click on circles to display study description...
nivolumab alone (n=532) vs. placebo (n=262)
randomized controlled trial
nivolumab
nivolumab (at a dose of 240 mg every 2 weeks for 16 weeks, followed by nivolumab at a dose of 480 mg every 4 weeks)
placebo
Dose modifications were notpermitted, but nivolumab or placebo could be interruptedor delayed
mEC - (neo)adjuvant (NA)
The patients completedneoadjuvant chemoradiotherapy, followedby complete resection,
double-blind
170 sites in 29 countries
P3/ two sided with one interim analysis. The boundaryfor statistical significance based on 396 eventsof disease recurrence or death observed at thisinterim analysis required the P value to be lessthan 0.036.
Among patients with resected esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy, disease-free survival was significantly longer among those who received nivolumab adjuvant therapy than among those who received placebo.
pembrolizumab plus SoC (n=373) vs. placebo plus SoC (n=376)
randomized controlled trial
Pembrolizumab with cisplatin and 5 FU :
Pembrolizumab at 200 mg on day 1 of each 3-week cycle, for up to 35 cycles Cisplatin in both study arms is administered at a dose level of 50 mg/m2 on day 1 of each 3-week cycle for up to 6 cycles, and 5-FU was administered at 800 mg/m2 per day on day 1 to day 5 of each 3-week cycle for up to 35 cycles
placebo with cisplatin and 5 FU :
Cisplatin in both study arms is administered at a dose level of 50 mg/m2 on day 1 of each 3-week cycle for up to 6 cycles, and 5-FU was administered at 800 mg/m2 per day on day 1 to day 5 of each 3-week cycle for up to 35 cycles
mEC - 1st line (L1)
double-blind
across 168 medical centres in 26 countries
P3 / 1 IA and 1 final analysis: the 1st IA (= the final analysis of PFS) was planned after at least 13mo of follow-up. Overall type I error at a 1-sided at 0.25 with 0.12 to OS in patients with PD-L1> 10, 0.11 to ITT patients and 0.02 to PFS in ITT patients. Re-allocation of overall type I error to other outcomes according to graphical method p13 of the appendix
camrelizumab alone (n=228) vs. Standard of Care (SoC) (n=220)
randomized controlled trial
camrelizumab
camrelizumab 200 mg every 2 week. Dose reduction of camrelizumab was not permitted.
docetaxel or irinotecan
chemotherapy with docetaxel (75 mg/m2 every 3 weeks) or irinotecan (180 mg/m2 every 2 weeks) : docetaxel (19.5%) or irinotecan(80.5%)
mEC - 2nd line (L2)
Asian only
open label
43 hospitals in China
p3 /one sided and Interim analysis. Only OS at one sided level : 0.025 This study only involves one final analysis of the primary endpoint OS and the multiplicity issues will not be involved
Second-line camrelizumab significantly improved overall survival in patients with advanced or metastatic oesophageal squamous cell carcinoma compared with chemotherapy
nivolumab alone (n=210) vs. Standard of Care (SoC) (n=209)
randomized controlled trial
Nivolumab
Nivolumab was administered intravenously over 30 min at a dose of 240 mg every 2 weeks (each cycle was 6 weeks).
ICC Docetaxel/Paclitaxel
Paclitaxel and docetaxel were administered intravenously for at least 60 min; paclitaxel at 100 mg/m² once per week for 6 weeks followed by 1 week off (each cycle was 7 weeks) and docetaxel at 75 mg/m² every 3 weeks (each cycle was 3 weeks). paclitaxel (68.9%) docetaxel (31.1%)
Dose reductions were allowed for paclitaxel and docetaxel for toxicities prespecified in the protocol under dose reduction criteria. Dose reductions were not permitted in the nivolumab group.
mEC - 2nd line (L2)
95.7 %asian patients
open design
90 hospitals and cancer centres in Denmark, Germany, Italy, Japan, South Korea, Taiwan, the UK, and
P3/ two sided and no interim analysis (cancelled). Hierarchical testing procedure with secondary endpoint : OS then ORR then PFS
Nivolumab was associated with a significant improvement in overall survival and a favourable safety profile compared with chemotherapy in previously treated patients with advanced oesophageal squamous cell carcinoma
pembrolizumab alone (n=314) vs. Standard of Care (SoC) (n=314)
randomized controlled trial
Pembrolizumab
pembrolizumab 200 mg Q3W for up to 2 years
chemotherapy ICC (paclitaxel, docetaxel, or irinotecan)
investigator’s choice chemo of paclitaxel, docetaxel, or irinotecan.paclitaxel 80-100 mg/m on days 1, 8, and 15 Q4W, docetaxel 75 mg/m Q3W, or irinotecan 180 mg/m Q2W.
mEC - 2nd line (L2)
open design
powered by vis.js Network