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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma

Sponsor: Chirag G. Patil • ClinicalTrials.gov ID: NCT04977375

Registry updated: 2026-09-21
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Description

The purpose of this study is to assess the safety/tolerability/feasibility of pembrolizumab and radiation therapy before surgical resection in patients with recurrent glioblastoma as defined by treatment-related AEs and the number of patients who do not necessitate a delay in surgical resection, and to assess overall survival. The secondary objectives are to assess progression free survival, and to assess the T cell clonality, CD8 T cell activation and Tumor Infiltrating Lymphocyte (TIL) score after treatment

Interventions

  • Pembrolizumab (Drug)
    Pembrolizumab 400mg administered intravenously on Day 1, and then beginning 6 weeks post-surgery, subjects will receive 400 mg pembrolizumab every 6 weeks
  • Stereotactic Radiation Therapy (Radiation)
    Standard of care stereotactic radiation of 24 grays over 3 days, administered beginning on Day 7
  • Surgical Resection (Procedure)
    Standard of care surgical resection of tumor on Day 10-28

Eligibility criteria

Inclusion Criteria: * Age 18 years or older * Confirmed histologic diagnosis of WHO Grade IV, Glioblastoma Multiforme * GBM recurrence or progression with planned standard of care surgical resection and repeat radiation * Tumor size less than 6 cm * ECOG performance status of 0-1 * Adequate laboratory values Exclusion Criteria: * Contraindication to additional radiation * Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor * Immunodeficiency diagnosis or receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone) or any other form of immunosuppressive therapy * Severe hypersensitivity to pembrolizumab Complete inclusion/exclusion criteria are detailed in the protocol.

Conditions

Glioblastoma Multiforme

Locations

  • Cedars-Sinai Medical Center — Los Angeles, California, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record