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atezolizumab alone (n=406) vs. no additional treatment (n=403)
randomized controlled trial
atezolizumab
1200 mgintravenous atezolizumab fora total of 16 cycles or 1 year, Dose reductions ofatezolizumab were not permitted.
observation
Crossover was not permitted
MIBC - NA - all population
selction regardless of PDL1 status
opan-label
192 hospitals, academic centres, and community oncology practices across 24 countries or regions
P3/ two sided with two interim analysis (OS). If results from the disease-freesurvival analysis were significant at an α value of 0·05,the analysis of overall survival was to be performed at anα level of 0·05,
IMvigor010 study evaluating Tecentriq ® (atezolizumab) as an adjuvant (after surgery) monotherapy treatment did not meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC)
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.
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.
atezolizumab alone (n=467) vs. Standard of Care (SoC) (n=464)
randomized controlled trial
atezolizumab
atezolizumab 1200 mg intravenously every 3 weeks
chemotherapy
chemotherapy (vinflunine 320 mg/m² (54.6%), paclitaxel 175 mg/m² (33.4%), or docetaxel 75 mg/m²(12.0%) intravenously every 3 weeks
No prespecified crossover was planned per protocol.
mUC - L2 - all population
open label
217 academic medical centres and community (results from 198 sites)
P3/two sided no AI planned. Tested with a hierarchical fixed-sequence procedure based on a stratified log-rank test at a two-sided level of 5% significance
The sponsor has revealed that its phase III IMVigor 211 failed to meet the primary endpoint of extending overall survival compared with chemotherapy. Roche withdraws Atezolizumab in platinum refractory UC after FDA discussions
atezolizumab alone (n=316) vs. Standard of Care (SoC) (n=309)
randomized controlled trial
atezolizumab
atezolizumab 1200 mg intravenously every 3 weeks
chemotherapy
chemotherapy (vinflunine 320 mg/m², paclitaxel 175 mg/m², or docetaxel 75 mg/m²) intravenously every 3 weeks (no % for this sub-population)
No prespecified crossover was planned per protocol.
mUC - L2 - PDL1 positive
IC1/2/3 patients as planned as step 1 of the hierarchical testing
open label
217 academic medical centres and community (results from 198 sites)
P3/two sided no AI planned. Tested with a hierarchical fixed-sequence procedure based on a stratified log-rank test at a two-sided level of 5% significance
The sponsor has revealed that its phase III IMVigor 211 failed to meet the primary endpoint of extending overall survival compared with chemotherapy.Roche withdraws Atezolizumab in platinum refractory UC after FDA discussions
atezolizumab alone (n=116) vs. Standard of Care (SoC) (n=118)
randomized controlled trial
atezolizumab
atezolizumab 1200 mg intravenously every 3 weeks
chemotherapy
chemotherapy (vinflunine 320 mg/m², paclitaxel 175 mg/m², or docetaxel 75 mg/m²) intravenously every 3 weeks (no % for this sub-population)
No prespecified crossover was planned per protocol.
mUC - L2 - PDL1 positive
IC2/3 patients as planned as step 1 of the hierarchical testing
open label
217 academic medical centres and community (results from 198 sites)
P3/two sided no AI planned. Tested with a hierarchical fixed-sequence procedure based on a stratified log-rank test at a two-sided level of 5% significance
The sponsor has revealed that its phase III IMVigor 211 failed to meet the primary endpoint of extending overall survival compared with chemotherapy.Roche withdraws Atezolizumab in platinum refractory UC after FDA discussions.
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