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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
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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 11 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 11 months
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 • NCT0300684817%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Infections and infestations
6%
Investigations
6%
General disorders and administration site conditions
6%
Endocrine disorders
6%
Cardiac disorders
6%
Gastrointestinal disorders
6%
Immune system disorders
6%
Metabolism and nutrition disorders
6%
Nervous 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
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
549 Previous Clinical Trials
135,694 Total Patients Enrolled
PfizerIndustry Sponsor
4,595 Previous Clinical Trials
12,868,754 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Avelumab and Whole Brain Radiotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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