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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
StatusRecruiting
PhasePhase 2
Started2024-12-10
View on ClinicalTrials.gov ↗

Amendment history

2026-01-06
3 amendments v6-v8
3 re-verifications since 2025-09-15, no change to tracked fields
2025-06-30
Study Status v5
Start date2024-11-12→2024-12-10
2025-03-04
Study Status v4
Re-verified, no change to tracked fields
2024-11-13
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10-30→confirmed 2024-11-12
Study sites0→1
2024-10-14
2 amendments v1-v2
2 re-verifications since 2024-09-11, no change to tracked fields
2024-08-14
Original filing
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.
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 2026-09-23