Phase IB study of Avelumab and whole brain radiotherapy in patients with leptomeningeal disease from solid tumors: Results and molecular analyses.

ABSTRACT:

Background

Leptomeningeal disease (LMD) from solid tumors has a dismal prognosis, even following treatment with anti-PD-1 therapy. We performed a phase IB study evaluating the safety of Avelumab with whole brain radiotherapy (WBRT) in LMD (NCT03719768).

Methods

Fifteen patients were enrolled with LMD from breast, lung, nasopharyngeal, ovarian, and pancreatic tumors. Patients were treated with Avelumab with WBRT, with the first infusion of Avelumab starting 14 days pre-WBRT and continuing during and post-WBRT for up to 5 cycles. Primary endpoints were safety and 3-month OS (OS3). Secondary endpoints included assessment of immune cells in the cerebrospinal fluid (CSF) using single-cell RNA-sequencing (scRNA-Seq) pre- and post-last treatment of Avelumab.

Results

DLTs occ

SUBMITTER: Pina Y 

PROVIDER: S-EPMC12916732 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature