An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy in a First-Line Setting for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in US Racial and Ethnic Minority Patients
Summary
The purpose of this study is to characterize the clinical effects of tislelizumab, including pharmacokinetics (PK), activity, and safety assessments in US racial and ethnic minority patients with human epidermal growth factor receptor 2 (HER2)-negative, programmed death-ligand 1(PD-L1)-positive, unresectable or metastatic gastric or gastroesophageal cancer (GAC/GEA) or esophageal squamous cell carcinoma (ESCC). The study duration will be up to approximately 6 years.
Arms & interventions
- DrugTislelizumab
Administered by intravenous infusion
- DrugCapecitabine
Administered orally
- Drug5-fluorouracil (5-FU)
Administered by intravenous infusion
- DrugOxaliplatin
Administered by intravenous infusion
- DrugLeucovorin
Administered by intravenous infusion
Outcome measures
Primary
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, severity (National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 \[NCI-CTCAEv5.0\]\[1\]), timing, seriousness, and relationship to study treatment in GAC/GEA and ESCC participants, respectively
Time frame: Approximately 12 months
Secondary
Overall Response Rate (ORR) as Assessed by the Investigator
Time frame: Approximately 12 months
Serum Concentrations of Tislelizumab
Time frame: Approximately 12 months
Percentage of Participants with Antidrug Antibodies (ADAs) to Tislelizumab
Time frame: Approximately 12 months
Eligibility criteria
Study locations (1)
Bioresearch Partners Holding Hialeah Hospital
Hialeah, Florida, 33013-3804