IMvigor-130 (At-arm A vs Pl-arm C), 2020 NCT02807636
atezolizumab plus SoC (n=451) vs. placebo plus SoC (n=400)
randomized controlled trial
atezolizumab (A) plus gemcitabine and platine
atezolizumab (1200 mg administered intravenously on day 1 of each cycle with 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
placebo (C) plus gemcitabine and platine
atezolizumab matched-placebo and 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
No crossover will be allowed from the control arm to either experimental arm
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 significantly prolonged progression-free survival in patients with metastatic urothelial carcinoma.