Study on the Safety and Feasibility of Combining Optune GIO®, Laser Surgery, and Pembrolizumab for Recurrent Glioblastoma

Sponsor: University of Florida

Sponsor score: 60

ClinicalTrials ID:NCT06558214

Provider View

This clinical trial is exploring a new treatment approach for adults with recurrent or worsening glioblastoma, a type of brain cancer. The study will test the safety and practicality of using a combination of Optune GIO®, laser surgery, and the drug pembrolizumab.

Patient Parameters

Program Overview

The study aims to evaluate if a combination of treatments—Optune GIO®, MRI-guided laser ablation (MLA), and pembrolizumab—can be safely used in adults with recurrent or progressive glioblastoma, a severe form of brain cancer. Researchers want to see if this combination is feasible and effective in managing the disease.

Description

In this study, 20 adults with recurrent or worsening glioblastoma will participate. They will be divided into two groups, each with 10 patients, to receive different sequences of the treatment combination.

  • Group 1: Patients will start with Optune GIO® for 3-7 days, then undergo laser surgery (MLA) and a biopsy. After at least 10 days, they will resume Optune GIO® and start receiving pembrolizumab every three weeks.

  • Group 2: Patients will begin with Optune GIO® for 3-10 days and receive one dose of pembrolizumab before the laser surgery and biopsy. They will resume Optune GIO® and continue pembrolizumab every three weeks, starting at least one week after resuming Optune GIO®.

Patients may continue the treatment for up to two years or until the disease progresses or side effects become intolerable. Surgery to remove part of the tumor is optional and will be decided by the neurosurgeon based on safety.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with recurrent or worsening glioblastoma or astrocytoma, WHO Grade IV.
  • Clear evidence of tumor growth on a brain MRI scan.
  • At least 12 weeks since completing radiation therapy, unless there is clear evidence of tumor recurrence.
  • Good overall health with a performance status of 60% or higher.
  • Suitable for laser surgery based on tumor characteristics.
  • Eligible for Optune GIO® and pembrolizumab treatments.
  • Adequate blood and organ function as shown by specific lab tests.
  • Women of childbearing age must use effective birth control during the study and for 24 weeks after the last treatment.
  • Men with partners of childbearing potential must use birth control during the study and for 24 weeks after the last treatment.
  • Must understand and agree to the study requirements and sign a consent form.

Exclusion Criteria

  • Previous treatment with certain cancer drugs, including anti-angiogenic agents or specific immunotherapies.
  • Recent chemotherapy, targeted therapy, or radiation therapy without recovery from side effects.
  • Tumors in certain brain areas or multiple tumors that cannot be treated safely.
  • Need for high doses of steroids or recent brain bleeding.
  • Use of blood thinners unless they can be safely stopped.
  • Recent local therapy to the treatment area.
  • Recent live vaccine or participation in another clinical trial.
  • Immunodeficiency or use of immunosuppressive therapy.
  • Uncontrolled health conditions or recent severe autoimmune disease.
  • History of lung inflammation or current lung issues.
  • Pregnant or breastfeeding women.
  • Active hepatitis B or C, tuberculosis, or HIV infection.

Locations

FACILITYZIPCITYSTATE
UF Health Shands Hospital32608GainesvilleFlorida

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