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Trial Summary

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

Sponsor / Cooperative group:

University of Sydney

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.

Trial & Patient Characteristics

Cancer TypeBrain
Trial TypeTreatment
PhasePhase II
Age Range65 and older
SexBoth
Tumour StreamGlioblastoma
Cancer StageAll stages
Anticipated Start Date2018-01-15
Anticipated End Date2019-02-01

Participating Hospitals

HospitalRoyal Adelaide Hospital
Clinical Trial CoordinatorAnne Milton
Emailanne.milton@sa.gov.au
Phone08 7074 2342
Principal InvestigatorDr Hien Le
Recruitment StatusRecruiting