Phase II randomised, multisite study of Nivolumab and Temozolomide vs Temozolomide alone in newly diagnosed Elderly patients with Glioblastoma.

Glioblastoma (GBM, astrocytoma WHO Grade IV) is the most common brain tumour in adults, representing approximately 80% of all primary malignant brain tumours. The median age at diagnosis is > 64 years. Survival is worse in older patients, who represent the majority of GBM cases. Sadly, many do not live more than 10 months beyond the diagnosis.

COGNO has gained ethical approval to run a new clinical trial aimed at testing the effectiveness, safety and tolerability of an immunotherapy treatment (nivolumab) in combination with standard chemotherapy with temozolomide (TMZ) to see if this improves the overall survival of GBM patients aged 65 years or older. The NUTMEG (NivolUmab and TeMozolomide vs Temozolomide alone in newly diagnosed Elderly patients with Glioblastoma) trial aims to recruit 102 patients across approximately 18 sites in Australia, beginning in early 2018. Depending on the results, the study team may extend NUTMEG into a subsequent larger trial (Phase III). The importance of this trial is that it is focussing on the elderly population, who are usually excluded from participating in GBM clinical trials.

The NUTMEG trial has a comprehensive research plan, using advanced MRIs, tissue and DNA analysis to understand the function and key pathways of the immune system in GBM. The trial will also investigate patient subgroups based on biomarker analyses to determine who may derive greater benefit from immunotherapy treatments such as nivolumab.

See ANZCTR for full trial details >


Trial Summary:

The aim of the study is to evaluate whether the combination of adjuvant nivolumab with temozolomide improves overall survival outcomes of GBM patients who are 65 years of age or older.

Supported By:

NHMRC grant and BMS (Drug supply), COGNO, NHMRC CTC


Adults, aged ≥70 years, or aged 65-69 years if long course RT is inappropriate, with newly diagnosed histologically confirmed GBM (WHO grade IV glioma including gliosarcoma) following surgery.

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A/Prof Mustafa Khasraw