Table 1. . Study treatments.
Treatment | Dose | Frequency | Route of administration | Dosing time of each 3-week cycle |
---|---|---|---|---|
Pembrolizumab | 200 mg | Q3W | IV infusion | Day 1 of each cycle |
Placebo (normal saline) | NA | Q3W | IV infusion | Day 1 of each cycle |
FP† | ||||
– Cisplatin‡ | 80 mg/m2¶ | Q3W | IV infusion | Day 1 of each cycle |
– 5-Fluorouracil | 800 mg/m2/day¶ | Continuous | IV infusion | Days 1–5 of each cycle |
CAPOX† | ||||
– Oxaliplatin | 130 mg/m2¶ | Q3W | IV infusion | Day 1 of each cycle |
– Capecitabine | 1000 mg/m2¶ | BID | Oral | Days 1–14 of each cycle |
SOX§ | ||||
– S-1 | <1.25 m2; BSA: 40 mg¶ 1.25 to <1.5 m2; BSA: 50 mg¶ ≥1.5 m2; BSA: 60 mg¶ |
BID | Oral | Days 1–14 of each cycle |
– Oxaliplatin | 130 mg/m2¶ | Q3W | IV infusion | Day 1 of each cycle |
– Trastuzumab | 8 mg/kg loading dose 6 mg/kg maintenance dose |
Q3W | IV infusion | Day 1 of each cycle |
Choice of chemotherapy backbone to be decided by the investigator before randomization.
Duration of cisplatin treatment may be capped at 6 cycles per local country guidelines; however, treatment with 5-fluorouracil may continue per protocol.
SOX received only by patients in the Japan-specific cohort.
Body surface area to be calculated per local guidance.
BID: Twice daily; CAPOX: Capecitabine + oxaliplatin; FP: 5-Fluorouracil + cisplatin; IV: Intravenous; Q3W: Every 3 weeks; SOX: S-1 + oxaliplatin.