CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 125 enrolled
Drug / intervention
Tislelizumab +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04732494
NCT04732494Phase 2Completed

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

BeiGene·interventional·Posted Feb 1, 2021·Updated Jan 31, 2025

In Brief

A Phase 2 clinical trial evaluating Tislelizumab, Ociperlimab, and 1 other intervention for Esophageal Squamous Cell Carcinoma. Completed, enrolled 125 participants across 86 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, France, South Korea, Spain, Taiwan, Thailand
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedFeb 1, 2021
Enrollment StartMar 31, 2021
Primary CompletionFeb 1, 2023
Study CompletionDec 26, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.4 years ago

Interventions

Tislelizumabbiological

Tislelizumab is a monoclonal antibody formulated for intravenous injection.

Ociperlimabbiological

Ociperlimab is a monoclonal antibody formulated for intravenous injection.

Placebodrug

Ociperlimab placebo injection is a sterile, preservative-free solution for infusion formulated in the same buffer as ociperlimab active drug.