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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.
durvalumab alone (n=346) vs. gemcitabine plus platin (n=344)
randomized controlled trial
durvalumab
durvalumab monotherapy (at a fixed dose of 1500 mg, administered intravenously every 4 weeks) Dose reductions were not permitted for durvalumab or durvalumab plus tremelimumab.
platine based chemotherpy (SOC) cisplatine plus gemcitabine
IV infusions of cisplatin at a dose of 70 mg/m2 on day 2 of each 28-day cycle plus gemcitabine at 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle, for up to six cycles; OR IV infusions of cisplatin at 70 mg/m2 on day 1 of each 21-day cycle plus gemcitabine at 1000–1250 mg/m2 on days 1 and 8 of each 21-day cycle, for up to six cycles
3 arms : durvalumab alone or with tremelimumab vs SOC; crossover from the chemotherapy group to either the durvalumab or durvalumab plus tremelimumab groups was not allowed
mUC - L1 - all population
Patients who had received adjuvant or neoadjuvant treatment for locally advanced disease and had progressed within 6 months of their last therapy or surgery were also excluded.
open label
243 academic research centres, hospitals, and oncology clinics in 23 countries
P3/ two sided and two interim analysis. Splitting alpha between coprimary endpoint and recycling with hierachical testing procedure for OS ITT (D) and PDL1 high (DT)
This study did not meet either of its coprimary endpoints (OS).
durvalumab plus tremelimumab (n=342) vs. gemcitabine plus platin (n=344)
randomized controlled trial
durvalumab plus tremelimumab
durvalumab monotherapy (at a fixed dose of 1500 mg, administered intravenously every 4 weeks) Dose reductions were not permitted for durvalumab or durvalumab plus tremelimumab.
platine based chemotherpy
IV infusions of cisplatin at a dose of 70 mg/m2 on day 2 of each 28-day cycle plus gemcitabine at 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle, for up to six cycles; OR IV infusions of cisplatin at 70 mg/m2 on day 1 of each 21-day cycle plus gemcitabine at 1000–1250 mg/m2 on days 1 and 8 of each 21-day cycle, for up to six cycles
3 arms : durvalumab alone or with tremelimumab vs SOC; crossover from the chemotherapy group to either the durvalumab or durvalumab plus tremelimumab groups was not allowed
mUC - L1 - all population
Patients who had received adjuvant or neoadjuvant treatment for locally advanced disease and had progressed within 6 months of their last therapy or surgery were also excluded
open label
243 academic research centres, hospitals, and oncology clinics in 23 countries
P3/ two sided and two interim analysis. Splitting alpha between coprimary endpoint and recycling with hierachical testing procedure for OS ITT (D) and PDL1 high (DT)
This study did not meet either of its coprimary endpoints.
pembrolizumab alone (n=307) vs. Standard of Care (SoC) (n=352)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg every 3 weeks (Q3W) for a maximum of 35 cycles
chemotherapy alone (cisplatine or carbo plus gemcitabine)
Investigator’s choice of cisplatin 44% [70 mg/m2 Q3W] plus gemcitabine [1000 mg/m2 on days 1 and 8 Q3W] OR carboplatin 56% [AUC 5Q3W] plus gemcitabine if cisplatin ineligible)
3 arms: pembrolizumab ± chemotherapy versus chemotherapy Dose modifications for pembrolizumab were not permitted;
mUC - L1 - all population
open label
201 medical centres in 21 countries
A Bonferroni approachwas used to control the type I error rate at α=0·025(one-sided), with 0·005 allocated to progressionfree survival and 0·02 allocated to overall survival.A sequential testing strategy was used
Results from the trial indicated that the PD-1 inhibitor plus chemotherapy failed to result in a statistically significant improvement in progression-free survival (PFS) or overall survival (OS) over chemotherapy in patients with treatment-naïve advanced urothelial carcinoma
pembrolizumab plus SoC (n=351) vs. gemcitabine plus platin (n=352)
randomized controlled trial
pembrolizumab plus chemotherapy
pembrolizumab 200 mg every 3 weeks (Q3W) for a maximum of 35 cycles, [70 mg/m2 Q3W] plus gemcitabine [1000 mg/m2 on days 1 and 8 Q3W] OR carboplatin [AUC 5Q3W] plus gemcitabine if cisplatin ineligible)
chemotherapy alone (cisplatine or carbo plus gemcitabine)
Investigator’s choice of platin [70 mg/m2 Q3W] plus gemcitabine [1000 mg/m2 on days 1 and 8 Q3W] OR carboplatin [AUC 5Q3W] plus gemcitabine if cisplatin ineligible)
3 arms: pembrolizumab ± chemotherapy versus chemotherapy Dose modifications for pembrolizumab were notpermitted;
mUC - L1 - all population
open label
201 medical centres in 21 countries
A Bonferroni approachwas used to control the type I error rate at α=0·025(one-sided), with 0·005 allocated to progressionfree survival and 0·02 allocated to overall survival.A sequential testing strategy was used
Results from the trial indicated that the PD-1 inhibitor plus chemotherapy failed to result in a statistically significant improvement in progression-free survival (PFS) or overall survival (OS) over chemotherapy in patients with treatment-naïve advanced urothelial carcinoma
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