A Multicenter Phase II Trial of Ipilimumab and Nivolumab in Unresectable or Metastatic Metaplastic Breast Cancer: Cohort 36 of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART, SWOG S1609).
Sylvia AdamsMegan OthusSandip Pravin PatelKathy D MillerRashmi ChughScott M SchuetzeMary D ChamberlinBarbara J HaleyAnna Maria V StornioloMridula P ReddyScott A AndersonCollin T ZimmermanAnne P O'DeaHamid R MirshahidiJordi Rodon AhnertFrank J BresciaOlwen HahnJane M RaymondDavid D BiggsRoisin M ConnollyElad SharonLarissa A KordeRobert C GrayEdward MayersonMelissa PletsCharles D BlankeYoung Kwang ChaeRazelle KurzrockPublished in: Clinical cancer research : an official journal of the American Association for Cancer Research (2021)
The ipilimumab and nivolumab combination showed no new safety signals and met its primary endpoint with 18% ORR in advanced, chemotherapy-refractory MpBC. All responses are ongoing at >2 to almost 3 years later. The effect of ipilimumab and nivolumab was associated with exceptional responses in a subset of patients versus no activity. This combination warrants further investigation in MpBC, with special attention to understanding mechanism of action, and carefully designed to weigh against the significant risks of irAEs.