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

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Biological
  Bevacizumab

  Given IV

• Procedure
  Biospecimen Collection

  Undergo blood sample collection

• Procedure
  Computed Tomography

  Undergo CT

• Other
  Electronic Health Record Review

  Ancillary studies

• Radiation
  Hypofractionated Radiation Therapy

  Undergo radiation therapy

• Procedure
  Magnetic Resonance Imaging

  Undergo MRI

• Biological
  Retifanlimab

Locations (3)