A Phase II Study to Evaluate Safety and Efficacy of Combined Treatment With Ipilimumab and Intratumoral Interleukin-2

Intratumoral injection of interleukin-2 (IL-2) into melanoma metastases is a highly efficient local treatment. Furthermore, a systemic effect is assumed based on the observation of a favorable long term outcome. However, objective responses in untreated lesions have not been observed yet. Ipilimumab seems to be efficient in a subset of treated patients by inhibition of down-regulation of tumor-specific cellular immune-responses. In the context of the proposed trial, we assume (i) that ipilimumab could potentiate systemic melanoma-specific immune responses, which are primarily induced by intratumoral IL-2 and (ii) that these immune responses become more effective with regards to not IL-2 injected distant lesions. Therefore we assume a synergistic effect with regards to efficiency by the combination.