A randomized, phase III study of fotemustine versus the combination of fotemustine and ipilimumab or the combination of ipilimumab and nivolumab in patients with metastatic melanoma with brain metastasis: the NIBIT-M2 trial.

Abstract

TPS9090 Background: The anti-CTLA-4 monoclonal antibody (mAb), ipilimumab (Ipi) significantly improves the survival of metastatic melanoma (MM) patients (pts). In spite of their poor prognosis, initial studies have evaluated the therapeutic potential of Ipi also in MM pts with brain metastasis (BM), providing preliminary evidences of efficacy. Among these, the multicentric, phase 2, Italian Network for Tumor Biotherapy (NIBIT)-M1 trial, combining Ipi with fotemustine, showed initial signs of activity in a subset of 20 MM subjects with active BM, regardless of prior radiotherapy. Though limited by the number of pts enrolled, disease control in the brain was long lasting achieving a 3-year survival rate of 28% (Di Giacomo et al, Annals Oncol, 2014). Based these results and on the highly promising efficacy of Ipi in combination with nivolumab (Nivo) in MM patients without BM, the NIBIT-M2 study will further explore the efficacy of immunotherapy with check-point blocking mAb in MM pts with BM. Methods: The NI...