EU Clinical Trial 2018-002676-40

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  May 30, 2019

Main objective of the trial: - To compare the pCR rate of neoadjuvant nivolumab + NKTR-214 to Standard of Care (SOC, no neoadjuvant therapy) in all randomized participants - To compare the event-free survival (EFS) of neoadjuvant nivolumab + NKTR-214 followed by adjuvant nivolumab + NKTR-214 after radical cystectomy (RC) versus SOC (no neoadjuvant or adjuvant therapy)

Parties

Sponsors
Countries
AR AT AU BE BR CA CZ DE ES EU FR GB GR IL IT MX NL NZ PL RU US
Keywords
BMS-936558 Bladder cancer NIVOLUMAB NIVOLUMAB - 10ml vial - COMMERCIAL NKTR-214 Not yet assigned Opdivo (100 mg/10 ml)

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Source:  EMA Last updated:  Jun 5, 2019

From ClinicalTrialsRegister.eu, a database of the European Medicines Agency. This record may not reflect the most current and accurate data available from the EMA.