OPTIMUS PRIME: Safety and Feasibility of OPTune GIO® Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa, A randomizEd Trial

Required: IDH1 wild-type

Required: IDH2 wild-type

Cannot have received: anti-angiogenic agent (bevacizumab)

Exception: bevacizumab radiation necrotic protocol

Prior treatment with any anti-angiogenic agent, including bevacizumab (at the exception of bevacizumab radiation necrotic protocol)

Cannot have received: anti-PD-1 therapy

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)

Cannot have received: monoclonal antibody

Exception: allowed if >4 weeks prior and recovered to ≤ grade 1 or baseline from adverse events

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

Cannot have received: chemotherapy

Exception: allowed if >2 weeks prior and recovered to ≤ grade 1 or baseline from adverse events; ≤ grade 2 neuropathy is an exception

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. Note: patients with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.

Cannot have received: targeted small molecule therapy

Exception: allowed if >2 weeks prior and recovered to ≤ grade 1 or baseline from adverse events; ≤ grade 2 neuropathy is an exception

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. Note: patients with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.

Cannot have received: radiation therapy

Exception: allowed if >2 weeks prior and recovered to ≤ grade 1 or baseline from adverse events; ≤ grade 2 neuropathy is an exception

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. Note: patients with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.

Cannot have received: local therapy (stereotactic radiosurgery, brachytherapy, carmustine wafers)

Received prior local therapy (stereotactic radiosurgery, brachytherapy, or carmustine wafers) to the proposed area of MLA treatment