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PD-L1 Inhibitor

Surgery for Meningioma

Phase 1

Waitlist Available

Led By Jiayi Huang, M.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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through time of progression (up to 6 months after completion of treatment - estimated to be 12 months)

Awards & highlights

Study Summary

This trial is testing whether combining avelumab (a PD-L1 inhibitor) with proton radiation therapy may be an effective treatment for recurrent meningioma, with the goal of increasing immunogenicity.

Eligible Conditions

Meningioma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after completion of treatment (estimated to be 12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after completion of treatment (estimated to be 12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after completion of treatment (estimated to be 12 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Immunogenicity as measured by changes of CD8+/CD4+ tumor infiltrating lymphocytes (TILs) in recurrent radiation-refractory meningioma

Secondary outcome measures

Overall survival (OS)

Pathologic response

Progression-free survival (PFS)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Avelumab + Proton TherapyExperimental Treatment3 Interventions

Avelumab will be started concurrently with proton therapy (up to 3 days before or after is permissible) and administered every 2 weeks for 3 months Proton therapy 20 CGE (cobalt gray equivalent) will be given over 5 daily fractions of 4 CGE per day during weekdays After 3 months of avelumab, patient will have a brain MRI evaluation, and radiological response will be assigned based on the iRANO criteria. Surgery will be performed as per routine clinical care If the brain MRI after 3 months of avelumab shows complete response with no signs of residual tumor, no surgery will be indicated, and the patient may continue to take adjuvant avelumab for an additional 3 months. After the patient has recovered from the surgery and if deemed medically eligible by the treating physician to receive additional immunotherapy, avelumab will be restarted and administered every 2 weeks for an additional 3 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Surgery

2000

Completed Phase 3

~2550

Avelumab

2018

Completed Phase 2

~2450

Proton Therapy

2009

Completed Phase 2

~280

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,930 Previous Clinical Trials

2,298,958 Total Patients Enrolled

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,907,861 Total Patients Enrolled

1 Trials studying Meningioma

50 Patients Enrolled for Meningioma

Jiayi Huang, M.D.Principal InvestigatorWashington University School of Medicine

6 Previous Clinical Trials

205 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Proton Therapy an accepted form of treatment according to the FDA?

"Based on the limited data collected, our team at Power deems proton therapy to be of moderate safety; thus it was scored a 1."

Answered by AI

Are there any more opportunities for individuals to enroll in this experiment?

"According to clinicaltrials.gov, the recruitment for this medical trial has already concluded with an update posted on September 27th 2022. However, there are still 157 other studies actively searching for participants as of now."

Answered by AI

Is this an innovative, groundbreaking research endeavor?

"Currently, 111 Proton Therapy clinical trials are ongoing over 1024 cities in 52 countries. The initial study was funded by EMD Serono Research & Development Institute, Inc., and involved 204 volunteers in its Phase 2 drug approval stage back in 2014; since then, 151 more studies have been conducted."

Answered by AI

What other explorations of Proton Therapy have been completed?

"At the moment, 111 clinical trials are being conducted to inquire about Proton Therapy with 10 of those in their 3rd phase. Most research for this therapy is taking place in Barcelona and South dakota; however, there are also over 3600 sites that use Proton Therapy as part of their studies."

Answered by AI

How many participants have signed up for the research trial?

"At present, no more individuals are being recruited for this trial. It was originally posted on 10th January 2018 and last edited on 27th September 2022. As an alternative, there are 46 trials that require participants with meningioma and 111 studies recruiting patients who may benefit from Proton Therapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neoadjuvant Avelumab and Hypofractionated Proton Radiation Therapy Followed by Surgery for Recurrent Radiation-refractory Meningioma

2018. "Neoadjuvant Avelumab and Hypofractionated Proton Radiation Therapy Followed by Surgery for Recurrent Radiation-refractory Meningioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03267836.