At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed metastatic or surgically inoperable urothelial cancer (transitional cell carcinoma) of renal pelvis, ureter, bladder, or urethra
- ✓No prior systemic chemotherapy for metastatic or surgically inoperable disease
- ✓ECOG performance status 0 or 1
- ✕Disease amenable to local therapy with curative intent
- ✕Prior checkpoint inhibitor therapy (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4, or other T-cell co-stimulation/checkpoint pathway inhibitors)
- ✕Serious or uncontrolled medical disorder that may increase study risk or interfere with results
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Nivolumab, Ipilimumab, and 3 other interventions for Urothelial Cancer. Active but no longer recruiting, targeting 1,314 participants across 174 sites in 30 countries.
Detailed 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.
Study Details
Timeline
Interventions
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