drugset / Trial / 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

NCT04732494 ↗

Phase 2 Completed 125 enrolled BeiGene
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2021-03-31
Primary completion
2023-02-01
Completion
2023-12-26

Outcome

Missed primary endpoint

registry p = 0.2114; Risk Difference (RD) 9.9 (95% CI -5.4 to 25.3) NCT04732494 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ociperlimab Monoclonal antibody 900 mg Intravenous
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous