Clinical Trials /

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03430843

Description:

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.

Related Conditions:
  • Esophageal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Esophageal Squamous Cell Carcinoma
  • Official Title: A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: BGB-A317-302
  • NCT ID: NCT03430843

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

DrugSynonymsArms
BGB-A317TislelizumabBGB-A317
Paclitaxel, or Docetaxel, or IrinotecanInvestigator chosen chemotherapy

Purpose

The purpose of this study is to evaluate the efficacy and safety of BGB-A317 as second line treatment in patients with advanced unresectable/metastatic ESCC that has progressed during or after first line therapy.

Trial Arms

NameTypeDescriptionInterventions
BGB-A317ExperimentalBGB-A317 will be administered with 200 mg intravenous dosing (IV) on Day1, given every 21 days.
  • BGB-A317
Investigator chosen chemotherapyActive ComparatorPaclitaxel 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.
  • Paclitaxel, or Docetaxel, or Irinotecan

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival (OS)
Time Frame:approximately 2 years from date of first randomization
Safety Issue:
Description:Length of time from study treatment initiation to death of any cause

Secondary Outcome Measures

Measure:Overall response rate (ORR)
Time Frame:2 years
Safety Issue:
Description:Clinical response rate of treatment (CR + PR) according to RECIST v1.1 criteria
Measure:Progression-free survival (PFS)
Time Frame:2 years
Safety Issue:
Description:The interval from study treatment initiation until the determination of disease progression according to RECIST v1.1 criteria or death
Measure:Duration of response (DOR)
Time Frame:2 years
Safety Issue:
Description:The interval from the date of the first response (complete response or partial response) is achieved to the earlier of the first documentation of definitive disease progression or death from any cause
Measure:The Health-Related Quality of Life Questionnaire
Time Frame:2 years
Safety Issue:
Description:
Measure:Safety will be analyzed through the incidence of adverse events.
Time Frame:From the first dose date to 30 days after the last dose date
Safety Issue:
Description:
Measure:Safety will be analyzed through the incidence of immune-related adverse events.
Time Frame:From the first dose date to 90 days after the last dose date
Safety Issue:
Description:
Measure:Safety will be analyzed through the incidence of serious adverse events.
Time Frame:From the first dose date to 30 days after the last dose date
Safety Issue:
Description:
Measure:Safety will be analyzed through the incidence of laboratory abnormalities.
Time Frame:From the first dose date to 30 days after the last dose date
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BeiGene

Trial Keywords

  • Unresectable
  • metastatic
  • second-line
  • squamous
  • esophagus
  • chemotherapy
  • paclitaxel
  • docetaxel
  • irinotecan

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