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NCT06558214 · ClinicalTrials.gov registry record · Phase 2
OPTIMUS PRIME: Safety and Feasibility of OPTune GIO® Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa, A randomizEd Trial
A Phase 2 study of Recurrent Glioblastoma, sponsored by University of Florida.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06558214: Recruiting Phase 2 study of Recurrent Glioblastoma, sponsored by University of Florida.
NCT06558214 is a Phase 2 study of Recurrent Glioblastoma that is actively recruiting participants, run by University of Florida. The registered enrollment target is 20 participants, below the 69-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06558214, a Phase 2 study of Recurrent Glioblastoma, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Patients who receive the combinatorial regimen will get the ongoing safety assessment with DLT \</= 33% treated subjects
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DEVICE Optune GIO®
- DEVICE NeuroBlate®
Study Locations (1)
Florida
- UF Health Shands Hospital - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-12-10 |
| Est. Completion | 2029-10 |
| Phase | Phase 2 |
What NCT06558214 shows while recruiting
NCT06558214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 69-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Recurrent Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT06558214 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06558214 about?
NCT06558214 is a clinical study titled "OPTIMUS PRIME: Safety and Feasibility of OPTune GIO® Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa, A randomizEd Trial". 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.
What is the current status of trial NCT06558214?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2024-12-10. Estimated completion is 2029-10.
What conditions does trial NCT06558214 study?
This clinical trial studies the following conditions: Recurrent Glioblastoma.
What interventions are being tested in trial NCT06558214?
The interventions under investigation include: Pembrolizumab (DRUG), Optune GIO® (DEVICE), NeuroBlate® (DEVICE).
Who is sponsoring clinical trial NCT06558214?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06558214 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06558214's enrollment target sits among peer trials
20 44th of 62 higher than 17 of 62 other Recurrent Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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