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NCT05879120

Randomized Study of Neo-adjuvant and Adjuvant Pembrolizumab With and Without Targeted Blood Brain Barrier Opening Using Exablate MRI-guided Focused Ultrasound (Exablate MRgFUS) for Recurrent Glioblastoma

Withdrawn Phase 2 Last updated 20 November 2024
What this trial tests

Phase 2 trial testing Pembrolizumab in Recurrent Glioblastoma. Withdrawn.

Timeline
30 July 2024
Primary endpoint
2 October 2024
2 October 2024

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposetreatment
Start date30 July 2024
Primary completion2 October 2024
Estimated completion2 October 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Recurrent Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To learn if the Exablate Model 4000 Type 2 ("Exablate System") with the DEFINITY® ultrasound contrast agent can temporarily disrupt the blood brain barrier in patients with recurrent (has grown back) glioblastoma who are scheduled to receive pembrolizumab.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Focused ultrasound-mediated enhancement of blood-brain barrier permeability for brain tumor treatment: a systematic review of clinical trials.
    Zhu H, Allwin C, Bassous MG, Pouliopoulos AN. · · 2024 · cited 34× · PMID 39207625 · DOI 10.1007/s11060-024-04795-z
  2. Immunotherapeutic Strategies for the Treatment of Glioblastoma: Current Challenges and Future Perspectives.
    Salvato I, Marchini A. · · 2024 · cited 32× · PMID 38610954 · DOI 10.3390/cancers16071276
  3. Overview of Therapeutic Ultrasound Applications and Safety Considerations: 2024 Update.
    Bader KB, Padilla F, Haworth KJ, Ellens N, et al · · 2025 · cited 23× · PMID 39526313 · DOI 10.1002/jum.16611
  4. Efficient PD-L1 imaging of murine glioblastoma with FUS-aided immunoPET by leveraging FcRn-antibody interaction.
    Chevaleyre C, Novell A, Tournier N, Dauba A, et al · · 2023 · cited 19× · PMID 37908736 · DOI 10.7150/thno.87168
  5. Device-assisted strategies for drug delivery across the blood-brain barrier to treat glioblastoma.
    Mokarram N, Case A, Hossainy NN, Lyon JG, et al · · 2025 · cited 17× · PMID 39790893 · DOI 10.1038/s43246-024-00721-y
  6. Microbubble-Enhanced Focused Ultrasound for Infiltrating Gliomas.
    Seas AA, Malla AP, Sharifai N, Winkles JA, et al · · 2024 · cited 13× · PMID 38927437 · DOI 10.3390/biomedicines12061230
  7. Chemotherapy in pediatric brain tumor and the challenge of the blood-brain barrier.
    Malik JR, Podany AT, Khan P, Shaffer CL, et al · · 2023 · cited 11× · PMID 37997517 · DOI 10.1002/cam4.6647
  8. Therapeutic manipulation and bypass of the blood-brain barrier: powerful tools in glioma treatment.
    Giantini-Larsen AM, Pandey A, Garton ALA, Rampichini M, et al · · 2025 · cited 8× · PMID 39877748 · DOI 10.1093/noajnl/vdae201

Verify or expand the search:

Other trials of Pembrolizumab

Trials testing the same drug.

Other recruiting trials for Recurrent Glioblastoma

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05879120.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing