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Avelumab + Radiotherapy for Leptomeningeal Disease
Study Summary
This trial is to find a safe dose of the combination of Avelumab and Whole Brain Radiotherapy (WBRT) for patients with Leptomeningeal Disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 19 Patients • NCT03006848Trial Design
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Who is running the clinical trial?
Media Library
- It has been over 2 weeks since my last brain radiation therapy.I am over 18 years old.I have another cancer that is getting worse or needs treatment.I have not received a live vaccine in the last 30 days.I have cancer cells in my CSF or at least 2 symptoms of LMD.I need steroids for my brain cancer symptoms.I have a serious heart condition.I can take care of myself but may not be able to do active work.My organs are functioning well.My organ functions are within normal ranges as required.My disease has worsened in the brain despite current treatment.I have lasting side effects from previous treatments, but they are not severe.I am using or willing to use effective birth control during and for 30 days after the study.I haven't had chemotherapy or targeted therapy in the last 4 weeks and have recovered from any side effects.I am currently being treated for an infection.I do not have severe health or mental health conditions that could affect my participation.It has been over 4 weeks since my brain surgery.I have an autoimmune disease treated in the last 3 months or an immunodeficiency.I cannot or do not want to have a brain MRI with contrast.I am on a low dose of steroids, less than 2 mg/day of dexamethasone or its equivalent.I have a history of HIV or hepatitis B/C.I have previously received whole brain radiation therapy.I haven't had treatments for LMD or antibody therapies in the last 4 weeks.I have lung inflammation that is not caused by an infection.I have not had major surgery or a significant injury in the last 28 days.I am not taking high doses of steroids (more than 10 mg/day).I don't have any health issues that could affect the trial's results.I have not received specific antibody treatments in the last 6 months.My cancer diagnosis was confirmed by lab tests, but it's not leukemia.I have recovered from side effects of my previous treatments.
- Group 1: Avelumab and Whole Brain Radiotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Have researchers conducted similar studies in the past?
"Avelumab is currently being trialed in 116 live studies across 1024 cities and 52 countries. The first clinical trial for Avelumab was run in 2014. The study, sponsored by EMD Serono Research & Development Institute, Inc., involved 204 patients and completed its Phase 2 drug approval stage. Since 2014 years, 47 studies have been completed."
What is the Avelumab approval status in the United States?
"Avelumab received a safety score of 1 from our analysts at Power. This is due to Avelumab being in Phase 1 clinical trials, which has limited data when it comes to the medication's efficacy and safety."
What other information is available about Avelumab?
"Avelumab is being researched in 116 different clinical trials, 10 of which are Phase 3 trials. The majority of these Avelumab trials are taking place in Barcelona and South dakota; however, there are 3692 total locations running trials for this medication."
How many test subjects are involved in this experiment?
"Unfortunately, this particular clinical trial is no longer admitting patients. Although, it was originally posted on 6/10/2019 and updated as recently as 9/30/2022. There are currently 671 other studies with open recruitment for neoplasm metastasis and 116 Avelumab trials also looking for participants."
Are we still enrolling patients for this research project?
"This particular trial, which was last updated on 9/30/2022, is no longer looking for patients. However, 787 other clinical trials are still enrolling participants."
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