Study design: CheckMate 648 (ESCC)

Phase 3, randomized, open-label trial¹
Primary endpoints: OS and PFS (by BICR)^a in patients with tumor cell PD-L1 ≥1%¹
Secondary endpoints: OS, PFS, ORR (by BICR)^a,1

Figure adapted from Doki et al. 2022.¹

^aPer RECIST version 1.1; in patients with tumor cell PD-L1 ≥1% and then in all randomized patients. ^bFluorouracil 800 mg/m² (days 1–5) and cisplatin 80 mg/m² (day 1).

BICR, blinded independent central review; chemo, chemotherapy; ECOG PS, Eastern Cooperative Oncology Group Performance Status; ESCC, esophageal squamous cell carcinoma; IPI, ipilimumab; NIVO, nivolumab; ORR, objective response rate; OS, overall survival; PD-L1, programmed death ligand 1; PFS, progression-free survival; QxW, every x weeks; R, randomization; RECIST, Response Evaluation Criteria in Solid Tumors.

1. Doki Y, et al. N Engl J Med 2022;386:449-462.