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Monoclonal Antibodies
Arm A: Tislelizumab plus Ociperlimab for Esophageal Carcinoma
Phase 2
Waitlist Available
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 32 months
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.
Eligible Conditions
- Esophageal Carcinoma
- Esophageal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 32 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 32 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR) Assessed By The Investigator's Review Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Secondary study objectives
Clinical Benefit Rate
Disease Control Rate Assessed By The IRC And The Investigator Per RECIST v1.1
Duration Of Response Assessed By The IRC And The Investigator Per RECIST v1.1
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A: Tislelizumab plus OciperlimabExperimental Treatment2 Interventions
Participants will receive tislelizumab (200 milligrams \[mg\]) plus ociperlimab (900 mg) intravenously once every 3 weeks.
Group II: Arm B: Tislelizumab plus PlaceboPlacebo Group2 Interventions
Participants will receive tislelizumab (200 mg) plus placebo intravenously once every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~4820
Ociperlimab
2021
Completed Phase 2
~1300
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Who is running the clinical trial?
BeiGeneLead Sponsor
198 Previous Clinical Trials
30,700 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,279 Previous Clinical Trials
499,863 Total Patients Enrolled
1 Trials studying Esophageal Carcinoma
1,000 Patients Enrolled for Esophageal Carcinoma
Yang HaiyangStudy DirectorBeiGene
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