RecruitingPhase 2NCT06160206

Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma

A Phase II Open Label, Randomized Study Testing the Efficacy of Retifanlimab in Combination with Bevacizumab and Hypofractionated Radiotherapy in Patients with Recurrent GBM


Sponsor

Academic and Community Cancer Research United

Enrollment

134 participants

Start Date

Oct 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving retifanlimab with bevacizumab and hypofractionated radiotherapy may work better in treating patients with recurrent glioblastoma than bevacizumab and hypofractionated radiotherapy alone.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of retifanlimab (an immunotherapy drug), bevacizumab (a drug that blocks blood vessel growth in tumors), and a shorter course of radiation therapy in patients whose glioblastoma — one of the most aggressive brain tumors — has come back after prior treatment. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with recurrent glioblastoma (grade IV brain tumor) - You are a candidate for radiotherapy - You have a reasonable level of function and physical ability - Prior bevacizumab use is allowed if it was completed more than 4 months ago **You may NOT be eligible if...** - You have not previously been treated for glioblastoma - You are not a candidate for radiotherapy - Your physical condition is too poor to tolerate treatment - You require high-dose steroids that cannot be reduced 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

BIOLOGICALBevacizumab

Given IV

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT

OTHERElectronic Health Record Review

Ancillary studies

RADIATIONHypofractionated Radiation Therapy

Undergo radiation therapy

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALRetifanlimab

Given IV


Locations(3)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT06160206


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