Recurrent GlioblastomaPhase 2NCT06160206
Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma
A Phase 2 study testing Bevacizumab, Biospecimen Collection and Computed Tomography in people with Recurrent Glioblastoma and Recurrent WHO Grade 4 Glioma, run by Academic and Community Cancer Research United at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma, Recurrent WHO Grade 4 Glioma
- What is being tested?
- Bevacizumab, Biospecimen Collection and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Oct 2024to 30 Nov 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Dexamethasone dose ≤ 4mg daily at the time of randomization (higher dose of steroid for symptom control is allowed during the study)
- Karnofsky performance status ≥ 60%
Show all 27Show fewer
- Measurable disease or non-measurable disease per Response Assessment in Neuro-Oncology (RANO) criteria
- Absolute neutrophil count (ANC) ≥ 1,500/mm^3 (obtained ≤ 28 days prior to registration)
- NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the "Lab Test Unit Conversion Worksheet" available on the Academic and Community Cancer Research Untied (ACCRU) website under "General Forms"
- Platelet count ≥ 100,000/mm^3 (obtained ≤ 28 days prior to registration)
- NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the "Lab Test Unit Conversion Worksheet" available on the ACCRU website under "General Forms"
- Hemoglobin ≥ 9.0 g/dL (obtained ≤ 28 days prior to registration)
- NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the "Lab Test Unit Conversion Worksheet" available on the ACCRU website under "General Forms"
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 28 days prior to registration)
- NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the "Lab Test Unit Conversion Worksheet" available on the ACCRU website under "General Forms"
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 28 days prior to registration)
- NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the "Lab Test Unit Conversion Worksheet" available on the ACCRU website under "General Forms"
- Creatinine ≤ 1.5 x ULN (obtained ≤ 28 days prior to registration)
- NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the "Lab Test Unit Conversion Worksheet" available on the ACCRU website under "General Forms"
- Negative pregnancy test done ≤ 14 days prior to registration for women of childbearing potential only. (Pregnancy test can be urine or serum.)
- NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- A female of childbearing potential is a sexually mature female who:
- 1) Has not undergone a hysterectomy or bilateral hysterectomy; or
- 2) Has not been naturally postmenopausal for at least 12 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months)
- Provide informed written consent ≤ 28 days prior to registration
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study, i.e., active treatment)
- Willing to provide mandatory blood specimens for correlative research purposes
Who cannot join
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
- 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
- Receiving any other investigational agent which would be considered treatment for the primary neoplasm ≤ 2 weeks prior to registration
Show all 13Show fewer
- Active uncontrolled autoimmune disease or syndrome (i.e. moderate or severe rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, active inflammatory bowel disease) that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) or who are receiving systemic therapy for an autoimmune or inflammatory disease (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Subjects are permitted to enroll if they have vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
- Has a severe acute or chronic medical condition including immune colitis, inflammatory bowel disease (may be enrolled at the discretion of the principal investigator [PI]), immune pneumonitis, or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to epacadostat, retifanlimab, bevacizumab, or other agents used in the study
- Has had an allogeneic tissue/solid organ transplant
- Has uncontrolled human immunodeficiency virus (HIV) (HIV ½ antibodies). Well-controlled HIV is defined as CD4+ count > 300 cells, undetectable viral load, and receiving highly active antiretroviral therapy (HAART)/antiretroviral therapy (ART). Study specific HIV testing is not required for patients who do not have any prior history of HIV
- Has uncontrolled active hepatitis B (HBV) (e.g., hepatitis B serum antigen [HBsAg] reactive or HBV dioxyribonucleic acid [DNA] detected by quant real time polymerase chain reaction [RT PCR]) or hepatitis C (e.g. hepatitis C serum antigen [HCsAg] reactive or hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative or quantitative] is detected)
- Receipt of live attenuated vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Active, not recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Jian L. Campian, Campian.Jian@mayo.edu
Jian L. Campian
- Active, not recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- To assess the frequency and severity of adverse events in this patient population for each regimen.
CORRELATIVE OBJECTIVE:
- 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.
- Being tested
- Bevacizumab, Biospecimen Collection, Computed Tomography, Electronic Health Record Review, Hypofractionated Radiation Therapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabBiological
Also called ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04
Given IV
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Electronic Health Record ReviewOther
Ancillary studies
Hypofractionated Radiation TherapyRadiation
Also called Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated
Undergo radiation therapy
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Undergo MRI
RetifanlimabBiological
Also called INCMGA 0012, INCMGA-0012, INCMGA00012, INCMGA0012
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Retifanlimab, bevacizumab and HFRT) | Experimental | ARM I: Patients receive retifanlimab 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 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. Receives: Biological: Bevacizumab; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Electronic Health Record Review; Radiation: Hypofractionated Radiation Therapy; Procedure: Magnetic Resonance Imaging; Biological: Retifanlimab |
| Arm B (Bevacizumab and radiation) | Experimental | 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. Receives: Biological: Bevacizumab; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Electronic Health Record Review; Radiation: Hypofractionated Radiation Therapy; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Defined as the proportion of patients who are alive 9 months after randomization based on Kaplan Meier estimate. The proportion of patients alive will be compared between treatment arms using a z-score test statistic. The 9-month OS Kaplan Meier estimate and corresponding 95% confidence interval for each arm will be reported.
Measured: Time until death from any cause, assessed up to 9 months after registration
Secondary outcomes (5)
OS
Overall survival is defined as the time from registration to death from any cause. OS will be estimated using the Kaplan-Meier method. The logrank test will be used to compare the distribution between treatment arms. The median OS and corresponding 95% confidence interval (by Brookmeyer and Crowley) will be reported for each treatment arm.
Measured: Up to 4 years after registration
Progression free survival (PFS)
Progression free survival is defined as the time from randomization to documentation of disease progression or death due to any cause, whichever is first. The distribution of PFS will be estimated using the method of Kaplan-Meier. PFS will be compared between the 2 treatment arms using the log-rank test. The median PFS and corresponding 95% confidence intervals will be reported.
Measured: Up to 4 years after registration
Objective response rate (ORR)
Objective response is defined as experiencing a complete response (CR) or partial response (PR) (as defined by RANO criteria, see section 11.0) while on protocol treatment. Objective response rate (ORR) is defined as the number of patients who experience objective response divided by the number of patients in the primary analysis population. ORR will be compared between the 2 treatment arms. Confidence intervals for ORR will be calculated according to the approach of Clopper and Pearson. Overall response rate and the corresponding 95% confidence interval will be reported.
Measured: Up to 4 years after registration
Neurologic function domain scores
Neurologic function domain scores of the Neurologic Assessment in Neuro-Oncology be summarized by descriptive statistics including mean, median, standard deviation, and range for each regimen at each time point. The difference between baseline and 2 months (1st restaging scan) will be compared using a Wilcoxon Rank Sum test across arm for each domain. The median difference for each domain and 1st and 3rd quartile will be reported for each arm.
Measured: Up to 2 months after registration
Incidence of adverse events
The overall adverse event rates for grade 3 or higher adverse events will be reported.
Measured: Up to 4 years after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start2 Oct 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academic and Community Cancer Research United
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jian L Campian, Principal investigator, Academic and Community Cancer Research United
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160206
- Sponsor's protocol ID
- ACCRU-NO-2301
- Other IDs
- NCI-2023-09550, ACCRU-NO-2301, P30CA015083
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06160206
- Acronym / sponsor ID
- ACCRU-NO-2301
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Academic and Community Cancer Research UnitedUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- To assess the frequency and severity of adverse events in this patient population for each regimen.
CORRELATIVE OBJECTIVE:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Retifanlimab, bevacizumab and HFRT) | Experimental | Biological: Bevacizumab, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Other: Electronic Health Record Review, Radiation: Hypofractionated Radiation Therapy, Procedure: Magnetic Resonance Imaging, Biological: RetifanlimabARM I: Patients receive retifanlimab 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 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. |
| Arm B (Bevacizumab and radiation) | Experimental | Biological: Bevacizumab, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Other: Electronic Health Record Review, Radiation: Hypofractionated Radiation Therapy, Procedure: Magnetic Resonance ImagingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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
- Dexamethasone dose ≤ 4mg daily at the time of randomization (higher dose of steroid for symptom control is allowed during the study)
Key exclusion criteria (13 listed)
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
- 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
- Receiving any other investigational agent which would be considered treatment for the primary neoplasm ≤ 2 weeks prior to registration
- Active uncontrolled autoimmune disease or syndrome (i.e. moderate or severe rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, active inflammatory bowel disease) that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) or who are receiving systemic therapy for an autoimmune or inflammatory disease (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Subjects are permitted to enroll if they have vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
- Has a severe acute or chronic medical condition including immune colitis, inflammatory bowel disease (may be enrolled at the discretion of the principal investigator [PI]), immune pneumonitis, or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04Given IV | Biological | Arm A (Retifanlimab, bevacizumab and HFRT), Arm B (Bevacizumab and radiation) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm A (Retifanlimab, bevacizumab and HFRT), Arm B (Bevacizumab and radiation) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Arm A (Retifanlimab, bevacizumab and HFRT), Arm B (Bevacizumab and radiation) |
| Electronic Health Record ReviewAncillary studies | Other | Arm A (Retifanlimab, bevacizumab and HFRT), Arm B (Bevacizumab and radiation) |
| Hypofractionated Radiation TherapyAlso: Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, HypofractionatedUndergo radiation therapy | Radiation | Arm A (Retifanlimab, bevacizumab and HFRT), Arm B (Bevacizumab and radiation) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic ResonanceUndergo MRI | Procedure or surgery | Arm A (Retifanlimab, bevacizumab and HFRT), Arm B (Bevacizumab and radiation) |
| RetifanlimabAlso: INCMGA 0012, INCMGA-0012, INCMGA00012, INCMGA0012Given IV | Biological | Arm A (Retifanlimab, bevacizumab and HFRT) |
Primary outcome
Overall survival (OS)
Time frame: Time until death from any cause, assessed up to 9 months after registration
Defined as the proportion of patients who are alive 9 months after randomization based on Kaplan Meier estimate. The proportion of patients alive will be compared between treatment arms using a z-score test statistic. The 9-month OS Kaplan Meier estimate and corresponding 95% confidence interval for each arm will be reported.
5 secondary outcomes
OS
Time frame: Up to 4 years after registration
Progression free survival (PFS)
Time frame: Up to 4 years after registration
Objective response rate (ORR)
Time frame: Up to 4 years after registration
Neurologic function domain scores
Time frame: Up to 2 months after registration
Incidence of adverse events
Time frame: Up to 4 years after registration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian L Campian principal investigator
Academic and Community Cancer Research United
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, Biospecimen Collection and Computed Tomography in people with Recurrent Glioblastoma and Recurrent WHO Grade 4 Glioma, run by Academic and Community Cancer Research United at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inbox Mayo Clinic Cancer Studies (507-538-5424, MAYOCLINICCANCERSTUDIES@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Time until death from any cause, assessed up to 9 months after registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.