Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
Sponsor: Chirag G. Patil
ClinicalTrials ID:NCT04977375
This study evaluates the safety and feasibility of pembrolizumab and stereotactic radiation before surgical resection in recurrent glioblastoma patients. Eligible participants are adults with confirmed glioblastoma, tumor size <6 cm, and ECOG 0-1. Interventions include pembrolizumab, stereotactic radiation, and surgical resection, with assessments of survival and immune response.
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Program Overview
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
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.
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