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  • NUTMEG

    Acronym: 

    NUTMEG

    ACTRN/NCT /ethics: 

    ACTRN12617000267358

    Scientific title: 

    A randomised phase II study of nivolumab and temozolomide vs. temozolomide alone in newly diagnosed elderly patients with glioblastoma (NUTMEG)

    Summary of trial and patient characteristics

    Cancer Type Brain & central nervous system
    Trial Type Treatment
    Phase Phase II Tumour Stream Glioblastoma
    Age Range 65 and older Cancer Stage All stages
    Sex Both Anticipated Start Date 2018-01-15
    Molecular Target Anticipated End Date 2019-02-01
    Cancer Type Brain & central nervous system
    Trial Type Treatment
    Phase Phase II
    Age Range 65 and older
    Sex Both
    Molecular Target
    Tumour Stream Glioblastoma
    Cancer Stage All stages
    Anticipated Start Date 2018-01-15
    Anticipated End Date 2019-02-01

    Trial Summary

    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. Study details Participants will be allocated to either experimental or control group in a 2:1 ratio by chance (randomly). Patients assigned to the experimental group will receive a course of nivolumab via intravenous infusion (240 mg on days 1 and 15 every 28 days for cycles 1-4; then 480 mg day 1 every 28 days for cycles 5-6) in addition to the standard regimen of Temozolomide (TMZ) tablets and radiotherapy. Patients assigned to the control group will receive the standard treatment of adjuvant temozolomide (150-200mg/m2 days 1-5 every 28 days) for 6 cycles and standard radiotherapy treatment (40 Gy administered in 15 fractions). 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.

    Lay Summary

    A randomised phase II study of nivolumab and temozolomide vs. temozolomide alone in newly diagnosed elderly patients with glioblastoma (NUTMEG)

    Sponsor / Cooperative group

    University of Sydney

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Ganessan Kichenadasse Not Yet Recruiting