Regional treatment and modern immunotherapy for patients with uveal melanoma metastasis - an international randomized controlled multicenter trial

Uveal melanoma is a cancer arising from the uveal tract of the eye. Prognosis is poor in that patients often develop liver metastases and no effective treatments are currently available.

Our recent phase III randomized trial demonstrated the effectiveness of locoregional treatment with isolated hepatic perfusion (IHP) while our translational research suggests that this treatment can activate the immune system.

By sensitizing uveal melanoma to immunotherapy, efficacy of treatment may be further increased.The primary aim is to evaluate in a randomized controlled multicenter trial including 40 patients if the combination of percutaneous hepatic perfusion together with modern immunotherapy (ipilimumab 1mg/kg and nivolumab 3mg/kg) can improve the primary endpoint progression-free survival compared to only immunotherapy (ipilimumab 3mg/kg and nivolumab 1mg/kg).

Secondary endpoints include response rate, survival and quality of life, as well as translational endpoints with ctDNA conversion.

Patients with isolated uveal melanoma liver metastases will be included from all regions of Sweden, the trial will be recommended as the first-line treatment option for patients in Sweden, and findings will likely be incorporated immediately into clinical practice upon completion of this study.