Actively Recruiting
A Phase II Randomized Study of Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for Recurrent Glioblastoma
Led by Academic and Community Cancer Research United · Updated on 2024-11-19
134
Participants Needed
3
Research Sites
208 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
Researchers are evaluating the effects of combining retifanlimab with bevacizumab and hypofractionated radiation therapy (HFRT) compared to bevacizumab and HFRT alone in patients with recurrent glioblastoma, a type of aggressive brain tumor that has returned after prior improvement. This phase II trial aims to assess overall survival at 9 months and other outcomes such as progression-free survival, objective response rate, neurological function, and treatment side effects. The study also investigates immune responses related to retifanlimab treatment. Participants are randomly assigned to one of two groups. One group receives retifanlimab intravenously on day 1 and bevacizumab intravenously on days 1 and 15 of each 28-day cycle, plus daily HFRT starting on day 15 for 10 treatments. The other group receives bevacizumab on the same schedule and identical HFRT. Treatment may continue for up to 2 years if there is no disease progression or unacceptable side effects. Throughout the study, participants undergo MRI or CT scans and blood sample collections. After completing treatment, participants have a follow-up visit at 30 days. Survival is monitored every 2 months for the first year and then every 6 months for up to 4 years from registration. Researchers measure survival times, tumor progression, neurological function, response rates, and adverse events. They also examine immune system changes before and after treatment. The total participation duration can last several years depending on survival and follow-up.
CONDITIONS
Brief 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 grade IV glioblastoma, including variants and molecular GBM
- Candidate for radiotherapy
- Prior bevacizumab allowed if last dose was more than 4 months before enrollment
- Dexamethasone dose 4 mg daily or less at time of enrollment
- Karnofsky performance status of 60% or higher
- Measurable or non-measurable disease per Response Assessment in Neuro-Oncology criteria
- Absolute neutrophil count 1,500/mm^3 or higher within 28 days prior to registration
- Platelet count 100,000/mm^3 or higher within 28 days prior to registration
- Hemoglobin 9.0 g/dL or higher within 28 days prior to registration
- Total bilirubin 1.5 times upper limit of normal or less within 28 days prior to registration
- ALT and AST 3 times upper limit of normal or less (5 times if liver involvement) within 28 days prior to registration
- Creatinine 1.5 times upper limit of normal or less within 28 days prior to registration
- Negative pregnancy test within 14 days prior to registration for women of childbearing potential
- Able to provide informed written consent within 28 days prior to registration
- Willing to return for follow-up during active treatment
- Willing to provide mandatory blood samples for research
You will not qualify if you...
- Pregnant or nursing persons
- Persons of childbearing potential unwilling to use adequate contraception
- Severe concurrent disease making study participation unsafe or assessment unreliable
- Use of other investigational agents within 2 weeks prior to registration
- Active uncontrolled autoimmune disease requiring systemic treatment in past 2 years or current systemic therapy, except certain stable conditions
- Severe acute or chronic medical conditions increasing risk or interfering with study
- History of allergic reactions to study agents or similar compounds
- Previous allogeneic tissue or solid organ transplant
- Uncontrolled HIV infection
- Uncontrolled active hepatitis B or C infection
- Receipt of live attenuated vaccine within 30 days before first study dose, except killed virus influenza vaccines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive treatment with retifanlimab and bevacizumab with hypofractionated radiation therapy or bevacizumab with hypofractionated radiation therapy. Treatment cycles repeat every 28 days for up to 2 years unless disease progresses or unacceptable side effects occur. Radiation therapy is given once daily for 10 treatments starting on day 15 of the first cycle. Participants undergo MRI or CT scans and blood sample collection throughout treatment.
IV treatments on days 1 and 15 of each 28-day cycle; radiation therapy daily for 10 days starting day 15 of cycle 1; imaging and blood draws throughout treatment
Duration - Up to 4 years
After completing treatment, participants have a follow-up visit at 30 days. Survival is monitored every 2 months for the first year and then every 6 months for up to 4 years from registration.
1 visit at 30 days post-treatment, then visits every 2 months for 1 year, followed by visits every 6 months for up to 4 years
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
M
Mayo Clinic Cancer Studies
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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