OncoMatch/Clinical Trials/NCT06558214
OPTIMUS PRIME: Safety and Feasibility of OPTune GIO® Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa, A randomizEd Trial
Is NCT06558214 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Optune GIO® for recurrent glioblastoma.
Treatment: Pembrolizumab · Optune GIO® · NeuroBlate® — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
Required: IDH2 wild-type
Disease stage
Required: Stage WHO GRADE IV (WHO)
Grade: 4 (WHO)
WHO Grade IV, IDH wild-Type or astrocytoma WHO grade IV
Demographics
Prior therapy
Cannot have received: anti-angiogenic agent (bevacizumab)
Exception: bevacizumab radiation necrotic protocol
Prior treatment with any anti-angiogenic agent, including bevacizumab (at the exception of bevacizumab radiation necrotic protocol)
Cannot have received: anti-PD-1 therapy
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Cannot have received: monoclonal antibody
Exception: allowed if >4 weeks prior and recovered to ≤ grade 1 or baseline from adverse events
Prior treatment with a monoclonal antibody within 4 weeks prior to the projected first dose of pembrolizumab or has not recovered (i.e. ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
Cannot have received: chemotherapy
Exception: allowed if >2 weeks prior and recovered to ≤ grade 1 or baseline from adverse events; ≤ grade 2 neuropathy is an exception
Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the projected first dose of pembrolizumab or has not recovered (i.e. ≤ grade 1 or at baseline) from adverse events due to a previously administered agent. Note: patients with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.
Cannot have received: targeted small molecule therapy
Exception: allowed if >2 weeks prior and recovered to ≤ grade 1 or baseline from adverse events; ≤ grade 2 neuropathy is an exception
Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the projected first dose of pembrolizumab or has not recovered (i.e. ≤ grade 1 or at baseline) from adverse events due to a previously administered agent. Note: patients with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.
Cannot have received: radiation therapy
Exception: allowed if >2 weeks prior and recovered to ≤ grade 1 or baseline from adverse events; ≤ grade 2 neuropathy is an exception
Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the projected first dose of pembrolizumab or has not recovered (i.e. ≤ grade 1 or at baseline) from adverse events due to a previously administered agent. Note: patients with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.
Cannot have received: local therapy (stereotactic radiosurgery, brachytherapy, carmustine wafers)
Received prior local therapy (stereotactic radiosurgery, brachytherapy, or carmustine wafers) to the proposed area of MLA treatment
Lab requirements
Blood counts
ANC ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (transfusion is allowed)
Kidney function
Serum creatinine ≤ 1.5 x IULN OR creatinine clearance by Cockcroft-Gault ≥ 60 mL/min for patients with serum creatinine > 1.5 x IULN
Liver function
Serum total bilirubin ≤ 1.5 x IULN OR direct bilirubin ≤ IULN for patients with total bilirubin > 1.5 x IULN; AST (SGOT) ≤ 3 x IULN; ALT (SGPT) ≤ 3 x IULN
Adequate bone marrow and organ function as defined below: 1. ANC ≥ 1,500/mcL 2. Platelets ≥ 100,000/mcL 3. Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (transfusion is allowed) 4. Serum creatinine ≤ 1.5 x IULN OR creatinine clearance by Cockcroft-Gault ≥ 60 mL/min for patients with serum creatinine > 1.5 x IULN 5. Serum total bilirubin ≤ 1.5 x IULN OR direct bilirubin ≤ IULN for patients with total bilirubin > 1.5 x IULN 6. AST (SGOT) ≤ 3 x IULN 7. ALT (SGPT) ≤ 3 x IULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UF Health Shands Hospital · Gainesville, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06558214 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-angiogenic agent, anti-PD-1 therapy, monoclonal antibody disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 wild-type is a required biomarker for enrollment.
Does this trial require IDH2?
Yes, IDH2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage WHO GRADE IV is required.
Is there an age limit?
Yes. Patients must be 90 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages