Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
Recruiting now · Phase 1/Phase 2
Conditions studied: Glioblastoma Multiforme
In brief
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
Key facts
- Study ID
- NCT04977375
- Run by
- Chirag G. Patil
- People needed
- 10
- Starts
- 2021-12-09
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-09-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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