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New treatment option for Recurrent Glioblastoma
Official title Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT06160206
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for recurrent glioblastoma.
Also referred to as ABP 215, Anti-VEGF.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Recurrent World Health Organization (WHO) grade IV glioblastoma. Note: Any number of recurrences are allowable. Glioblastoma (GBM) variants and...
- 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)
You likely can't join if
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus...
- 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...
- Receiving any other investigational agent which would be considered treatment for the primary neoplasm ≤ 2 weeks prior to registration
See the full eligibility criteria
Who can 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%
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.