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

GSE299082 Homo sapiens Expression profiling by high throughput sequencing 9 samples Submitted 2025/09/05 Platform GPL18573
Summary
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.
Published in
Phase IB study of Avelumab and whole brain radiotherapy in patients with leptomeningeal disease from solid tumors: Results and molecular analyses
Piña Y, Law V, Sahebjam S et al. · Neuro-oncology 2025 · PMID 40888040 · doi:10.1093/neuonc/noaf183
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Direct links to NCBI, no account and no request form: the whole study as GSE299082_RAW.tar, processed values as the series matrix, the supplementary file directory, and per-sample supplementary files for any of the 9 samples. Raw sequencing reads are also available from ENA.

Also filed as BioProject PRJNA1272544 and SRA study SRP590169. Searching any of these in the dataset finder brings you back here.

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