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Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM
NCT04195139 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04195139
The ClinicalTrials.gov registry entry for NCT04195139 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Sydney, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04195139 reports 20 study locations spanning 7 distinct geographic areas — top geographies include New South Wales, Victoria, Queensland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04195139?
The interventions under investigation include: Nivolumab (DRUG), Temozolomide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04195139?
This trial is sponsored by University of Sydney, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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