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. 2019 Nov 25;11:1758835919890285. doi: 10.1177/1758835919890285

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
a

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.