RecruitingPhase 2NCT06558214

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


Sponsor

University of Florida

Enrollment

20 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study (called OPTIMUS PRIME) is testing a combination of three treatments for people with recurring glioblastoma (a serious brain cancer that has come back): laser surgery to destroy the tumor from the inside, a device called Optune GIO® (which uses electric fields to kill cancer cells), and the immunotherapy drug pembrolizumab. **You may be eligible if...** - You are 18 or older with confirmed recurrent or progressive glioblastoma (Grade IV brain cancer) - Your tumor recurrence is clearly visible on MRI - You have a reasonable functional status (Karnofsky score ≥ 60%) - You are a candidate for the laser surgery, Optune device, and pembrolizumab based on your doctor's assessment - Your blood counts, liver, and kidneys are functioning adequately **You may NOT be eligible if...** - You have previously received anti-angiogenic drugs like bevacizumab (with rare exceptions) - You have received prior anti-PD-1 or PD-L1 immunotherapy - You have active autoimmune disease - You are pregnant or breastfeeding - You have a device incompatible with the Optune therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

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.

DEVICEOptune 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.

DEVICENeuroBlate®

Treatment with NeuroBlate will occur one time at the beginning of the study.


Locations(1)

UF Health Shands Hospital

Gainesville, Florida, United States

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NCT06558214


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