Spots Global Cancer Trial Database for Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM
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Trial Identification
Brief Title: Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM
Official Title: A Randomised Phase II Study of NivolUmab and TeMozolomide vs Temozolomide Alone in Newly Diagnosed Elderly Patients With Glioblastoma (NUTMEG)
Study ID: NCT04195139
Conditions
Study Description
Brief 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.
Detailed Description: 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).
Eligibility
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Mustafa Khasraw
Affiliation: Duke University
Role: STUDY_CHAIR
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