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Angiogenesis Inhibitor
Combination Therapy + Radiation for Glioblastoma
Phase 2
Waitlist Available
Led By Jian L Campian, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recurrent WHO grade 4 glioblastoma or gliosarcoma, including molecular features of glioblastoma and WHO grade 4 astrocytoma or WHO grade high grade glioma
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 2 years after completion of treatment (estimated to be 4 years)
Awards & highlights
Study Summary
This trial will test a combination of drugs and radiation therapy to treat glioblastoma. The investigators hope that this will produce a more robust anti-tumor immune response and improve overall survival.
Who is the study for?
This trial is for adults with recurrent grade 4 glioblastoma or gliosarcoma who have measurable disease, normal organ and bone marrow function, and a Karnofsky performance status ≥ 60%. Patients must not be on high doses of steroids or have active infections, uncontrolled HIV/hepatitis B/C, certain heart conditions, autoimmune diseases requiring systemic treatment in the past 2 years (except under specific conditions), or a history of allergic reactions to similar drugs.Check my eligibility
What is being tested?
The study tests combining retifanlimab with radiation therapy and bevacizumab with/without epacadostat in treating recurrent brain tumors. It aims to enhance anti-tumor immune response and improve survival by leveraging the synergy between radiation therapy and immune modulators.See study design
What are the potential side effects?
Potential side effects include inflammation in organs like the bowel or lungs (immune colitis/pneumonitis), infusion reactions from drug administration, increased risk of infection due to immune system suppression, blood clots if using anticoagulants concurrently with regimen B treatments, fatigue, digestive issues that may affect drug absorption.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain tumor is a high-grade glioblastoma or gliosarcoma.
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I am 18 years old or older.
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I can care for myself but may need occasional help.
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My cancer has come back and I can be treated again with radiation and bevacizumab.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 2 years after completion of treatment (estimated to be 4 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 2 years after completion of treatment (estimated to be 4 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
Neurologic functions as measured by the NANO scale
Progression-free survival (PFS)
Safety and toxicity of regimen as measured by adverse events experienced by participant
Trial Design
2Treatment groups
Experimental Treatment
Group I: Regimen B: Retifanlimab+RT+bevacizumab+epacadostatExperimental Treatment5 Interventions
Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
Epacadostat will be administered orally at 400 mg BID.
Treatment may continue for up to two years.
Group II: Regimen A: Retifanlimab+RT+bevacizumabExperimental Treatment4 Interventions
Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
Treatment may continue for up to two years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Retifanlimab
2018
Completed Phase 2
~320
Radiation therapy
2013
Completed Phase 3
~2850
Bevacizumab
2013
Completed Phase 4
~5280
Peripheral blood draw
2017
Completed Phase 2
~60
Epacadostat
2018
Completed Phase 3
~1080
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,658 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,114 Total Patients Enrolled
Jian L Campian, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving treatment for an autoimmune disease.My brain tumor is a high-grade glioblastoma or gliosarcoma.I have used bevacizumab temporarily for brain swelling or tissue damage.I do not have uncontrolled HIV or active hepatitis B or C.I do not have any uncontrolled illnesses, including serious heart conditions.I am taking more than 4 mg of dexamethasone daily.I have been treated with specific inhibitors before.I am not taking any medications or substances that are not allowed in regimen B.I am 18 years old or older.I can care for myself but may need occasional help.My bone marrow and organs are functioning normally.I agree to use effective birth control during the study.I have been on antibiotics for more than 14 days, with approval.I am currently pregnant or breastfeeding.I have an abnormal heart rhythm, issues with my digestive system affecting medication absorption, or recently received a live vaccine.My condition is a type of brain tumor known as GBM or its variant.My cancer has come back and I can be treated again with radiation and bevacizumab.My grade 4 brain tumor has come back more than once.I have received a transplant from another person.I do not have severe immune or psychiatric conditions.I am currently on IV antibiotics for an infection or have active tuberculosis.I have not had a brain abscess in the last 6 months.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
- Group 2: Regimen A: Retifanlimab+RT+bevacizumab
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Retifanlimab achieved governmental approval from the FDA?
"Our team has assessed the safety of Retifanlimab at a 2, as there's evidence to suggest it is safe but no data yet showing its efficacy."
Answered by AI
Are there numerous places in the city that have started this experiment?
"At present, there are 4 sites operating for this research. These include Winston-Salem, Phoenix and Rochester as well as another undisclosed location. It is beneficial to pick the closest site in order to minimise your need to travel if you decide to join the study."
Answered by AI
How many participants has this clinical trial incorporated thus far?
"48 suitable patients are needed to partake in this clinical trial. These individuals can be recruited from multiple locations, including Wake Forest Baptist Medical Center and Mayo Clinic in Phoenix."
Answered by AI
To what conditions is Retifanlimab regularly employed for therapeutic purposes?
"Retifanlimab is a viable therapeutic option for patients suffering from recurrent platinum-sensitive primary peritoneal cancer, stage IV epithelial ovarian cancer after initial resection, and malignant neoplasms."
Answered by AI
What other experiments have focused on Retifanlimab thus far?
"Presently, a total of 367 clinical trials are looking into the efficacy and safety of Retifanlimab. Of these experiments, 91 have advanced to Phase 3. While most research on this medication is conducted in Taibei, Taiwan, there are 17379 other sites around the world administering Retifanlimab studies."
Answered by AI
Are there any vacancies remaining in this trial?
"According to information posted on clinicaltrials.gov, this medical trial is presently seeking participants. It was initially made available for recruitment on April 20th 2020 and its details were last updated in October 13th 2022."
Answered by AI
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