NUTMEG
Trial status: CompletedProtocol title
Purpose of the study
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
Intervention
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.
Study Chair
Coordinating Centre
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: nutmeg.study@sydney.edu.au
Design
Phase II, multi-centre, open-label, parallel-arm
Cancer Type
Publications
- NUTMEG: A randomized phase II study of nivolumab and temozolomide versus temozolomide alone in newly diagnosed older patients with glioblastoma https://doi.org/10.1093/noajnl/vdad124