RecruitingPhase 1Phase 2NCT04977375

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

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


Sponsor

Chirag G. Patil

Enrollment

10 participants

Start Date

Dec 9, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (pembrolizumab, which helps the immune system attack cancer) alongside focused radiation therapy can improve outcomes for people with recurrent glioblastoma — a very aggressive form of brain cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with WHO Grade IV glioblastoma (GBM) - Your tumor has come back or grown after treatment, and you are planned for surgery and repeat radiation - Your tumor is smaller than 6 cm - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - You cannot have additional radiation therapy - You have previously received anti-PD-1 or similar immunotherapy - You have an immune system disorder or are on long-term steroids (more than 10 mg prednisone daily) - You have a severe allergy to pembrolizumab Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

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

RADIATIONStereotactic Radiation Therapy

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

PROCEDURESurgical Resection

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


Locations(1)

Cedars-Sinai Medical Center

Los Angeles, California, United States

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NCT04977375


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