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. 2024 Feb 26;12(3):519. doi: 10.3390/biomedicines12030519

Table 2.

Summary of the most relevant clinical trials registered on clinicaltrials.gov by November 2023, investigating the combination of FGFR inhibitors and immunotherapy drugs in 1L treatment of cisplatin-ineligible LA/mUC. Abbreviations: AEs: Adverse Events; DLT: Dose-limiting toxicities; FGFRi: Fibroblast Growth Factor Receptor Inhibitor; ICI: Immune Checkpoint Inhibitor; NCT: National Clinical Trial; ORR: Overall Response Rate; OS: Overall Survival; PFS: Progression-Free Survival; TEAEs: Treatment-Emergent Adverse Events; TESAEs: Treatment-Emergent Serious Adverse Events.

NCT Number Study Name Most Current Study Status FGFRi + ICI Combination? Target of FGFR Inhibitor Phase Primary Outcome Measures
NCT03473743 NORSE Active, not recruiting Erdafitinib + cetrelimab FGFR1-4 Ib/II DLTs (Phase I), ORR and AEs (Phase II)
NCT04045613 FIDES-02
(Cohort 3)
Completed Derazantinib + atezolizumab Pan-FGFR Ib/II ORR, Safety, and tolerability of derazantinib alone and with atezolizumab
NCT03473756 FORT-2 Active, not recruiting Rogaratinib + atezolizumab FGFR1-4 Ib/II DLTs, Number of subjects with TEAEs, drug related TEAEs, and TESAEs
NCT04003610 FIGHT-205 Terminated (business decision) Pemigatinib + pembrolizumab FGFR1-3 II PFS

as updated on 3 November 2023 on ClinicalTrials.gov.