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ACTIVE NOT RECRUITING
NCT04195139
PHASE2

Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM

Sponsor: University of Sydney

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DRUG

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