Pembrolizumab with focused stereotactic radiation before surgery for recurrent glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2, single-center trial gives pembrolizumab (an anti-PD-1 antibody) together with stereotactic radiation prior to planned surgical resection in adults with recurrent glioblastoma. The primary goals are to test safety, tolerability, and feasibility measured by treatment-related adverse events and the number of patients who can proceed to surgery without delay, with overall survival as a key outcome. Secondary endpoints include progression-free survival and immune correlative studies such as T-cell clonality, CD8 T-cell activation, and tumor-infiltrating lymphocyte scoring. Key eligibility features include age ≥18, ECOG 0–1, tumor <6 cm, no prior anti-PD-1/PD-L1 therapy, and the ability to tolerate additional radiation; the trial is conducted at Cedars-Sinai Medical Center in Los Angeles.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Chirag G Patil, MD, MS — Cedars-Sinai Medical Center
• Study coordinator: Clinical Trial Recruitment Navigator
• Email: GroupCancerTrialInformation@cshs.org
• Phone: 310-423-5842

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.