Pembrolizumab and Radiation for Recurrent Glioblastoma

This study is testing a combination of pembrolizumab (an immunotherapy drug) and stereotactic radiation therapy in people with recurrent glioblastoma multiforme (a type of brain cancer). The treatment is given before standard surgery to remove the tumor. Researchers want to see if this combination is safe and well-tolerated, and if it improves how long people live. You might be able to join if you are 18 or older, have recurrent glioblastoma that can be surgically removed, and meet other health criteria. The study aims to enroll 10 participants. The current status of the study is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 10 participants.
What's involved
You would receive pembrolizumab intravenously every 6 weeks, and stereotactic radiation over 3 days. Surgical removal of the tumor would occur between Day 10 and 28.
Compensation
Not stated in the trial record.
Follow-up
Your safety and overall survival will be assessed for up to 2 years after starting treatment.

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NCT04977375

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Chirag G. Patil
~10 participants
Updated 2025-09-03 on ClinicalTrials.gov
What's tested:PembrolizumabStereotactic Radiation TherapySurgical Resection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events.
Measured over From start of study treatment until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years.
+1 more outcome measured
Glioblastoma Multiforme
1 sites across 1 states
California1
  • Chirag G Patil, MD, MS · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center
Clinical Trial Recruitment Navigator
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events.From start of study treatment until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years.

    Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events as assessed per CTCAE, Version 5.0.

  • Overall survivalFrom start of study treatment until death, loss to follow-up, or withdrawal of consent. Assessed up to 2 years.

    From start of study treatment until death, loss to follow-up, or withdrawal of consent. Subjects who are lost to survival follow-up will not be replaced, and public records may be accessed to assess Overall Survival.