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:

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 Patients 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
  • NCT ID: NCT03783442

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

DrugSynonymsArms
Platinum (cisplatin or oxaliplatin) + Fluorouracil (5-FU)Arm A
Platinum (cisplatin or oxaliplatin) + capecitabineArm A
Platinum (cisplatin or oxaliplatin) + paclitaxelArm A

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalTislelizumab + chemotherapy
  • Platinum (cisplatin or oxaliplatin) + Fluorouracil (5-FU)
  • Platinum (cisplatin or oxaliplatin) + capecitabine
  • Platinum (cisplatin or oxaliplatin) + paclitaxel
Arm BActive ComparatorPlacebo + chemotherapy
  • Platinum (cisplatin or oxaliplatin) + Fluorouracil (5-FU)
  • Platinum (cisplatin or oxaliplatin) + capecitabine
  • Platinum (cisplatin or oxaliplatin) + paclitaxel

Eligibility Criteria

        Patients 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.

        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.

        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 PD-1, PD-L1 or PD-L2

          4. Patients 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 other
             indicators of severe malnutrition (Severe malnutrition may be determined using the
             Nutritional Risk Index (Shirasu, et al. 2018))

          8. Patients receiving chemotherapy doublet C (platinum and paclitaxel) must not have
             peripheral neuropathy ≥ Grade 2 at baseline

          9. Patients who recur after definitive surgery and are eligible for non-palliative
             radiation therapy and/or chemoradiotherapy.

        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:PFS - defined as the time from the date of randomization to the date of first documentation of disease progression assessed by BIRC per RECIST v1.1 or death, whichever occurs first
Time Frame:Approximately 31 months from date of the first patient randomization
Safety Issue:
Description:

Details

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

Last Updated