Review Article

Immunotherapy for Patients with Advanced Urothelial Cancer: Current Evidence and Future Perspectives

Table 3

Ongoing clinical trials of anti-CTLA-4 immune checkpoint inhibitors in metastatic urothelial cancer.

StudyPhaseRegimenPrimary endpointsPlanned number of pts or pts enrolledStatus

Ipilimumab NCT01524991IIIV gemcitabine 1000 mg/m2 d 1,8 + cisplatin 70 mg/m2 d1 q3w. IV Ipi 10 mg/kg d1 (start c3)1 year OS36Active, not recruiting
NCT02496208IOS cabozantinib-s-malate + IV Niv IpiSafety and DLT66Currently recruiting
NCT01928394I/IIIV Niv Ipi (different schedules) cobimetinibORR1150Currently recruiting
NCT02381314IIV Ipi d1 q3w + IV enoblituzumab weeklySafety84Currently recruiting
NCT02834013 (DART)IIIV Niv d 1,15,29 + IV ipilimumab d1 q6wORR334Active, not recruiting

Tremelimumab NCT02516241IIIIV Drv IV Trm versus CT (platinum + gemcitabine)PFS, OS1005Active, not recruiting
NCT02527434IIIV Trm versus IV Trm + IV Drv versus IV DrvORR66Currently recruiting
NCT02643303I/IIIV Drv + IV tremelimumab IT/IM PolyICLCRecommended combination dose, safety, ORR, PFS, and OS102Active, not recruiting