Angiogenesis Inhibitor

Retifanlimab for Brain Tumor

Mayo Clinic, Phoenix, AZ

Targeting 2 different conditionsRetifanlimab +4 morePhase 2Waitlist AvailableLed 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

Disease must have recurred, and patient must be a candidate for re-irradiation and bevacizumab. Any number of recurrences are allowed

Other GBM variants and 'secondary GBM' are allowed. All grade 4 gliomas that have relapsed more than once may be included, as the prognosis of multiply recurrent grade 4 glioma patients may not differ based on IDH mutation status

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upthrough 2 years after completion of treatment (estimated to be 4 years)

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Brain Tumor
Glioblastoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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Your disease has come back, and you can be treated again with radiation therapy and bevacizumab. It doesn't matter how many times your disease has come back.

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People with different types of brain tumors called GBM, including those that have come back multiple times, can participate. It doesn't matter if they have a specific gene mutation because it doesn't affect their chances of getting better.

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You are able to perform normal daily activities with at least 60% of your usual energy and ability.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 2 years after completion of treatment (estimated to be 4 years) for reporting.

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

Awards & 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: 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation therapy

2013

Completed Phase 3

~2880

Retifanlimab

2018

Completed Phase 2

~320

Bevacizumab

FDA approved

Peripheral blood draw

2017

Completed Phase 2

~60

Epacadostat

Not yet FDA approved

0 / 3Eligibility criteria met

Find a site

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,887 Previous Clinical Trials

2,280,135 Total Patients Enrolled

Incyte CorporationIndustry Sponsor

344 Previous Clinical Trials

50,271 Total Patients Enrolled

Jian L Campian, M.D., Ph.D.Principal Investigator

Washington University School of Medicine

Milan Chheda, M.D.Principal Investigator

Washington University School of Medicine

3 Previous Clinical Trials

149 Total Patients Enrolled

Media Library

Bevacizumab (Angiogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03532295 — Phase 2

Brain Tumor Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT03532295 — Phase 2

Bevacizumab (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03532295 — Phase 2

Brain Tumor Research Study Groups: Regimen A: Retifanlimab+RT+bevacizumab, Regimen B: Retifanlimab+RT+bevacizumab+epacadostat

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

Recent research and studies

clinicaltrials.govStudy

Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas

2020. "Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03532295.