Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04977375

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

Led by Chirag G. Patil · Updated on 2025-09-03

10

Participants Needed

1

Research Sites

259 weeks

Total Duration

On this page

Sponsors

C

Chirag G. Patil

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Confirmed histologic diagnosis of WHO Grade IV, Glioblastoma Multiforme
  • Glioblastoma 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

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Research Team

C

Clinical Trial Recruitment Navigator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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