NCT04977375PHASE1, PHASE2Recruiting
Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
Chirag G. Patil
Start Date
12/9/2021
Completion Date
12/1/2026
Summary
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
Age Range: 18 years to No maximum
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.
Interventions
DRUG
Pembrolizumab
RADIATION
Stereotactic Radiation Therapy
PROCEDURE
Surgical Resection
Conditions
Glioblastoma Multiforme
Locations
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States