Actively Recruiting
Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma
Led by Academic and Community Cancer Research United · Updated on 2024-11-19
134
Participants Needed
3
Research Sites
321 weeks
Total Duration
On this page
Sponsors
A
Academic and Community Cancer Research United
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of recurrent World Health Organization (WHO) grade IV glioblastoma or variants
- Suitable candidate for radiotherapy
- Prior bevacizumab allowed if last treatment was more than 4 months before enrollment
- Daily dexamethasone dose of 4 mg or less at enrollment
- Karnofsky performance status of 60% or higher
- Measurable or non-measurable disease per Response Assessment in Neuro-Oncology criteria
- Absolute neutrophil count of at least 1,500/mm3 within 28 days before enrollment
- Platelet count of at least 100,000/mm3 within 28 days before enrollment
- Hemoglobin level of at least 9.0 g/dL within 28 days before enrollment
- Total bilirubin less than or equal to 1.5 times the upper limit of normal within 28 days before enrollment
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) less than or equal to 3 times upper limit of normal, or 5 times if liver involved, within 28 days before enrollment
- Creatinine less than or equal to 1.5 times upper limit of normal within 28 days before enrollment
- Negative pregnancy test within 14 days before enrollment for women of childbearing potential
- Provided informed written consent within 28 days before enrollment
- Willing to return to the enrolling institution for follow-up during active treatment
- Willing to provide mandatory blood specimens for research
You will not qualify if you...
- Pregnant or nursing persons
- Persons of childbearing potential unwilling to use adequate contraception
- Severe systemic illness or other serious disease making participation unsafe or assessment unreliable
- Receiving other investigational treatment for primary tumor within 2 weeks before enrollment
- Active uncontrolled autoimmune disease or syndrome requiring recent systemic treatment
- Severe acute or chronic medical conditions or lab abnormalities increasing risk or interfering with study
- History of allergic reactions to retifanlimab, bevacizumab, or similar agents
- History of allogeneic tissue or solid organ transplant
- Uncontrolled HIV infection
- Active uncontrolled hepatitis B or C infection
- Receipt of live attenuated vaccine within 30 days before first study treatment; killed virus vaccines allowed except intranasal influenza vaccine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Active, Not Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Active, Not Recruiting
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
I
Inbox Mayo Clinic Cancer Studies
CONTACT
M
Mayo Clinic Cancer Studies
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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