(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

Purpose

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.

Eligibility

  • 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 Sonisha Warren:

Procedures

  • Drugs: Optune, Pembrolizumab, Temozolomide
  • Drug types: Immunotherapy, Chemotherapy
For additional information about study procedures, please contact the study coordinator Sonisha Warren:

Age

18 to 65
65 and over

Gender

Male
Female

Can be done from home

No

Keywords

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

Principal Investigator

David Tran, MD, PhD

Department

Neurosurgery

Contact Information

sonisha.warren@neurosurgery.ufl.edu

(352) 294-8737

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