Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160206
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-11-29
Brief Title:
Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma
Sponsor:
Academic and Community Cancer Research United
Organization:
Academic and Community Cancer Research United
Study Overview
Official Title:
A Phase II Open Label Randomized Study Testing the Efficacy of Retifanlimab in Combination with Bevacizumab and Hypofractionated Radiotherapy in Patients with Recurrent GBM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 bodys 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
Detailed Description:
PRIMARY OBJECTIVE
I To investigate the overall survival at 9 months OS-9 of the combination of retifanlimab bevacizumab and hypofractionated radiation therapy HFRT vs the control group treated with bevacizumab and HFRT
SECONDARY OBJECTIVES
I To assess the overall survival OS in this patient population for each regimen
II To assess the progression free survival PFS in this patient population for each regimen
III To assess the objective response rate ORR in this patient population for each regimen
IV To assess the neurologic function by Neurologic Assessment in Neuro-Oncology NANO in this patient population for each regimen
V To assess the frequency and severity of adverse events in this patient population for each regimen
CORRELATIVE OBJECTIVE
I To assess the anti-glioma immune response before and after retifanlimab including assessment of immune cells phenotyping function and activation in the pre-post-treatment blood and changes in cytokine levels over time
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive retifanlimab intravenously IV over 30 minutes on day 1 and bevacizumab IV on day 1 and 15 of each cycle Treatment repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity Patients also undergo HFRT once daily QD starting in cycle 1 on day 15 for 10 treatments Patients undergo magnetic resonance imaging MRI or computed tomography CT as well as blood sample collection throughout the study
ARM B Patients receive bevacizumab IV on day 1 and 15 of each cycle Treatment repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity Patients also undergo HFRT QD starting in cycle 1 on day 15 for 10 treatments Patients undergo MRI or CT as well as blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days Survival follow-up is every 2 months for the first year and then every 6 months for up to 4 years from registration
I To investigate the overall survival at 9 months OS-9 of the combination of retifanlimab bevacizumab and hypofractionated radiation therapy HFRT vs the control group treated with bevacizumab and HFRT
SECONDARY OBJECTIVES
I To assess the overall survival OS in this patient population for each regimen
II To assess the progression free survival PFS in this patient population for each regimen
III To assess the objective response rate ORR in this patient population for each regimen
IV To assess the neurologic function by Neurologic Assessment in Neuro-Oncology NANO in this patient population for each regimen
V To assess the frequency and severity of adverse events in this patient population for each regimen
CORRELATIVE OBJECTIVE
I To assess the anti-glioma immune response before and after retifanlimab including assessment of immune cells phenotyping function and activation in the pre-post-treatment blood and changes in cytokine levels over time
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive retifanlimab intravenously IV over 30 minutes on day 1 and bevacizumab IV on day 1 and 15 of each cycle Treatment repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity Patients also undergo HFRT once daily QD starting in cycle 1 on day 15 for 10 treatments Patients undergo magnetic resonance imaging MRI or computed tomography CT as well as blood sample collection throughout the study
ARM B Patients receive bevacizumab IV on day 1 and 15 of each cycle Treatment repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity Patients also undergo HFRT QD starting in cycle 1 on day 15 for 10 treatments Patients undergo MRI or CT as well as blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days Survival follow-up is every 2 months for the first year and then every 6 months for up to 4 years from registration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-09550 | REGISTRY | None | None |
| ACCRU-NO-2301 | OTHER | None | None |
| P30CA015083 | NIH | Academic and Community Cancer Research United | httpsreporternihgovquickSearchP30CA015083 |