Multicenter phase 2 trial of nivolumab adjuvant to chemoradiation for localized muscle-invasive urothelial cancer

Muscle-invasive uothelial cancer (MIUC) has a high risk of recurrence after definitive treatment. After radical surgery, adjuvant nivolumab improves disease-free survival of MIUC patients at high risk of recurrence. Chemoradiation (CRT) can be used for patients who are not surgical candidates or elect bladder preservation. The multicenter phase 2 NEXT trial in the United States evaluated adjuvant nivolumab after CRT for stage II-IV MIUC. Failure-free survival at 2 years was 33.2% (95% CI 18.5-59.6), while a limited number of high-risk features and low cell-free DNA were prognostic of better outcomes.Nivolumab-associated adverse events were seen in 63.3% of patients (grade 3 in 10.7%). The authors conclude that adjuvant nivolumab after CRT for stage II-IV MIUC was well tolerated and possibly effective.