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A Randomised Phase II Study of NivolUmab and TeMozolomide vs Temozolomide alone in newly diagnosed Elderly patients with Glioblastoma (NUTMEG) to analyse overall survival.
Other Non-Commercial Sponsor
National Health & Medical Research Council (NHMRC)
All patients will receive radiotherapy (40Gy/ 15 fractions, weekdays over 21 days) concurrently with temozolomide (TMZ) tablets 75mg/m2 daily for 21 days.
After a 4 week break the experimental group will receive nivolumab intravenous infusions (240 mg days 1 and 15 every 28 days for cycles 1-4; then 480 mg day 1 every 28 days for cycles 5-6) with concurrent adjuvant temozolomide tablets days 1-5, every 28 days) for 6 cycles. TMZ will be dosed at 150mg/m2 for the first cycle. If well tolerated TMZ is then given at 200mg/m2 for cycles 2 - 6.
The intervention will not be personalised.