A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Localized Esophageal Squamous Cell Carcinoma

This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of tislelizumab (BGB-A317) versus placebo in combination with chemoradiotherapy in participants with localized esophageal squamous cell carcinoma (ESCC).

Key Inclusion Criteria:

• Histologically confirmed diagnosis of localized ESCC and suitable for concurrent chemoradiotherapy (cCRT)
• Measurable and/or non-measurable disease defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
• Adequate organ function

Key Exclusion Criteria:

• Indicators of severe malnutrition
• Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 2 weeks prior to randomization
• Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy
• Received prior radiotherapy or therapies targeting programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1), PD-L2 or other immune-oncology therapies
• Active autoimmune diseases or history of autoimmune diseases that may relapse

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.