Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer

Official Title

A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer

Summary:

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.

Trial Description

Primary Outcome:

• Overall survival (OS) in cisplatin-ineligible randomized participants
• Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC)
• Progression-free survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC
• Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC

• Overall survival (OS) in all randomized participants
• Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1) in cisplatin-ineligible randomized participants
• Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1) in PD-L1 positive (≥1%) randomized participants
• Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1) in all randomized participants
• European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants
• European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in cisplatin eligible participants with previously untreated, unresectable or metastatic UC
• Progression-free survival (PFS) by BICR (using RECIST 1.1) by immunohistochemistry (IHC)
• Overall survival (OS) by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC)

View this trial on ClinicalTrials.gov