This protocol addresses the specific clinical scenario of melanoma presenting with leptomeningeal metastasis — a distinct disease presentation evaluated in dedicated phase I/II and phase II clinical trials.
The protocol is designed for patients with melanoma who have developed leptomeningeal metastasis (LM). This population has been studied in trials enrolling patients with brain metastases progressing after local therapy, with neurological symptoms, or with confirmed leptomeningeal involvement.
The protocol involves nivolumab, which can be administered systemically. Additional routes of administration and the complete structured regimen — including all options, sequencing, and combination strategies — are available in the full protocol.
DOI: 10.1016/j.esmoop.2023.101624
Four patients with LM from melanoma were treated with systemic nivolumab in a phase II trial within a cohort of 16 patients with brain metastases progressing after local therapy, with neurological symptoms or with LM.
Intrathecal nivolumab has been explored in a phase I/II trial in patients with LM from melanoma (NCT03025256).
View source ↗