Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma

Trial ID: NCT04977375

Interventional - Phase 1/2 - Recruiting

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

Conditions

• Glioblastoma Multiforme

Interventions

• Pembrolizumab
• Stereotactic Radiation Therapy
• Surgical Resection

Eligibility

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.

Sponsor

Chirag G. Patil, Merck Sharp & Dohme LLC, National Cancer Institute (NCI)

Source: ClinicalTrials.gov

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