Clinical Trial

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

Study acronym: OPTIMUS PRIME
Recruiting Phase 2
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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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2024-08-14; most recent amendment 2026-01-06.
Status change: Not Yet Recruiting → Recruiting 2024-11-13
Trial Details
NCT Number NCT06558214
Lead Sponsor University of Florida
Conditions Recurrent Glioblastoma
Enrollment 20 participants
Start Date 2024-12-10
Primary Completion 2029-10 (estimated)
Study Completion 2029-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-07