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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)
Must not have
Known additional malignancy that is progressing or requires active treatment
Symptomatic brain metastases requiring steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 11 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have another cancer that is getting worse or needs treatment.
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I need steroids for my brain cancer symptoms.
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I have a serious heart condition.
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I haven't had chemotherapy or targeted therapy in the last 4 weeks and have recovered from any side effects.
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I am currently being treated for an infection.
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I have an autoimmune disease treated in the last 3 months or an immunodeficiency.
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I cannot or do not want to have a brain MRI with contrast.
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I have a history of HIV or hepatitis B/C.
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I have previously received whole brain radiation therapy.
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I have lung inflammation that is not caused by an infection.
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I have not had major surgery or a significant injury in the last 28 days.
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I am not taking high doses of steroids (more than 10 mg/day).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Dose Limiting Toxicity (DLT) measured by number of subjects with adverse events (AEs)
Secondary study objectives
Activation Status of T Cells
Number of T Cells
Other study objectives
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%
Metabolism and nutrition disorders
6%
Nervous system disorders
6%
Investigations
6%
Cardiac disorders
6%
Gastrointestinal disorders
6%
Infections and infestations
6%
Immune system disorders
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2017
Completed Phase 2
~2440

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
562 Previous Clinical Trials
144,832 Total Patients Enrolled
PfizerIndustry Sponsor
4,658 Previous Clinical Trials
17,877,267 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
~2 spots leftby Nov 2025
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