drugset / Trial / NCT03426891
Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma
Phase 1
Completed
21 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Merck Sharp & Dohme LLC · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this research study is to test the safety and tolerability of the combination treatment of the investigational drugs vorinostat and pembrolizumab, in combination with chemotherapy (temozolomide), and radiotherapy. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and lung cancer and vorinostat to treat some forms of blood and lymph node cancers. However, both vorinostat and pembrolizumab are considered investigational drugs in this study because they are not approved for treatment of glioblastoma.
Timeline
- Start
- 2018-03-16
- Primary completion
- 2021-10-18
- Completion
- 2023-06-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Vorinostat | Small molecule | 300 mg | — |
| Subject | Vorinostat | Small molecule | 400 mg | — |
| Background | Temozolomide | Small molecule | 150 mg/m2 | Oral |
| Background | Temozolomide | Small molecule | 200 mg/m2 | Oral |