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Monoclonal Antibodies

Avelumab + Radiotherapy for Leptomeningeal Disease

Phase 1
Waitlist Available
Led By Peter A Forsyth, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years on the day of signing consent
Presence of malignant cells in the CSF (CSF+) OR at least 2 of the 3 following features: clinical signs and symptoms of LMD, characteristic radiographic abnormalities, and 'suspicious' CSF (Chamberlain 2017)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 11 months
Awards & highlights

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.

Who is the study for?
This trial is for adults over 18 with Leptomeningeal Disease from any cancer except leukemia. They must have had no recent surgeries, treatments, or severe reactions to monoclonal antibodies and should not be on high steroid doses. Participants need proper organ function, a life expectancy over 8 weeks, and must use effective contraception.Check my eligibility
What is being tested?
The study aims to determine a safe dose when combining Avelumab (an immunotherapy drug) with Whole Brain Radiotherapy in treating patients whose cancer has spread to the lining of the brain and spinal cord.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to immunotherapy such as fatigue, skin reactions, immune-related complications like inflammation of organs, as well as those associated with radiotherapy including hair loss, nausea, headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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I have cancer cells in my CSF or at least 2 symptoms of LMD.
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I can take care of myself but may not be able to do active work.
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It has been over 4 weeks since my brain surgery.
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My cancer diagnosis was confirmed by lab tests, but it's not leukemia.
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I have recovered from side effects of my previous treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 11 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 11 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
Safety and Dose Limiting Toxicity (DLT) measured by number of subjects with adverse events (AEs)
Secondary outcome measures
Activation Status of T Cells
Number of T Cells
Other outcome measures
Overall Survival (OS) Rate at 3 months

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Endocrine disorders
6%
General disorders and administration site conditions
6%
Cardiac disorders
6%
Nervous system disorders
6%
Investigations
6%
Gastrointestinal disorders
6%
Immune system disorders
6%
Metabolism and nutrition disorders
6%
Infections and infestations
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Avelumab and Whole Brain RadiotherapyExperimental Treatment2 Interventions
Avelumab 800 mg intravenously (IV) and 3000 centriGray units (cGy) Whole Brain Radiotherapy once every 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
541 Previous Clinical Trials
135,433 Total Patients Enrolled
PfizerIndustry Sponsor
4,565 Previous Clinical Trials
10,906,880 Total Patients Enrolled
Peter A Forsyth, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Avelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03719768 — Phase 1
Leptomeningeal Disease Research Study Groups: Avelumab and Whole Brain Radiotherapy
Leptomeningeal Disease Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT03719768 — Phase 1
Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03719768 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~3 spots leftby Apr 2025