CompletedPhase 2

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

China125 participantsStarted 2021-03-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC).
✓. Have progressive disease during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.
✓. Have measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
✓. Have confirmed programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% in tumor tissues tested by the central lab.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

Exclusion criteria

✕. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
✕. Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta).
✕. Evidence of complete esophageal obstruction not amenable to treatment.
✕. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention).
✕. Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug.

What they're measuring

Objective Response Rate (ORR) Assessed by the Investigator

Timeframe: Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.

Trial details

NCT IDNCT04732494

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-01

Results submitted2024-12-23

View on ClinicalTrials.gov More Esophageal Squamous Cell Carcinoma trials