NCT06558214

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 for the purpose of this study. The performing neurosurgeon will determine whether each patient will undergo surgery. For patients who undergo debulking surgery, MLA is expected to occur between 3-6 weeks post-surgery, when the performing surgeon assesses the procedure is safe. Patients randomized to treatment arm 1 will start treatment with Optune GIO® for 3-7 days and undergo MLA and biopsy for tumor diagnosis and immune monitoring. Treatment with Optune GIO® will be paused prior to the MLA procedure until at least 10 days post MLA. Patients will then resume treatment with Optune GIO® and receive pembrolizumab 200 mg IV every 3 weeks (+/- 4 days) starting no sooner than 1 week after the start of Optune GIO®. Patients randomized to treatment arm 2, will start treatment with Optune GIO® for 3-10 days and receive one infusion of pembrolizumab before undergoing MLA/biopsy. Patients will resume Optune GIO® no earlier than 10 days post-surgery and receive pembrolizumab 200 mg IV every 3 weeks (+/- 4 days) starting no sooner than 1 week after the start of Optune GIO®, Post MLA, patients may continue treatment with Optune GIO® and pembrolizumab for up to 2 years, or until disease progression, intolerable toxicity, whichever comes first.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	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.
DEVICE	Optune 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.
DEVICE	NeuroBlate®	Treatment with NeuroBlate will occur one time at the beginning of the study.

Timeline

• Start date: 2024-12-10
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2024-08-16
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study