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Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment closed, study ongoing Show 4 more changesShow less
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Site details revised
    • Publications: details revised at 7 of 7 entries
  2. Re-verified, no change to tracked fieldsv13
  3. Primary completion pushed from May 2026 to Jul 31, 2031
    • Study completion pushed from Aug 2026 to Aug 31, 2031
    v12
  4. Start date: Jan 31, 2024 to Jan 19, 2024v11
  5. Site contact updatedv10
Show 8 earlier versionsHide 8 earlier versions
  1. Study Identification, Study Status, Conditionsv9
  2. Site contact updatedv8
  3. Start date changed from estimate of Mar 1, 2024 to Jan 31, 2024v7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v6
  5. Lead sponsor: [Redacted] to Northwestern Universityv5 Show 6 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: May 2026
    • Study completion date: Aug 2026
    • Start date: Mar 1, 2024
    • Collaborators expanded, about 3 words
    • Study title shortened, about 3 words
  6. 3 versions Re-verified since May 17, 2023, no change to tracked fieldsv2-v4
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Northwestern University
387 trials monitored
See 35 trials at risk
Glioma
1,251 trials monitored
See 88 trials at risk
Glioblastoma
710 trials monitored
See 52 trials at risk
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 activation of the device to open the BBB. The objectives of this trial are to establish whether it is safe and feasible to administer immune modulating drugs in this manner, and identify whether the treatment is effective in treating glioblastoma.
Trial Details
NCT Number NCT05864534
Lead Sponsor Northwestern University
Collaborators: Agenus Inc., CarThera
Conditions
(from sponsor)		 Newly Diagnosed Glioblastoma, Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype, Gliosarcoma, Glioblastoma Multiforme
Related terms Glioblastoma, Gliosarcoma
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov