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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademic and Community Cancer Research United

About 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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Recurrent World Health Organization (WHO) grade IV glioblastoma. Note: Any number of recurrences are allowable. Glioblastoma (GBM) variants and molecular GBM are allowed

Candidates for radiotherapy

Prior use of bevacizumab is allowed as long as the last treatment is > 4 months prior to randomization

Disqualifiers

Pregnant persons

Nursing persons

Persons of childbearing potential who are unwilling to employ adequate contraception (men and women)

Co-morbid systemic illness or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into the study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Trial design

Treatments tested in this trial

  • Bevacizumab
  • Biospecimen Collection
  • Computed Tomography
  • Electronic Health Record Review
  • Hypofractionated Radiation Therapy
  • Magnetic Resonance Imaging
  • Retifanlimab

Treatment groups

134 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Academic and Community Cancer Research United

Lead sponsor

National Cancer Institute (NCI)

Collaborator