A Study of Tislelizumab (BGB-A317) Plus 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

Phase 1

• Conditions: PD-L1 vCPS = 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-004658-32-FR
• Lead Sponsor: BeiGene, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-10
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified