NCT04732494

Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Tislelizumab	Tislelizumab is a monoclonal antibody formulated for intravenous injection.
BIOLOGICAL	Ociperlimab	Ociperlimab is a monoclonal antibody formulated for intravenous injection.
DRUG	Placebo	Ociperlimab placebo injection is a sterile, preservative-free solution for infusion formulated in the same buffer as ociperlimab active drug.

Timeline

• Start date: 2021-03-31
• Primary completion: 2023-02-01
• Completion: 2023-12-26
• First posted: 2021-02-01
• Last updated: 2025-01-31
• Results posted: 2025-01-31

Locations

86 sites across 6 countries: China, France, South Korea, Spain, Taiwan, Thailand