Abstract
PURPOSE: Many patients with muscle-invasive bladder cancer (MIBC) are ineligible for cisplatin-based therapy. We conducted a phase II trial of neoadjuvant nivolumab ± ipilimumab for cisplatin-ineligible patients. PATIENTS AND METHODS: Patients with MIBC were enrolled in two consecutive cohorts: (i) nivolumab alone and (ii) ipilimumab/nivolumab. A third cohort with alternative dosing was planned. The primary endpoint was eligibility for cystectomy ≤60 days after last treatment. Correlative analyses were performed, with the PURE-01 trial used as an independent dataset. RESULTS: Fifteen patients enrolled onto each cohort. In cohorts 1 and 2, 12 of 15 and eight of 15 were eligible for cystectomy within 60 days, respectively. Due to cohort 2's failure to meet the primary endpoint, cohort 3 was not initiated. With nivolumab alone, four patients achieved