A phase 1 dose escalation trial of ipilimumab and stereotactic body radiotherapy in metastatic melanoma

We conducted a phase I trial, evaluating safety and efficacy of the ipilimumab/radiotherapy combination in metastatic melanoma. Thirteen patients were enrolled of which 12 were irradiated. The treatment proved to be feasible and safe with grade 3 or 4 ipilimumab-related adverse events occurring in 25% of patients, which is in line with expected side-effect profile of ipilimumab. Evaluation of non-irradiated lesions showed that 3 of 13 patients experienced clinical benefit.

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