  2. Primary completion date: Dec 31, 2023 to Dec 31, 2024
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    • Eligibility criteria revised
    v5
  3. Primary completion date: Dec 31, 2021 to Dec 31, 2023
    • Study completion date: Dec 31, 2022 to Dec 31, 2024
    • Secondary endpoints revised (7)
    • Collaborators: 2 to 1
    v4
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 102 to confirmed 103
    • Site details revised at 20 of 20 sites
    v3
  5. Eligibility criteria expanded, about 25 words
    • Site details revised at 5 of 20 sites
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Sydney
35 trials monitored
See 1 trial at risk
Glioma
1,251 trials monitored
See 88 trials at risk
Glioblastoma
710 trials monitored
See 52 trials at risk
This study aims to investigate effect of Nivolumab and Temozolomide vs Temozolomide alone on overall survival in newly diagnosed elderly patients with glioblastoma. Who is it for? You may be eligible to join this study if you are aged 65 years or above, with newly diagnosed histologically confirmed GBM (WHO grade IV glioma including gliosarcoma) following surgery. The study aims to evaluate whether the combination of adjuvant nivolumab with temozolomide improves overall survival outcomes for this patient population. The outcome of the study will help determine the most effective treatment for patients with glioblastoma in the future.
Trial Details
NCT Number NCT04195139
Lead Sponsor University of Sydney
Collaborators: Cooperative Trials Group for Neuro-Oncology
Conditions
(from sponsor)		 Glioblastoma Multiforme
Related terms Glioblastoma
Enrollment 103 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov