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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03783442
Recruitment Status : Active, not recruiting
First Posted : December 21, 2018
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE December 18, 2018
First Posted Date  ICMJE December 21, 2018
Last Update Posted Date May 2, 2022
Actual Study Start Date  ICMJE December 11, 2018
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2022)
Overall Survival (OS) [ Time Frame: Up to approximately 40 months from date of the first participant randomization ]
OS is defined as the time from the date of randomization until the date of death due to any cause
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • 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 ]
  • OS - defined as the time from the date of randomization until the date of death due to any cause [ Time Frame: Approximately 31 months from date of the first patient randomization ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 26, 2022)
  • Progression-Free Survival (PFS) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
    PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first
  • Objective Response Rate (ORR) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
    ORR is defined as the proportion of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by the investigator per RECIST v1.1
  • Overall survival (OS) in the PD-L1 score ≥ 10% subgroup [ Time Frame: Approximately 40 months from date of the first participant randomization ]
    OS is defined as the time from the date of randomization until the date of death due to any cause
  • Duration of Response (DOR) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
    DOR is defined as the time from the first determination of an objective response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever comes first
  • Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
  • Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer specific module (EORTC QLQ-OES18) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
  • Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using the generic health state instrument European Quality of Life-5 Dimensions (EuroQol 5D EQ-5D-5L) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
  • Number of participants experiencing Adverse Events (AEs) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
Original Other Pre-specified Outcome Measures
 (submitted: December 19, 2018)
  • ORR - defined as the proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by BIRC per RECIST v1.1 [ Time Frame: Approximately 31 months from date of the first patient randomization ]
  • DOR- defined as the time from the first determination of an objective response until the first documentation of progression assessed by BIRC per RECIST v1.1 or death, whichever comes first [ Time Frame: Approximately 31 months from date of the first patient randomization ]
  • Health-Related Quality of Life (HRQoL) assessment of the patient's overall health status using European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30). [ Time Frame: Approximately 31 months from date of the first patient randomization ]
  • Health-Related Quality of Life (HRQoL) assessment of the patient's overall health status using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer specific module (EORTC QLQ-OES18). [ Time Frame: Approximately 31 months from date of the first patient randomization ]
  • Health-Related Quality of Life (HRQoL) assessment of the patient's overall health status using the generic health state instrument European Quality of Life- 5 Dimensions (EuroQol 5D EQ-5D-5L). [ Time Frame: Approximately 31 months from date of the first patient randomization ]
  • The incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 [ Time Frame: Approximately 31 months from date of the first patient randomization ]
 
Descriptive Information
Brief Title  ICMJE A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
Official Title  ICMJE 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
Brief Summary 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 esophageal squamous cell carcinoma (ESCC).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Squamous Cell Carcinoma (ESCC)
Intervention  ICMJE
  • Drug: Cisplatin
    60 to 80 mg/m^2 intravenously (IV) on Day 1 once every 3 weeks (Q3W)
  • Drug: Oxaliplatin
    130 mg/m^2 IV on Day 1 Q3W
  • Drug: Fluorouracil (5-FU)
    750 to 800 mg/m^2 IV continuous infusion over 24 hours daily on Days 1 to 5 Q3W
  • Drug: Capecitabine
    1000 mg/m^2 orally (PO) twice daily (BID) on Days 1 to 14 Q3W
  • Drug: Paclitaxel
    175 mg/m^2 IV on Day 1 Q3W
  • Drug: Tislelizumab
    200 mg IV Q3W
  • Drug: Placebo
    Placebo to match Tislelizumab
Study Arms  ICMJE
  • Experimental: Tislelizumab + chemotherapy

    Tislelizumab administered with chemotherapy doublet:

    Doublet A: Cisplatin or Oxaliplatin plus Fluorouracil (5-FU); Doublet B: Cisplatin or Oxaliplatin plus Capecitabine; Doublet C: Cisplatin or Oxaliplatin plus Paclitaxel

    Interventions:
    • Drug: Cisplatin
    • Drug: Oxaliplatin
    • Drug: Fluorouracil (5-FU)
    • Drug: Capecitabine
    • Drug: Paclitaxel
    • Drug: Tislelizumab
  • Active Comparator: Placebo + chemotherapy

    Placebo administered with chemotherapy doublet:

    Doublet A: Cisplatin or Oxaliplatin plus Fluorouracil (5-FU); Doublet B: Cisplatin or Oxaliplatin plus Capecitabine; Doublet C: Cisplatin or Oxaliplatin plus Paclitaxel

    Interventions:
    • Drug: Cisplatin
    • Drug: Oxaliplatin
    • Drug: Fluorouracil (5-FU)
    • Drug: Capecitabine
    • Drug: Paclitaxel
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 28, 2021)
649
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2018)
480
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (per American Joint Committee on Cancer 7th Edition), if there is prior neoadjuvant/adjuvant therapy with platinum-based chemotherapy, a treatment-free interval of at least 6 months is required.

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   China,   Czechia,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Poland,   Romania,   Russian Federation,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03783442
Other Study ID Numbers  ICMJE BGB-A317-306
2018-000587-28 ( EudraCT Number )
CTR20181013 ( Other Identifier: Center for drug evaluation, CFDA )
JapicCTI-194741 ( Registry Identifier: Japic )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party BeiGene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BeiGene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Liyun Li, MD BeiGene
PRS Account BeiGene
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP