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OPTIMUS PRIME: Study for Recurrent Glioblastoma

This study, called OPTIMUS PRIME, is looking at the safety and how well a combination of treatments works for adults with recurrent glioblastoma (a type of brain cancer that has come back) or astrocytoma. The treatments include Pembrolizumab (Keytruda®), a drug given through an IV, Optune GIO® (a device that uses electric fields), and NeuroBlate® (a device for MRI-guided laser ablation surgery). We want to see how many people experience side effects and how many can complete this triple treatment. You may be able to join if you are 18 to 90 years old and have recurrent glioblastoma or astrocytoma that has progressed.

Study design
This is a pilot study involving 20 participants with recurrent glioblastoma, who will be randomly assigned to one of two treatment groups.
What's involved
Participants will receive Pembrolizumab for up to two years, Optune GIO® treatment, and a one-time NeuroBlate® surgery. The exact schedule for Optune GIO® and Pembrolizumab will depend on which group you are in.
Compensation
Not stated in the trial record.
Follow-up
The main safety and feasibility outcomes will be measured from the start of treatment up to 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06558214

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

Recruiting
PHASE2Ages 18–90InterventionalTreatment
University of Florida
~20 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:PembrolizumabOptune GIO®NeuroBlate®

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants experiencing a DLT after receiving the triple combination (TTFields, MLA, pembrolizumab) in adult patients diagnosed with recurrent glioblastoma from both arms
Measured over baseline up to 3 months
+1 more outcome measured

Conditions

Recurrent Glioblastoma

Explore related trials

AstrocytomaGlioblastoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Ashley Ghiaseddin, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Victoria Hope
[email protected]
352-273-9000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Amenorrhea that has lasted for ≥ 12 consecutive months without another cause, or
For women with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL. 2. Males with female partners of childbearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug. 12. Ability of the patient to understand and willingness to sign an IRB approved written informed consent document

What this trial measures

  • Number of participants experiencing a DLT after receiving the triple combination (TTFields, MLA, pembrolizumab) in adult patients diagnosed with recurrent glioblastoma from both armsbaseline up to 3 months

    Patients who receive the combinatorial regimen will get the ongoing safety assessment with DLT \</= 33% treated subjects

  • Percentage of participants treated with the triple combination (TTFields, MLA, pembrolizumab) in adult patients diagnosed with recurrent glioblastoma from both armsbaseline up to 3 months

    Feasibility is defined as the ability to successfully deliver the combinatorial treatment of MLA, optune GIO® and pembrolizumab to at least 67% of enrolled subjects who undergo MLA.