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

What is the Purpose of this Study?

The purpose of the study is to determine whether an investigational drug called pembrolizumab combined with standard-of-care stereotactic radiation therapy and surgery is safe and effective in patients with recurrent glioblastoma. Researchers will evaluate whether the drug improves overall survival, increases the length of time during and after treatment that the patient’s cancer does not worsen, and how well the body responds to treatment. Participants will receive one dose of pembrolizumab intravenously before their planned radiation therapy and surgery. After surgery, they will receive study drug infusions every 6 weeks until disease progression, intolerable side effects, withdrawal of consent, or up to 2 years or 18 cycles of pembrolizumab, whichever comes first. Blood and tumor samples will be collected to evaluate biomarkers. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease.


Eligibility

  • * 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
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Where can I participate?

Cedars Sinai Medical Center

More about this Clinical Trial

What is the full name of this clinical trial?

IIT2019-13-PATIL-NEOPD1SRS: Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients with Recurrent Glioblastoma

Study Details
Disease Type/Condition

Brain and Nervous System

Principal Investigator

Patil, Chirag

Co-Investigators

Adam Mamelak, Amin Mirhadi, Behrooz Hakimian, Jeremy Rudnick, Jethro Hu, John Yu, Keith Black, Ray Chu, Stephen Shiao

Age Group

Adult

Phase

I/II

IRB Number

STUDY00001234

ClinicalTrials.gov ID

NCT04977375

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Brain and Nervous System

Principal Investigator

Patil, Chirag

Age Group

Adult

Phase

I/II

IRB Number

IIT2019-13-PATIL-NEOPD1SRS

ClinicalTrials.gov ID

NCT04977375

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org