At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 114 enrolled
Drug / intervention
Nivolumab +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Nivolumab, Radical cystectomy (RC), and 1 other intervention for Bladder Cancer and 2 related conditions. Completed, enrolled 114 participants across 116 sites in 20 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Israel, Italy, Mexico, Netherlands, Poland, Russia, Spain, United Kingdom, United States
CollaboratorsNektar Therapeutics
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 2019
Enrollment StartFeb 2020
Primary CompletionJun 2023
TodayJul 2026
First PostedDec 23, 2019
Enrollment StartFeb 5, 2020
Primary CompletionJun 7, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.5 years ago
Interventions
Nivolumabbiological
Specified dose on specified days
Radical cystectomy (RC)procedure
Surgical removal of the bladder
Bempegaldesleukinbiological
Specified dose on specified days