Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 51
Summary
- Conditions
- Recurrent Glioblastoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Primary objective: Assess clinical activity of Pembrolizumab and SurVaxM in participants with recurrent glioblastoma using progression free survival at 6 months (PFS-6). Secondary objective: : Assess safety and tolerability of Pembrolizumab and SurVaxM in participants with recurrent glioblastoma. Th...
Primary objective: Assess clinical activity of Pembrolizumab and SurVaxM in participants with recurrent glioblastoma using progression free survival at 6 months (PFS-6). Secondary objective: : Assess safety and tolerability of Pembrolizumab and SurVaxM in participants with recurrent glioblastoma. This is a Phase II study of two arms in participants with recurrent glioblastoma. Arm A will include participants with first recurrence of glioblastoma who have failed prior chemotherapy and radiation but have not received any immunotherapy. Arm B is an exploratory arm of 10 participants who have failed prior anti-PD1 therapy. All patients will receive the study drug combination consisting of SurVaxM and pembrolizumab (PEM) with no randomization, stratification or dose escalation.
Tracking Information
- NCT #
- NCT04013672
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David Peereboom, MD Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
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