Single-center phase 2 trial of neoadjuvant nivolumab and nab-paclitaxel followed by postsurgical nivolumab for muscle-invasive bladder cancer

The phase 2 NURE-Combo trial, at San Raffaele Hospital (Milan, Italy), evaluated neoadjuvant nivolumab plus nab-paclitaxel followed by radical cystectomy (RC) and adjuvant nivolumab for patients with muscle-invasive bladder cancer MIBC). Grade 3 or 4 treatment-related adverse events occurred in 25.8% of patients. The trial met its primary endpoint, with pathologic complete response in 32.3% of patients (95% CI 16.7-51.4). An ypT≤1N0-x response was seen in 70.9% (95% CI 55-87). The 12-months event-free survival rate was 89.8% (95% CI 79.5-100). The authors conclude that the NURE-Combo combination could expand the therapeutic opportunities in patients with MIBC.