Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 RECIST v1.1
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization
  5. Adequate End organ function

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. Apparent 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 PD-1 or 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tislelizumab
Tislelzumab will be administered with 200 mg intravenous dosing (IV) on Day1, given every 21 days.
  • Drug: Tislelizumab
    Anti-PD-1 ANTIBODY
    Other names:
    • BGB-A317
Active Comparator
Investigator chosen chemotherapy
Paclitaxel will be administered at a dose of 135-175 mg /m² IV, Day 1, given every 21 days or 80-100mg/m2 IV given on a weekly schedule. OR docetaxel will be administered at a dose of 75 mg/m2 IV, Day 1, given 21 days. OR irinotecan will be administered at a dose of 125mg/m2 IV, Day 1, 8, given 21 days.
  • Drug: Paclitaxel, or Docetaxel, or Irinotecan
    One of the following three single-agent chemotherapies as determined by the Investigator Paclitaxel, or Docetaxel, or Irinotecan

More Details

Status
Active, not recruiting
Sponsor
BeiGene

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.