PHASE IB STUDY OF AVELUMAB WITH RADIOTHERAPY IN PATIENTS WITH LEPTOMENINGEAL DISEASE

ABSTRACT: A phase IB, single-arm, non-randomized study to establish the safety of the PDL-1 inhibitor Avelumab with radiotherapy in patients with leptomeningeal disease (LMDz) from metastatic melanoma, lung cancer, and breast cancer. We hypothesize 1) systemic Avelumab will activate peripheral T cells and, with whole-brain radiotherapy (to induce blood-brain-barrier breakdown and stimulate antigen expression), significantly increase the number and activation status of T cells that migrate into the cerebrospinal fluid (CSF), with an Inflammatory CSF cytokine profile, in patients with LMDz; 2) this treatment regime is safe and tolerated without significant toxicities and will improve overall survival compared to historical controls; and 3) point estimates (with confidence intervals) can be derived using CSF measurements, toxicities, and clinical benefit to estimate sample sizes/schedules for an expanded Recommended Phase II Study.

ORGANISM(S): Homo sapiens

PROVIDER: GSE299082 | GEO | 2025/09/05

REPOSITORIES: GEO