Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Meningeal Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Avelumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Avelumab 800 mg intravenously (IV) and 3000 centriGray units (cGy) Whole Brain Radiotherapy once every 2 weeks

Patients will be given 800 mg Avelumab as a one hour intravenous infusion once every 2 weeks.

Patients will be given 3000 cGy Whole Brain Radiotherapy once every 2 weeks

Whole Brain Radiotherapy

Peter A Forsyth, MD

This study is to find a safe dose of the combination of Avelumab and Whole Brain Radiotherapy (WBRT) in patients with Leptomeningeal Disease.

Avelumab With Radiotherapy in Patients With Leptomeningeal Disease

Phase IB Study of Avelumab With Radiotherapy in Patients With Leptomeningeal Disease

OS, utilizing 95% confidence interval (95%CI).

Adverse events will only include those that are determined to be related to study drug.

A DLT will be defined as any one of the following adverse events occurring within 28 days from first dose of Avelumab. Central Nervous System (CNS) toxicities: Any grade 3 or higher central nervous adverse events, including but not limited to cerebral hemorrhage and new-onset neurologic deficit. Non-CNS toxicities: Any grade 3 or higher nonhematologic AE with the exception of alopecia and fatigue - Grade \> 3 nausea, vomiting, or diarrhea despite maximal medical therapy - Grade \> 3 laboratory value if 1)medical intervention is required to treat the patient or 2) the abnormality leads to hospitalization • Any grade 3 or 4 event that does not improve within 6 weeks

The number of T cells in the cerebrospinal fluid (CSF) and the CSF cytokine activation profile in the CSF (relative to serum) measured before and after Avelumab administration.

The activation status of T cells in the cerebrospinal fluid (CSF) and the CSF cytokine activation profile in the CSF (relative to serum) measured before and after Avelumab administration.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Avelumab With Radiotherapy in Patients With Leptomeningeal Disease	NCT03719768	Leptomeningeal ... Leptomeningeal ...	Avelumab Whole Brain Rad...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Avelumab With Radiotherapy in Patients With Leptomeningeal Disease	NCT03719768	Leptomeningeal ... Leptomeningeal ...	Avelumab Whole Brain Rad...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Avelumab With Radiotherapy in Patients With Leptomeningeal Disease	NCT03719768	Leptomeningeal ... Leptomeningeal ...	Avelumab Whole Brain Rad...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for lmdz

Every month we try and update this database with for lmdz cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for lmdz

Every month we try and update this database with for lmdz cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lmdz cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.