A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
Condition: Esophageal Squamous Cell Carcinoma (ESCC)
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Intervention: Tislelizumab; Paclitaxel; Docetaxel; Irinotecan
Intervention description: 200 mg administered intravenously (IV); 135-175 mg /m² administered IV , or 80-100 mg/m^2 administered IV according to local guidelines for standard of care; 75 mg/m^2 administered IV or 70 mg/m^2 IV in Japan; 125 mg/m^2 administered IV
Intervention MeSH terms: Paclitaxel; Docetaxel; Irinotecan; Tislelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 512.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Unresectable; metastatic; second-line; squamous; esophagus; chemotherapy; paclitaxel; docetaxel; irinotecan

Summary:

      The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second
      line treatment in participants with advanced unresectable/metastatic ESCC that had progressed
      during or after first line therapy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)

          2. Tumor progression during or after first-line treatment for advanced unresectable /
             metastatic ESCC

          3. At least one measurable/evaluable lesion by Response Evaluation Criteria in Solid
             Tumors (RECIST) v1.1

          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to
             randomization

        Key Exclusion Criteria:

          1. Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable
             ESCC

          2. History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula
             within 6 months prior to randomization

          3. Tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta
             or respiratory tract) at an increased risk of fistula in the study treatment assessed
             by investigator

          4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent
             drainage

          5. Received prior therapies targeting programmed death 1 (PD-1) or programmed death
             ligand 1 (PD-L1)

          6. Prior malignancy active within the previous 2 years (exceptions include the tumor
             under investigation in this trial, and locally recurring cancers that have undergone
             curative treatment, such as resected basal or squamous cell skin cancer, superficial
             bladder cancer or carcinoma in situ of the prostate, cervix or breast)

          7. Active brain or leptomeningeal metastasis.

          8. Has active autoimmune disease or history of autoimmune diseases at high risk for
             relapse

          9. Known history of, or any evidence of interstitial lung disease, non-infectious
             pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or
             uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases,
             etc

         10. Known history of Human Immunodeficiency Virus (HIV)

         11. Has cardiovascular risk factors

         12. Pregnant or breastfeeding woman.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.