← Back to Search
Monoclonal Antibodies
Retifanlimab + Bevacizumab + Radiation for Recurrent Glioblastoma
Scottsdale, AZ
Phase 2
Recruiting
Led By Jian L Campian
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Age ≥ 18 years
Must not have
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 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 months after registration
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if retifanlimab + bevacizumab + radiation can improve treatment of recurrent glioblastoma. Protein and drugs may help immune system fight cancer & stop blood vessels supplying tumor.
See full description
Who is the study for?
Adults over 18 with recurrent grade IV glioblastoma, who are candidates for radiotherapy and have a Karnofsky performance status of at least 60%. They must have adequate blood counts, organ function, and controlled steroid use. Pregnant or nursing individuals and those not using contraception are excluded. People with severe diseases or conditions that could interfere with the trial or pose risks are also ineligible.Check my eligibility
What is being tested?
The trial is testing retifanlimab combined with bevacizumab and hypofractionated radiotherapy versus just bevacizumab and hypofractionated radiotherapy in treating recurrent glioblastoma. Retifanlimab is an immunotherapy drug that may help the immune system fight cancer; bevacizumab aims to stop tumor growth by inhibiting blood vessel formation.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions from receiving drugs through a vein, fatigue, issues affecting digestion like nausea or diarrhea, changes in blood cell counts leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman capable of becoming pregnant.
show original
Select...
I am 18 years old or older.
show original
Select...
I can care for myself but may not be able to do active work.
show original
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had allergic reactions to medications similar to those used in this study.
show original
Select...
I have active hepatitis B or C that is not under control.
show original
Select...
I have not received any live vaccines in the last 30 days.
show original
Select...
I have received a transplant from another person.
show original
Select...
I am not willing to use birth control.
show original
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 months after registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 months after registration
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall survival (OS)
Secondary study objectives
Incidence of adverse events
Neurologic function domain scores
OS
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (Bevacizumab and radiation)Experimental Treatment6 Interventions
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.
Group II: Arm A (Retifanlimab, bevacizumab and HFRT)Experimental Treatment7 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540
Computed Tomography
2017
Completed Phase 2
~2440
Hypofractionated Radiation Therapy
2016
Completed Phase 3
~160
Magnetic Resonance Imaging
2020
Completed Phase 3
~1180
Retifanlimab
2018
Completed Phase 2
~430
Biospecimen Collection
2004
Completed Phase 3
~1810
Find a Location
Closest Location:Mayo Clinic in Arizona· Scottsdale, AZ
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
14,072 Previous Clinical Trials
41,180,518 Total Patients Enrolled
332 Trials studying Glioblastoma
23,128 Patients Enrolled for Glioblastoma
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
4,807 Total Patients Enrolled
Jian L CampianPrincipal InvestigatorAcademic and Community Cancer Research United
1 Previous Clinical Trials
44 Total Patients Enrolled
1 Trials studying Glioblastoma
44 Patients Enrolled for Glioblastoma