IMvigor-130 (At-arm B vs Ch-armC), 2020 NCT02807636
atezolizumab alone (n=360) vs. gemcitabine plus platin (n=400)
randomized controlled trial
atezolizumab (B)
atezolizumab (1200 mg administered intravenously on day 1 of each cycle
chemotherapy (C) gemcitabine plus platine
21-day cycles of gemcitabine (1000 mg/m² body surface area, administered intravenously on days 1 and 8 of each cycle), plus either carboplatin (area under the curve of 4·5 mg/mL per min administered intravenously) or cisplatin (70 mg/m² body surface area administered intravenously) on day 1 of each cycle
mUC - L1 - all population
open-design
221 sites in 35 countries
P3/ one sided 0,025 and interim analysis (resultats rentrés = AI1). Repartition and hierarchy OS / PFS (A vs C) then OS (B vs C)
Addition of atezolizumab to platinum-based chemotherapy as first-line treatment prolonged progression-free survival in patients with metastatic urothelial carcinoma.