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:

• Progression free survival (PFS) in cisplatin-ineligible participants using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
• Overall survival (OS) of cisplatin-ineligible participants
• PFS based on BICR assessment of nivolumab combined with standard of care (SOC) chemotherapy to SOC chemotherapy in cisplatin-ineligible participants with previously untreated, unresectable or metastatic Urothelial Cancer (UC)

• Progression free survival (PFS) in all participants using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
• Overall survival (OS) in all participants
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Global Health Status score
• OS in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC.

View this trial on ClinicalTrials.gov