Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

Brain tumor treatment is hampered by the blood-brain barrier (BBB). This barrier prevents drugs carried in the bloodstream from getting into the brain. If the BBB can be opened, making it temporarily more permeable, drugs may able to better reach the brain tumor. In this trial we will implant a novel device with 9 ultrasound emitters, allowing temporary and reversible opening of the BBB to maximize brain penetration of drugs that modulate the immune system. The device will be implanted after radiation is completed. Immune modulating drugs will be given every 3 weeks in conjunction with activat

Trial Details

NCT ID
NCT05864534
Phase
PHASE2
Sponsor
Northwestern University
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • Balstilimab
  • Botensilimab
  • Liposomal Doxorubicin
  • Sonocloud-9 (SC-9)
Locations (sample)
  • Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility Criteria

  • Have newly diagnosed pathologically proven glioblastoma, isocitric dehydrogenase-1/2 wild-type
  • Tumor with methyl guanine methyl transferase (MGMT) gene promoter unmethylated
  • Available paraffin embedded tumor tissue for the study
  • Have completed standard radiotherapy with or without temozolomide

For full eligibility, visit ClinicalTrials.gov.

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