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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

February 22, 2018

Primary Completion Date

June 28, 2024

Study Completion Date

December 31, 2025

Conditions
Glioblastoma Multiforme
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.

Trial Locations (20)

2031

Prince of Wales Hospital, Randwick

2050

Chris O'Brien Lifehouse, Camperdown

2065

Royal North Shore Hospital, Saint Leonards

2250

Gosford Hospital, Gosford

2305

Newcastle Private Hospital, New Lambton Heights

2444

Port Macquarie Hospital, Port Macquarie

2500

Wollongong Hospital, Wollongong

2560

Campbelltown Hospital, Campbelltown

3000

Peter MacCallum Cancer Centre, Melbourne

3084

Austin Hospital, Heidelberg

3121

Epworth Healthcare, Richmond

3168

Monash Medical Centre, Clayton

4029

Royal Brisbane and Women's Hospital, Herston

4101

Icon Cancer Centre, South Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

5000

Royal Adelaide Hospital, Adelaide

5042

Flinders Medical Centre, Bedford Park

6009

Sir Charles Gairdner Hospital, Nedlands

7000

Royal Hobart Hospital, Hobart

27710

Duke University Medical Center, Durham

All Listed Sponsors
collaborator

Cooperative Trials Group for Neuro-Oncology

UNKNOWN

lead

University of Sydney

OTHER

NCT04195139 - Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM | Biotech Hunter | Biotech Hunter