drugset / Trial / NCT03426891

Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma

NCT03426891

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

EvaluationDrugModalityDoseRoute
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