Study on Retifanlimab with Bevacizumab and Radiation Therapy for Treating Recurrent Glioblastoma

Sponsor: Academic and Community Cancer Research United

Sponsor score: 0

ClinicalTrials ID:NCT06160206

This clinical trial is exploring whether adding the drug retifanlimab to the standard treatment of bevacizumab and radiation therapy can better treat glioblastoma that has returned after initial improvement.

Patient Parameters

Parameter	Options

Program Overview

The study aims to find out if combining retifanlimab, a type of immunotherapy, with bevacizumab and a special type of radiation therapy can more effectively treat glioblastoma that has come back. Retifanlimab may help the immune system attack cancer cells, while bevacizumab works by stopping the growth of blood vessels that feed tumors. The radiation therapy used in this study delivers higher doses over a shorter time, which might kill more cancer cells with fewer side effects. Researchers want to see if this combination works better than using bevacizumab and radiation therapy alone.

Description

The main goal of this study is to see if the combination of retifanlimab, bevacizumab, and radiation therapy can help patients with recurrent glioblastoma live longer. Researchers will also look at how long patients live without the cancer getting worse, how well the cancer responds to treatment, and any side effects. The study will also examine how the treatment affects patients' brain function and immune response.

Participants will be randomly assigned to one of two groups:

Group A: Will receive retifanlimab and bevacizumab through an IV, along with radiation therapy. This treatment cycle repeats every 28 days for up to 2 years, as long as the cancer does not progress and side effects are manageable. Radiation therapy will start on day 15 of the first cycle and continue for 10 sessions. Patients will have regular MRI or CT scans and blood tests.
Group B: Will receive bevacizumab through an IV, along with radiation therapy. This treatment cycle also repeats every 28 days for up to 2 years, under the same conditions as Group A. Radiation therapy will follow the same schedule as in Group A. Patients will also have regular MRI or CT scans and blood tests.

After finishing the study treatment, patients will have a follow-up visit after 30 days. Their survival will be monitored every 2 months for the first year, and then every 6 months for up to 4 years.

Eligibility Criteria

Inclusion Criteria

Must be 18 years or older.
Have recurrent glioblastoma, a type of brain cancer, confirmed by medical tests.
Eligible for radiation therapy.
Previous use of bevacizumab is allowed if it was more than 4 months ago.
Taking a low dose of dexamethasone (4mg or less daily) at the start of the study.
Have a Karnofsky performance status of 60% or higher, indicating the ability to care for oneself with some assistance.
Have measurable or non-measurable disease according to specific medical criteria.
Meet specific blood count and organ function requirements based on recent tests.
Women of childbearing potential must have a negative pregnancy test before starting the study.
Willing to provide written consent and comply with study requirements, including follow-up visits and blood sample collection.

Exclusion Criteria

Pregnant or nursing individuals, or those not using effective birth control.
Have other serious health conditions that could interfere with the study.
Currently receiving other investigational treatments for cancer.
Have uncontrolled autoimmune diseases or are on systemic treatment for such conditions.
Have severe medical conditions that could increase risks or interfere with the study.
Have allergies to similar drugs used in the study.
Have had an organ transplant.
Have uncontrolled HIV or active hepatitis B or C infections.
Have received a live vaccine within 30 days before starting the study.

Locations

FACILITY	ZIP	CITY	STATE
Mayo Clinic in Arizona	85259	Scottsdale	Arizona
Mayo Clinic in Florida	32224	Jacksonville	Florida
Mayo Clinic	55905	Rochester	Minnesota

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