Table 3.
Overview of clinical trials registered on ClinicalTrials.gov by November 2023 that include patients with treatment-naïve platinum-ineligible mUC in their enrollment. Abbreviations: EZH2: enhancer of zeste homolog 2; FGFR: fibroblast growth factor receptor; N/A: not assessed; NCT: national clinical trial; ORR: objective response rate; OS: overall survival; PD-L1: programmed death ligand 1; PFS: progression-free survival; RP2D: recommended phase 2 dose; mUC: metastatic urothelial cancer.
| NCT Number + Title (If Available) | Phase + Enrollment | Study Status | Cohorts/Arms of Interest for Treatment-Naïve Platinum-Ineligible mUC | Biomarker | Primary Endpoints |
|---|---|---|---|---|---|
| NCT02573259 | Phase 1 (147) |
Completed | 5 arms with same treatment (PF-06801591) but increasing concentrations and different doses of administration | PD-L1 | Parameters related to adverse events in Part 1, ORR in Part 2 [76] |
| NCT04601857 | Phase 2 (46) |
Active, recruiting | Cohort A: Futibatinib and Pembrolizumab, for patients with a FGFR3 mutation or FGFR1-4 fusion/rearrangement. | Cohort A: FGFR3 mutation or FGFR1-4 fusion/rearrangement. | ORR [77] |
| Cohort B: Same treatment, but for all other patients than in Cohort A with UC (including patients with other FGFR or non-FGFR genetic aberrations and patients with wild type [non-mutated] tumors). | Cohort B: other FGFR or non-FGFR genetic aberrations | ||||
| NCT04486781 | Phase 2 (38) |
Active, recruiting | Combination therapy for all | Ephrin B2 | ORR [78] |
| NCT05645692 | Phase 2 (240) |
Active, recruiting | Arm A (Atezolizumab) Q3W, Arm B (IV RO7247669) Q3W and Arm C (IV RO7247669 and tiragolumab) Q3W | PD-L1 | ORR [79] |
| NCT03854474 | Phase 1|Phase 2 (30) |
Active, recruiting | Experimental: Treatment (tazemetostat, pembrolizumab) | EZH2 and H3K27me3 chromatin methylation | RP2D [80] |
|
NCT03898180 [LEAP-011] |
Phase 3 (487) |
Active, not recruiting | Experimental: Pembrolizumab + Levantinib; Active Comparator: Pembrolizumab + Placebo; Experimental: Pembrolizumab monotherapy | N/A | PFS and OS [81] |
|
NCT03288545 [EV-103] |
Phase 1|Phase 2 (348) |
Active, not recruiting | Cohort K: Enfortumab Vedotin + Pembrolizumab | N/A | ORR (Cohort K only) [82] |