NCT03719768

Avelumab With Radiotherapy in Patients With Leptomeningeal Disease

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-06-10
• Primary completion: 2022-07-19
• Completion: 2024-08-21
• First posted: 2018-10-25
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study