Actively Recruiting
OPTIMUS PRIME: Safety and Feasibility of OPTune GIO® Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa, A randomizEd Trial
Led by University of Florida · Updated on 2026-01-07
20
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
OPTIMUS PRIME: Safety and Feasibility of OPTune GIO® Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa, A randomizEd Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Diagnosed with recurrent or progressive glioblastoma WHO Grade IV, IDH wild type, or astrocytoma WHO grade IV
- Evidence of tumor progression by brain MRI per RANO criteria
- Diagnostic contrast-enhanced brain MRI within 28 days before enrollment
- At least 12 weeks since finishing radiation therapy unless clear tumor recurrence confirmed
- Karnofsky performance status of 60% or higher
- Candidate for MRI-guided laser ablation (MLA) as determined by neurosurgeon
- Candidate for Optune GIO4 therapy
- Candidate for pembrolizumab treatment
- Adequate bone marrow and organ function (specific lab values required)
- Women of childbearing potential must use effective contraception during and 24 weeks after study
- Male participants with female partners of childbearing potential must use contraception during and 24 weeks after study
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior treatment with any anti-angiogenic agents including bevacizumab (except for radiation necrosis protocol)
- Prior treatment with immune checkpoint inhibitors or related antibodies
- Monoclonal antibody treatment within 4 weeks before pembrolizumab start or unresolved side effects
- Chemotherapy, targeted therapy, or radiation within 2 weeks before pembrolizumab start or unresolved side effects (except mild neuropathy)
- Tumors located infratentorially, in brainstem, or less than 5 mm from certain brain structures
- Bilateral multifocal gliomas (except treatable unilateral multifocal or corpus callosal tumors)
- Leptomeningeal metastases beyond the cranial vault (some focal exceptions)
- Need for corticosteroids over 4 mg dexamethasone daily
- Recent central nervous system hemorrhage within 8 weeks (exceptions for tumor-related hemorrhage)
- Need for therapeutic anticoagulation unless safely discontinued or replaced
- Previous local therapy to planned MLA area
- Live vaccine within 30 days before treatment start
- Participation in other investigational studies within 3 weeks before treatment
- Immunodeficiency or immunosuppressive therapy within 7 days before treatment (except low-dose dexamethasone)
- Uncontrolled medical illnesses or psychiatric conditions limiting compliance
- Recent active autoimmune disease requiring systemic treatment within 2 years (some exceptions)
- Recent pneumonitis requiring steroids within 3 years or current pneumonitis (some exceptions)
- Pregnant or breastfeeding
- Known active hepatitis B or C infection
- Known active tuberculosis
- Known HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UF Health Shands Hospital
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
V
Victoria Hope
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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