Table 3.
Ongoing clinical trials of anti-CTLA-4 immune checkpoint inhibitors in metastatic urothelial cancer.
| Study | Phase | Regimen | Primary endpoints | Planned number of pts or pts enrolled | Status | |
|---|---|---|---|---|---|---|
| Ipilimumab | NCT01524991 | II | IV gemcitabine 1000 mg/m2 d 1,8 + cisplatin 70 mg/m2 d1 q3w. IV Ipi 10 mg/kg d1 (start c3) | 1 year OS | 36 | Active, not recruiting |
| NCT02496208 | I | OS cabozantinib-s-malate + IV Niv +/− Ipi | Safety and DLT | 66 | Currently recruiting | |
| NCT01928394 | I/II | IV Niv +/− Ipi (different schedules) +/− cobimetinib | ORR | 1150 | Currently recruiting | |
| NCT02381314 | I | IV Ipi d1 q3w + IV enoblituzumab weekly | Safety | 84 | Currently recruiting | |
| NCT02834013 (DART) | II | IV Niv d 1,15,29 + IV ipilimumab d1 q6w | ORR | 334 | Active, not recruiting | |
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| Tremelimumab | NCT02516241 | III | IV Drv +/− IV Trm versus CT (platinum + gemcitabine) | PFS, OS | 1005 | Active, not recruiting |
| NCT02527434 | II | IV Trm versus IV Trm + IV Drv versus IV Drv | ORR | 66 | Currently recruiting | |
| NCT02643303 | I/II | IV Drv + IV tremelimumab +/− IT/IM PolyICLC | Recommended combination dose, safety, ORR, PFS, and OS | 102 | Active, not recruiting | |