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

BeiGene, Ltd.0 个研究点目标入组 280 人开始时间: 2021年2月10日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•1. Histologically confirmed diagnosis of ESCC.
•2. Have PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.
•3. Have measurable disease as assessed by RECIST v1.1.
•4. Have confirmed PD-L1 vCPS = 10% in tumor tissues tested by the central lab.
•5. ECOG PS score of 0 or 1.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 132
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 148

•1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
•2. Patients with evidence of fistula (either esophageal/bronchial or esophageal/aorta).
•3. Evidence of complete esophageal obstruction not amenable to treatment.
•4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention).
•5. 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.

发起方