drugset / Trial / NCT04209114

A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer

NCT04209114

Phase 3 Completed 114 enrolled Bristol-Myers Squibb Nektar Therapeutics · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk urothelial cancer, including muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.

Timeline

Start
2020-02-05
Primary completion
2023-06-07
Completion
2023-06-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Bempegaldesleukin Protein / enzyme biologic
Subject Nivolumab Monoclonal antibody