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Brief Title: Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence
Official Title: Phase II Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence
Study ID: NCT04013672
Brief Summary: The main purpose of this study is to assess the clinical activity of Pembrolizumab and SurVaxM in participants with recurrent glioblastoma.
Detailed 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. 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Name: David Peereboom, MD
Affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR