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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
pembrolizumab alone (n=270) vs. Standard of Care (SoC) (n=272)
randomized controlled trial
pembrolizumab
pembrolizumab at dose of 200 mg every 3 weeks
chemotherapy (ICC) : paclitaxel, docetaxel, or vinflunine
investigator's choice of chemotherapy with paclitaxel (30.9%), docetaxel (30.9%), or vinflunine(32.0%) : paclitaxel (at a dose of 175 mg per square meter of body-surface area), docetaxel (at a dose of 75 mg per square meter), or vinflunine (at a dose of 320 mg per square meter), all administered intravenously every 3 weeks.
There was no planned crossover on disease progression.
mUC - L2 - all population
open-label
120 sites in 29 countries
P3 / one sided and two interim analysis. Repartition and hierachical testing procedure between coprimary endpoints
Pembrolizumab was associated with significantly longer overall survival (by approximately3 months) and with a lower rate of treatment-related adverse events than chemotherapyas second-line therapy for platinum-refractory advanced urothelial carcinoma.
pembrolizumab alone (n=74) vs. Standard of Care (SoC) (n=90)
randomized controlled trial
pembrolizumab
pembrolizumab at dose of 200 mg every 3 weeks
chemotherapy (ICC)
investigator's choice of chemotherapy with paclitaxel, docetaxel, or vinflunine : paclitaxel (at a dose of 175 mg per square meter of body-surface area), docetaxel (at a dose of 75 mg per square meter), or vinflunine (at a dose of 320 mg per square meter), all administered intravenously every 3 weeks.(no % for this sub-population)
There was no planned crossover on disease progression.
mUC - L2 - PDL1 positive
open-label
120 sites in 29 countries
P3 / one sided and two interim analysis. Repartition and hierachical testing procedure between coprimary endpoints
Pembrolizumab was associated with significantly longer overall survival (by approximately3 months) and with a lower rate of treatment-related adverse events than chemotherapyas second-line therapy for platinum-refractory advanced urothelial carcinoma.
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