A091401 Randomized Phase II Study of Nivolumab With or Without Ipilimumab in Patients With Metastatic or Unresectable Sarcoma
Alliance A091401 is an open-label, randomized, non-comparative, multicenter phase II study (Alliance A091401) comparing nivolumab (N) with and without ipilimumab (N+I) in patients with metastatic sarcoma. Patients were randomized to receive either N or N+I. The primary endpoint was 6-month confirmed response rate defined by RECISTv1.1. Secondary endpoints included treatment-related adverse events, progression-free survival, and overall survival.