This Phase II, open-label, randomized study (NUTMEG; ACTRN12617000267358) compares standard radiotherapy combined with temozolomide against the same regimen plus nivolumab, in elderly patients (≥70, or 65–69 if standard radiotherapy isn’t feasible) with newly diagnosed glioblastoma. The primary endpoint is overall survival, while secondary outcomes include 6-month progression-free survival, adverse events (per CTCAE v4.03), quality of life (EORTC QLQ-C30, BN-20, EQ-5D-5L), neurological function (NANO Scale), and correlation of RANO with immune-related RANO
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: nutmeg.study@sydney.edu.au
Control Arm: All patients will receive radiotherapy (40Gy/ 15 fractions, weekdays over 21 days) concurrently with temozolomide (TMZ) tablets 75mg/m2 daily for 21 days.
Experimental Arm: 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.
NUTMEG: A randomized phase II study of nivolumab and temozolomide versus temozolomide alone in newly diagnosed older patients with glioblastoma,
Mustafa Khasraw, Kerrie McDonald, Sonia Yip, Roel Verhaak, Amy Heimberger, Merryn Hall, Lauren Fisher, Elizabeth Barnes, Mark Rosenthal, Craig Gedye, Elizabeth Hovey, Benjamin Ellingson, John Simes, Annette Tognela, Eng-Siew Koh, Hui Gan, Michael Back, Zarnie Lwin, RBTT-07.
https://doi.org/10.1093/noajnl/vdad124
17 Participating Sites
103 Recruitment Target
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
