United States (several centers), Australia, Belgium, Czech Republic, Finland, Germany, Italy, Japan, Poland, Spain, Sweden
Phase II, single arm trial of nivolumab in patients with metastatic or unresectable urothelial cancer who have progressed or recurred after platinum-based chemotherapy
Nivolumab is a monoclonal antibody against PD-1 and is being evaluated in a Phase I/II in combination with ipilimumab in advanced or metastatic solid tumors including patients with urothelial cancer. It has demonstrated activity in melanoma, lung cancer, and renal cancer. This trial aims to look at the efficacy of nivolumab as a second line therapy in platinum-recurrent or -resistant urothelial tumors.
Patients were stratified in this trial based on their PD-L1 expression. Nivolumab has been approved by the FDA for patients with lung cancer and more recently for second line renal cell cancer after a comparison with everolimus revealed a clear improvement in overall survival (Checkmate 025 Phase III trial; Motzer RJ, et al. N Engl J Med. 2015: 373; 1803-13).