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