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NCT04195139 · ClinicalTrials.gov registry record · Phase 2
Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM
A Phase 2 study of Glioblastoma Multiforme, sponsored by University of Sydney.
- Active
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
- 20
- Study locations
NCT04195139: Active Phase 2 study of Glioblastoma Multiforme, sponsored by University of Sydney.
NCT04195139 is a Phase 2 study of Glioblastoma Multiforme that is active but no longer recruiting, run by University of Sydney. The registered enrollment target is 103 participants, roughly in line with the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target. The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04195139, a Phase 2 study of Glioblastoma Multiforme, is active but no longer recruiting, sponsored by University of Sydney.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Overall survival is defined as the interval from the date of randomisation to date of death from any cause, or date of last known follow-up alive. This will be calculated using the Kaplan-Meier method.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Temozolomide
Study Locations (20)
New South Wales
- Campbelltown Hospital - Campbelltown
- Chris O'Brien Lifehouse - Camperdown
- Gosford Hospital - Gosford
- Newcastle Private Hospital - New Lambton Heights
- Port Macquarie Hospital - Port Macquarie
- Prince of Wales Hospital - Randwick
- Royal North Shore Hospital - Saint Leonards
- Wollongong Hospital - Wollongong
Victoria
- Monash Medical Centre - Clayton
- Austin Hospital - Heidelberg
- Peter MacCallum Cancer Centre - Melbourne
- Epworth Healthcare - Richmond
Queensland
- Royal Brisbane and Women's Hospital - Herston
- Icon Cancer Centre - South Brisbane
- Princess Alexandra Hospital - Woolloongabba
South Australia
- Royal Adelaide Hospital - Adelaide
- Flinders Medical Centre - Bedford Park
North Carolina
- Duke University Medical Center - Durham
Tasmania
- Royal Hobart Hospital - Hobart
Western Australia
- Sir Charles Gairdner Hospital - Nedlands
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2018-02-22 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04195139 still lists
NCT04195139 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target.
The record links to 1 condition, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT04195139 names 20 study sites across 7 states, led by New South Wales, Victoria, Queensland.
Frequently Asked Questions
What is clinical trial NCT04195139 about?
NCT04195139 is a clinical study titled "Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM". 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...
What is the current status of trial NCT04195139?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2018-02-22. Estimated completion is 2025-12-31.
What conditions does trial NCT04195139 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme.
What interventions are being tested in trial NCT04195139?
The interventions under investigation include: Nivolumab (DRUG), Temozolomide (DRUG).
Who is sponsoring clinical trial NCT04195139?
This trial is sponsored by University of Sydney, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04195139 being conducted?
This trial has 20 study locations across North Carolina, New South Wales, Queensland, South Australia, Tasmania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioblastoma Multiforme
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04195139's enrollment target sits among peer trials
103 16th of 88 higher than 73 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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