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.