OPTIMUS PRIME: Safety and Feasibility of OPTune GIO® Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa, A randomizEd Trial
University of Florida
Summary
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.
Description
Twenty patients diagnosed with recurrent or progressive glioblastoma will be enrolled in this pilot study of safety and feasibility and receive the triple combination of Optune GIO®, MLA and pembrolizumab. Patients will be identified and enrolled prior to initiation of treatment for recurrence and be randomized (1:1) to (each arm has 10 patients): Arm 1: Optune GIO® pre-MLA; MLA; followed by Optune GIO® + Pembrolizumab post MLA Arm 2: Optune GIO®+Pembrolizumab pre-MLA; MLA; followed by Optune GIO® + Pembrolizumab post MLA Surgical resection/debulking is per standard of care and optional fo…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient must be at least 18 years of age. 2. Diagnosis of recurrent or progressive glioblastoma, WHO Grade IV, IDH wild-Type or astrocytoma WHO grade IV. 3. 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) 4. A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively, within 28 days prior to s…
Interventions
- DrugPembrolizumab
Keytruda® is the trade name for pembrolizumab, which will be given as 200mg IV Q3 weeks. This treatment will continue for up to two years.
- DeviceOptune GIO®
. . Optune GIO® TTFields treatment will begin 3-7 days prior to MLA for Arm1 and 3-10 days prior to MLA for Arm 2.
- DeviceNeuroBlate®
Treatment with NeuroBlate will occur one time at the beginning of the study.
Location
- UF Health Shands HospitalGainesville, Florida