Retifanlimab + Bevacizumab + Radiation for Recurrent Glioblastoma
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on certain investigational agents or treatments for autoimmune diseases, you may need to stop them before joining the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Retifanlimab + Bevacizumab + Radiation for Recurrent Glioblastoma?
Research suggests that combining bevacizumab (a drug that blocks blood vessel growth) with radiation can improve survival in patients with recurrent glioblastoma, a type of brain cancer. Bevacizumab has been approved for use in recurrent glioblastoma and has shown promise when used with radiation therapy.12345
Is the combination of Retifanlimab, Bevacizumab, and Radiation generally safe for humans?
Bevacizumab, when used with radiation and other treatments, has been linked to side effects like stroke, bleeding, and wound-healing issues, especially in brain tumors. However, studies show it is generally feasible and safe when combined with radiation for recurrent high-grade gliomas, though some expected side effects may occur.36789
What makes the drug combination of Retifanlimab, Bevacizumab, and Radiation unique for treating recurrent glioblastoma?
This treatment is unique because it combines Retifanlimab, an immune checkpoint inhibitor that helps the immune system attack cancer cells, with Bevacizumab, which prevents the growth of blood vessels that supply tumors, and radiation therapy, which directly targets and kills cancer cells. This multi-faceted approach aims to enhance the effectiveness of treatment for recurrent glioblastoma, a condition with limited standard treatment options.2351011
Research Team
Jian L Campian
Principal Investigator
Academic and Community Cancer Research United
Eligibility Criteria
Adults over 18 with recurrent grade IV glioblastoma, who are candidates for radiotherapy and have a Karnofsky performance status of at least 60%. They must have adequate blood counts, organ function, and controlled steroid use. Pregnant or nursing individuals and those not using contraception are excluded. People with severe diseases or conditions that could interfere with the trial or pose risks are also ineligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive retifanlimab and bevacizumab with hypofractionated radiotherapy or bevacizumab with hypofractionated radiotherapy alone. Treatment repeats every 28 days for up to 2 years.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up includes survival checks and adverse event monitoring.
Treatment Details
Interventions
- Bevacizumab
- Hypofractionated Radiation Therapy
- Retifanlimab
Retifanlimab is already approved in United States for the following indications:
- Merkel cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Academic and Community Cancer Research United
Lead Sponsor
National Cancer Institute (NCI)
Collaborator