drugset / Trial / NCT03425292
A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to test the safety and tolerability of the research study drugs nivolumab, ipilimumab, lomustine, bevacizumab, and temozolomide when used following surgery and before standard therapy with radiation and temozolomide in patients with newly diagnosed high grade glioma. Additional aims of the study are to: * Find out side effects (good and bad) of study drug combinations. * Evaluate any preliminary evidence of anticancer activity of study drug combinations . * Evaluate tumor characteristics by collecting brain tumor tissue samples. * Measure the amount of nivolumab and ipilimumab in biospecimens. * Look at biomarkers in biospecimens.
Timeline
- Start
- 2018-03-01
- Primary completion
- 2022-09-12
- Completion
- 2023-10-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Lomustine | Small molecule | 100 mg/m2 | Oral |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 300 mg | Intravenous |
| Subject | Temozolomide | Small molecule | 100 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 150 mg/m2 | Oral |