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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

NCT06558214 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-07

No results posted yet for this 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.

Conditions

Interventions

DRUG

Pembrolizumab

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.

DEVICE

Optune 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.

DEVICE

NeuroBlate®

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

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Ashley Ghiaseddin, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2029-10-31
Completion
2029-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06558214 on ClinicalTrials.gov