Table 2.
Overview of ongoing trials involving FGFR inhibitors (alone or in combination) in urothelial carcinoma.
Drug | Therapeutic scheme | FGFR status | Phase | Setting | Estimated Enrollment (n° participants) | Recruitment Status | Primary endpoints |
ClinicalTrials.gov identifier |
---|---|---|---|---|---|---|---|---|
Erdafitinib | Erdafitinib + JNJ-63723283 | Selected FGFR gene aberrations | Ib/II | ⩾1 line | 102 | Recruiting | phase Ib: DLT AEs phase II: ORR AEs |
NCT03473743 |
Erdafitinib versus vinflunine or docetaxel or pembrolizumab | Selected FGFR gene aberrations (based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay) | III | ⩾1 line | 631 | Recruiting | OS | NCT03390504 | |
Rogaratinib | Rogaratinib + atezolizumab | High FGFR1 or 3 mRNA expression levels | Ib/II | No prior systemic treatment and ineligibility for cisplatin-based | 210 | Recruiting | phase Ib: DLTs, TEAEs TESAEs phase II: PFS |
NCT03473756 |
Rogaratinib versus chemotherapy | FGFR1 or 3 positive | II/III | ⩾1 line | 175a | Active, not recruiting | OS | NCT03410693 | |
Vofatamab | Vofatamab + pembrolizumab | - | Ib/II | PD during or following platinum-containing chemotherapy | 74 | Recruiting | DLTs Safety and tolerability of vofatamab + pembrolizumab ORR |
NCT03123055 |
Vofatamab ± docetaxel, Or versus docetaxe l | FGFR3 mutant/fusion | I/II(b) | ⩾1 line which has not included taxane | 300 | Active, not recruiting | PFS | NCT02401542 |
Actual enrollment.
AEs, adverse events; DLTs, dose-limiting toxicities; OS, overall survival; PD, progression disease; PFS, progression free survival; TEAEs, treatment-emergent adverse events; TESAEs, treatment-emergent serious adverse events.