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

Official Title

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

Summary:

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

Trial Description

Primary Outcome:

• Pathologic complete response (pCR) rate of neoadjuvant nivolumab + bempeg to Standard of Care (SOC) in all randomized participants
• Event-free survival (EFS) of neoadjuvant nivolumab + bempeg followed by adjuvant nivolumab + bempeg after RC vs. SOC

• pCR rate of neoadjuvant nivolumab monotherapy to SOC at the time of surgery in all randomized participants
• EFS of neoadjuvant nivolumab followed by adjuvant nivolumab vs. SOC
• Overall survival
• Incidence of adverse events (AEs)
• Incidence of serious adverse events (SAEs)
• Incidence of AEs leading to discontinuation
• Incidence of immune-mediated AEs (imAEs)
• Incidence of laboratory abnormalities

View this trial on ClinicalTrials.gov