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Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
Who can join
Ages 18 and older · All sexes
Full 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.
About the study
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
What is being tested
- Pembrolizumab (drug)
- Stereotactic Radiation Therapy (radiation)
- Surgical Resection (procedure)
Sponsor: Chirag G. Patil · Participants: 10 · Started: Dec 9, 2021
Contact the study team
- Clinical Trial Recruitment Navigator · Phone: 310-423-5842
Official record on ClinicalTrials.gov — NCT04977375
Locations in the U.S.
| California | Cedars-Sinai Medical Center, Los Angeles |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.