Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Brain Tumor
- GBM
- Glioblastoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion). The main purpose of Part 1 is Dose-Escalation. "Dose-Escalation" means that different dose levels will be tested at different times during the study to find the best dose level that is safe and well tolerated in p...
There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion). The main purpose of Part 1 is Dose-Escalation. "Dose-Escalation" means that different dose levels will be tested at different times during the study to find the best dose level that is safe and well tolerated in participants. In this study investigators will determine the best dose of Vorinostat that can be given with pembrolizumab, chemotherapy and radiotherapy. The dose of temozolomide and radiotherapy will be the same as standard treatment. Part 2 (Dose Expansion), all participants will receive the same dose of vorinostat with pembrolizumab, chemotherapy and radiotherapy. Maintenance Phase: During the maintenance phase, participants will receive Temozolomide (for the first 6 months), vorinostat (for 12 months), and pembrolizumab (for 12 months).
Tracking Information
- NCT #
- NCT03426891
- Collaborators
- Merck Sharp & Dohme Corp.
- Investigators
- Principal Investigator: Solmaz Sahebjam, M.D. H. Lee Moffitt Cancer Center and Research Institute
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