(2-THE-TOP) Phase 2, Single Arm, Historically Controlled Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients with Newly Diagnosed Glioblastoma


Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of the central nervous system in adults. Despite an aggressive multimodality treatment approach including surgery, radiation therapy and chemotherapy, overall survival remains poor. Pembrolizumab has recently been approved in the United States for the treatment of patients with advanced and metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, locally advanced urothelial carcinoma, classical Hodgkin lymphoma, unresectable or metastatic melanoma

This study is being performed to determine whether the triple combination of pembrolizumab when added to TTFields (Optune®) and adjuvant temozolomide increases progression-free survival (PFS) in patients with newly diagnosed GBM as compared to historical control data.


  • Ages 18 - 80 years old
  • Disease: Brain tumor
  • Disease type: Newly diagnosed Glioblastoma Multiforme (GBM)
For additional information about eligibility criteria, please contact the study coordinator

Deborah Sampson (deborah.sampson@neurosurgery.ufl.edu

(352) 273-9000


  • Drugs: Optune, Pembrolizumab, Temozolomide
  • Drug types: Immunotherapy, Chemotherapy
For additional information about study procedures, please contact the study coordinator Deborah Sampson (deborah.sampson@neurosurgery.ufl.edu

(352) 273-9000


18 to 65
65 and over



Can be done from home



Brain tumor - primary - adults, Brain Tumors, Brain Tumor

Principal Investigator

David Tran, MD, PhD



Contact Information


(352) 273-9000

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