Clinical Trials /

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

NCT03783442

Description:

The purpose of this study is to evaluate the efficacy and safety of Tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic ESCC.

Related Conditions:
  • Esophageal Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
  • Official Title: A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: BGB-A317-306
  • SECONDARY ID: 2018-000587-28
  • SECONDARY ID: CTR20181013
  • SECONDARY ID: JapicCTI-194741
  • NCT ID: NCT03783442

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

DrugSynonymsArms
CisplatinPlacebo + chemotherapy
CapecitabinePlacebo + chemotherapy
PaclitaxelPlacebo + chemotherapy
Fluorouracil (5-FU)Placebo + chemotherapy
OxaliplatinPlacebo + chemotherapy
TislelizumabTislelizumab + chemotherapy
PlaceboPlacebo + chemotherapy

Purpose

The purpose of this study is to evaluate the efficacy and safety of Tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic ESCC.

Trial Arms

NameTypeDescriptionInterventions
Tislelizumab + chemotherapyExperimentalTislelizumab administered with chemotherapy doublet (any of the two available chemotherapy drug combinations) for up to 24 months
  • Cisplatin
  • Capecitabine
  • Paclitaxel
  • Fluorouracil (5-FU)
  • Oxaliplatin
  • Tislelizumab
Placebo + chemotherapyActive ComparatorPlacebo administered with chemotherapy doublet (any of the two available chemotherapy drug combinations) for up to 24 months
  • Cisplatin
  • Capecitabine
  • Paclitaxel
  • Fluorouracil (5-FU)
  • Oxaliplatin
  • Placebo

Eligibility Criteria

        Participants with unresectable, locally advanced recurrent or metastatic ESCC who have
        Stage IV unresectable ESCC at first diagnosis (ie, Stage IV disease at the original
        diagnosis of ESCC) or who have unresectable, locally advanced recurrent or metastatic
        disease with at least a 6-month treatment-free interval, if prior definitive therapy
        (chemotherapy, chemo-radiation therapy or surgery) was given.

        Key Inclusion Criteria:

          1. Pathologically (histologically) confirmed diagnosis of ESCC

          2. Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced
             recurrent or metastatic disease with a treatment free interval of at least 6 months
             after definitive treatment.

        Key Exclusion Criteria:

          1. Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation

          2. Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC

          3. Received prior therapies targeting programmed cell death protein-1 (PD-1), programmed
             cell death protein ligand-1 (PD-L1) or PD-L2

          4. Participants with evidence of fistula (either esophageal/bronchial or
             esophageal/aorta)

          5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent
             drainage or medical intervention (clinically significant recurrence requiring an
             additional intervention within 2 weeks of intervention)

          6. Evidence of complete esophageal obstruction not amenable to treatment

          7. Unintentional weight loss ≥ 5% within one month prior to randomization or Nutritional
             Risk Index (NRI) < 83.5 per investigator's choice

          8. Locally advanced esophageal carcinoma that is resectable or potentially curable with
             radiation therapy per local investigator.

          9. Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV)
             carriers whose HBV DNA is ≥ 500 IU/mL or participants with active hepatitis C virus
             (HCV)

        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:Progression-Free Survival (PFS) - defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the blinded independent review committee (BIRC) per RECIST v1.1 or death, whichever occurs first
Time Frame:Approximately 31 months from date of the first participant randomization
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:BeiGene

Last Updated

January 29, 2021