Melanoma Clinical Trials & Research | Memorial Sloan Kettering Cancer Center
The trial at UVA Health tests whether focused ultrasound combined with immunotherapy can improve safety and efficacy in patients with advanced melanoma.
This phase I study evaluated the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the oral PKC inhibitor LXS196 in 68 patients with metastatic uveal melanoma (MUM). LXS196 was administered once daily (QD) at 100–1000 mg (n = 38) or twice daily (BID) at 200–400 mg (n = 30) until disease progression or unacceptable toxicity. Dose‑limiting toxicities (DLTs) were observed in 18.4 % of QD and 11.8 % of BID patients, most commonly hypotension. One‑year overall survival was 43 %. Clinical activity was observed in 6 of 66 evaluable patients (9.1 %) achieving partial or complete response, with a median duration of response of 10.1 months. At 300 mg BID, the recommended dose for expansion (RDE), 2 of 18 evaluable patients achieved partial response and 12 achieved stable disease. These results suggest manageable toxicity and encouraging clinical activity of single‑agent LXS196 in patients with MUM.
Focused ultrasound may activate the immune system and enhance the systemic response to PD‑1 blockade, potentially improving outcomes in advanced melanoma.
Bizonyítékszint: Klinikai vizsgálat. Formális klinikai vizsgálati eredmény.
Kapcsolódó jelek
- Beyond the Five-Year Milestone: Long‑term Survivorship of Melanoma Patients Treated Off‑Trial with anti‑PD‑1
- Uveal Melanoma – Trials in Disease – Overview of Information and Clinical Research
- A phase 1/2 trial of an immune-modulatory vaccine against IDO/PD-L1 in combination with nivolumab in metastatic melanoma
- Melanoma Research
- The Clinical Trial Landscape for Melanoma Therapies