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Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM
Sponsor: 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. 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.
Official title: A Randomised Phase II Study of NivolUmab and TeMozolomide vs Temozolomide Alone in Newly Diagnosed Elderly Patients With Glioblastoma (NUTMEG)
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
103
Start Date
2018-02-22
Completion Date
2025-12-31
Last Updated
2024-12-11
Healthy Volunteers
No
Conditions
Interventions
Nivolumab
Participants 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).
Temozolomide
Participants will receive temozolomide (TMZ) 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.
Locations (20)
Duke University Medical Center
Durham, North Carolina, United States
Campbelltown Hospital
Campbelltown, New South Wales, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
Newcastle Private Hospital
New Lambton Heights, New South Wales, Australia
Port Macquarie Hospital
Port Macquarie, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Icon Cancer Centre
South Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Epworth Healthcare
Richmond, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia