In this study we are evaluating the safety and feasibility of the triple combination (TTFields, MLA, pembrolizumab) in adult patients diagnosed with recurrent or progressive glioblastoma (GBM) WHO Grade IV, IDH wild type or recurrent or progressive astrocytoma WHO grade IV.
Patient must be at least 18 years of age.
Diagnosis of recurrent or progressive glioblastoma, WHO Grade IV, IDH wild-Type or astrocytoma WHO grade IV.
Unequivocal evidence of tumor progression by brain MRI scan per RANO criteria. Patients who experience a second disease progression are eligible provided that they have not been previously treated with anti-angiogenic agents including bevacizumab (at the exception of bevacizumab radiation necrotic protocol)
A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively, within 28 days prior to study enrollment.
Prior treatment with any anti-angiogenic agent, including bevacizumab.
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
Prior treatment with a monoclonal antibody within 4 weeks prior to the projected first dose of pembrolizumab or has not recovered (i.e. ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the projected first dose of pembrolizumab or has not recovered (i.e. ≤ grade 1 or at baseline) from adverse events due to a previously administered agent.
Parallel
Pembrolizumab
DrugKeytruda® is the trade name for pembrolizumab, which will be given as 200mg IV Q3 weeks. This treatment will continue for up to two years.
Optune GIO®
Device. . Optune GIO® TTFields treatment will begin 3-7 days prior to MLA for Arm1 and 3-10 days prior to MLA for Arm 2.
NeuroBlate®
DeviceTreatment with NeuroBlate will occur one time at the beginning of the study.
Number of participants experiencing a DLT after receiving the triple combination (TTFields, MLA, pembrolizumab) in adult patients diagnosed with recurrent glioblastoma from both arms
Patients who receive the combinatorial regimen will get the ongoing safety assessment with DLT \</= 33% treated subjects
Percentage of participants treated with the triple combination (TTFields, MLA, pembrolizumab) in adult patients diagnosed with recurrent glioblastoma from both arms
Feasibility is defined as the ability to successfully deliver the combinatorial treatment of MLA, optune GIO® and pembrolizumab to at least 67% of enrolled subjects who undergo MLA.
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