Clinical Trials /

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

NCT03777657

Description:

This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
  • Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) Plus Platinum and Fluoropyrimidine Versus Placebo Plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Clinical Trial IDs

  • ORG STUDY ID: BGB-A317-305
  • SECONDARY ID: 2018-000312-24
  • SECONDARY ID: CTR20181841
  • SECONDARY ID: JapicCTI-194799
  • NCT ID: NCT03777657

Conditions

  • Gastric, or Gastroesophageal Junction Adenocarcinoma

Interventions

DrugSynonymsArms
TislelizumabBGB-A317Tislelizumab (BGB-A317) + chemotherapy
PlaceboPlacebo + chemotherapy
CisplatinPlacebo + chemotherapy
OxaliplatinPlacebo + chemotherapy
CapecitabinePlacebo + chemotherapy
5-FUPlacebo + chemotherapy

Purpose

This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Trial Arms

NameTypeDescriptionInterventions
Tislelizumab (BGB-A317) + chemotherapyExperimentalTislelizumab and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-Fluorouracil regimens are used as the backbone chemotherapy.
  • Tislelizumab
  • Cisplatin
  • Oxaliplatin
  • Capecitabine
  • 5-FU
Placebo + chemotherapyPlacebo ComparatorPlacebo and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-FU regimens are used as the backbone chemotherapy.
  • Placebo
  • Cisplatin
  • Oxaliplatin
  • Capecitabine
  • 5-FU

Eligibility Criteria

        Key Inclusion Criteria:

          1. Locally advanced unresectable or metastatic GC or GEJ carcinoma and have
             histologically confirmed adenocarcinoma

          2. No previous systemic therapy for locally advanced unresectable or metastatic
             gastric/GEJ cancer. NOTE: Participants may have received prior neoadjuvant or adjuvant
             therapy as long as it was completed and have no recurrence or disease progression for
             at least 6 months.

          3. ECOG PS ≤ 1 within 7 days prior to randomization

          4. Adequate organ function as indicated by the following laboratory values ≤ days prior
             to randomization

        Key Exclusion Criteria:

          1. Has squamous cell or undifferentiated or other histological type GC

          2. Active leptomeningeal disease or uncontrolled brain metastasis

          3. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2

          4. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug
             specifically targeting T-cell co-stimulation or checkpoint pathways

        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:Up to 48 months
Safety Issue:
Description:The time from the date of randomization to the date of death due to any cause

Secondary Outcome Measures

Measure:Progression-free survival (PFS)
Time Frame:Up to 30 months
Safety Issue:
Description:The time from the date of randomization to the date of the first objectively documented tumor progression
Measure:Overall response rate (ORR)
Time Frame:Up to 48 months
Safety Issue:
Description:The proportion of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1
Measure:Duration of response (DOR)
Time Frame:Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
Safety Issue:
Description:The time from the first determination of an objective response per Response Evaluation Criteria in Solid Tumors v1.1, until the first documentation of progression or death, whichever occurs first
Measure:Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22)
Time Frame:Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
Safety Issue:
Description:
Measure:Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (EORTC QLQ-30)
Time Frame:Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
Safety Issue:
Description:
Measure:Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score (EQ-5D-5L)
Time Frame:Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
Safety Issue:
Description:
Measure:Number of participants experiencing Adverse Events (AEs)
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Number of participants experiencing Serious Adverse Events (SAEs)
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Disease control rate (DCR)
Time Frame:Up to 48 Months
Safety Issue:
Description:Proportion of complete response + partial response + stable disease
Measure:clinical benefit rate (CBR)
Time Frame:Up to 48 Months
Safety Issue:
Description:Proportion of complete response + partial response + durable stable disease
Measure:time to response (TTR)
Time Frame:Up to 48 Months
Safety Issue:
Description:Time from randomization to the first determination of an objective response

Details

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

Last Updated

August 24, 2020