Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Patients 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 patients with previously untreated inoperable or metastatic urothelial cancer.

Trial Description

Primary Outcome:

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

• Overall survival (OS) in all randomized participants
• PFS by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1) in cisplatin-ineligible randomized participants, in PD-L1 positive (≥1%) randomized participants and in all randomized participants
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Global Health Status score in all randomized participants
• OS in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC.
• European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score
• PFS in PD-L1 positive by BICR (using RECIST 1.1)
• OS by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC)

View this trial on ClinicalTrials.gov