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

A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus Bempegaldesleukin (NKTR-214), Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer
• Bladder Tumor
• Muscle-Invasive Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Specified dose on specified days
PROCEDURE	Radical cystectomy (RC)	Surgical removal of the bladder
BIOLOGICAL	Bempegaldesleukin	Specified dose on specified days

Timeline

• Start date: 2020-02-05
• Primary completion: 2023-06-07
• Completion: 2023-06-07
• First posted: 2019-12-23
• Last updated: 2024-06-27
• Results posted: 2024-06-27

Locations

116 sites across 20 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Israel, Italy, Mexico, Netherlands, Poland, Russia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study