(2-THE-TOP) Phase 2, Single Arm, Historically Controlled Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (OptuneÂ®) 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)
- (352) 294-8836
- Drugs: Optune, Pembrolizumab, Temozolomide
- Drug types: Immunotherapy, Chemotherapy
- (352) 294-8836
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KeywordsBrain tumor - primary - adults, Brain Tumors, Brain Tumor
Principal InvestigatorDavid Tran, MD, PhD
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