The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.
This trial has completed. Results may be available via ClinicalTrials.gov or peer-reviewed publications.
Bristol-Myers Squibb (BMY) is the sponsoring company for this trial. BiotechSign currently grades this company C (51/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.