Phase 2
N=125
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
Esophageal Squamous Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04732494 ↗Enrolled (actual)
125
Serious AEs
44.0%
Results posted
Jan 2025
Primary outcome: Primary: Objective Response Rate (ORR) Assessed by the Investigator — 30.6; 20.6 percentage of participants — p=0.2114
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tislelizumab (Biological); Ociperlimab (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BeiGene
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Assessed by the Investigator |
30.6; 20.6 | 0.2114 |
| SECONDARY Overall Survival |
10.2; 9.3 | — |
| SECONDARY Objective Response Rate Assessed by the Independent Review Committee |
32.3; 25.4 | — |
| SECONDARY Progression-free Survival (PFS) Assessed by the Independent Review Committee |
3.6; 2.8 | — |
| SECONDARY Progression-free Survival (PFS) Assessed by the Investigator |
3.4; 3.4 | — |
| SECONDARY Duration Of Response (DOR) Assessed by the Independent Review Committee |
14.6; NA | — |
| SECONDARY Duration Of Response (DOR) Assessed by the Investigator |
11.3; NA | — |
| SECONDARY Disease Control Rate Assessed by the IRC And the Investigator |
61.3; 58.7; 64.5; 58.7 | — |
| SECONDARY Clinical Benefit Rate Assessed by the IRC and the Investigator |
33.9; 30.2; 32.3; 27.0 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores |
1.7; -0.1; 0.3; -2.8; -0.5; 1.2 | — |
| SECONDARY Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain Scales |
-5.9; 4.1; -3.5; 7.3; -1.6; -1.3 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
58; 60; 28; 28; 27; 28 | — |
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.
Eligibility Criteria
Key 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.
Key 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04732494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.