drugset / Trial / NCT04195139
Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM
Phase 2
Active not recruiting
103 enrolled
University of Sydney
Cooperative Trials Group for Neuro-Oncology · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-02-22
- Primary completion
- 2024-06-28
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | Temozolomide | Small molecule | 200 mg/m2 | Oral |