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RECRUITING
NCT04977375
PHASE1/PHASE2

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

Sponsor: Chirag G. Patil

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2021-12-09

Completion Date

2026-12

Last Updated

2025-09-03

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab

Pembrolizumab 400mg administered intravenously on Day 1, and then beginning 6 weeks post-surgery, subjects will receive 400 mg pembrolizumab every 6 weeks

RADIATION

Stereotactic Radiation Therapy

Standard of care stereotactic radiation of 24 grays over 3 days, administered beginning on Day 7

PROCEDURE

Surgical Resection

Standard of care surgical resection of tumor on Day 10-28

Locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, United States