Avelumab With Radiotherapy in Patients With Leptomeningeal Disease
NCT03719768 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2026-03-02
Summary
This study is to find a safe dose of the combination of Avelumab and Whole Brain Radiotherapy (WBRT) in patients with Leptomeningeal Disease.
Conditions
- Leptomeningeal Metastases
- Leptomeningeal Disease
Interventions
- DRUG
-
Avelumab
Patients will be given 800 mg Avelumab as a one hour intravenous infusion once every 2 weeks.
- RADIATION
-
Whole Brain Radiotherapy
Patients will be given 3000 cGy Whole Brain Radiotherapy once every 2 weeks
Sponsors & Collaborators
- collaborator INDUSTRY
-
H. Lee Moffitt Cancer Center and Research Institute
lead OTHER
Principal Investigators
-
Peter A Forsyth, MD · H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-10
- Primary Completion
- 2022-07-19
- Completion
- 2024-08-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
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