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
BeOne Medicines
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Self-identifies as a member of racial and/or ethnic minority populations as defined by the Food and Drug Administration (FDA), such as Black or African American, Hispanic or Latino, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander * Histologically confirmed, locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma (GAC/GEA) or esophageal squamous cell carcinoma (ESCC) * No previous systemic therapy for locally advanced unresectable or metastatic GAC/GEA or ESCC * At least 1 measurable lesion per RECIST v1.1 as…
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
Location
- Bioresearch Partners Holding Hialeah HospitalHialeah, Florida