Overview

Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma

Status:
Not yet recruiting
Trial end date:
2024-07-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chirag G. Patil
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Pembrolizumab
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.