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

Chirag G. Patil

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Glioblastoma Multiforme

Treatments

Procedure: Surgical Resection

Radiation: Stereotactic Radiation Therapy

Drug: Pembrolizumab

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT04977375

R21CA256421 (U.S. NIH Grant/Contract)

IIT2019-13-Patil-NeoPD1SRS

Details and patient eligibility

About

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

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.