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Trial record 1 of 5 for:    BGB-A317 | Esophageal
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A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second 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: NCT03430843
Recruitment Status : Active, not recruiting
First Posted : February 13, 2018
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE January 29, 2018
First Posted Date  ICMJE February 13, 2018
Last Update Posted Date June 26, 2020
Actual Study Start Date  ICMJE January 26, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2020)
Overall survival (OS) in the Intention-to-Treat (ITT) Analysis Set [ Time Frame: approximately 2 years from date of first randomization ]
Length of time from study treatment initiation to death of any cause
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
Overall survival (OS) [ Time Frame: approximately 2 years from date of first randomization ]
Length of time from study treatment initiation to death of any cause
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2020)
  • Overall survival (OS) in the PDL-1 Positive Analysis Set [ Time Frame: Up to 2 years from date of first randomization ]
    Length of time from study treatment initiation to death of any cause
  • Overall response rate (ORR) [ Time Frame: 2 years ]
    Clinical response rate of treatment (CR + PR) according to RECIST v1.1 criteria
  • Progression-free survival (PFS) [ Time Frame: 2 years ]
    The interval from study treatment initiation until the determination of disease progression according to RECIST v1.1 criteria or death
  • Duration of response (DOR) [ Time Frame: 2 years ]
    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
  • Health-Related Quality of Life (HRQoL) as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) [ Time Frame: 2 years ]
  • HRQoL as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophagus Cancer Module (EORTC QLQ-OES18) [ Time Frame: 2 years ]
  • HRQoL as Assessed by European Quality of Life 5-Dimensions Version (EQ-5D-5L Version) [ Time Frame: 2 years ]
  • Number of participants experiencing adverse events (AEs) [ Time Frame: From the first dose date to 30 days after the last dose date ]
  • Number of participants experiencing immune-related AEs [ Time Frame: From the first dose date to 90 days after the last dose date ]
  • Number of participants experiencing serious adverse events (SAEs) [ Time Frame: From the first dose date to 30 days after the last dose date ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
  • Objective response rate (ORR) [ Time Frame: 2 years ]
    Clinical response rate of treatment (CR + PR) according to RECIST v1.1 criteria
  • Progression-free survival (PFS) [ Time Frame: 2 years ]
    The interval from study treatment initiation until the determination of disease progression according to RECIST v1.1 criteria or death
  • Duration of response (DOR) [ Time Frame: 2 years ]
    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
  • The Health-Related Quality of Life Questionnaire [ Time Frame: 2 years ]
  • 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 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 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 will be analyzed through the incidence of laboratory abnormalities. [ Time Frame: From the first dose date to 30 days after the last dose date ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Squamous Cell Carcinoma (ESCC)
Intervention  ICMJE
  • Drug: Tislelizumab
    200 mg administered intravenously (IV)
    Other Name: BGB-A317
  • Drug: Paclitaxel
    135-175 mg /m² administered IV given every 21 days, or 80-100mg/m2 administered IV weekly
  • Drug: Docetaxel
    75 mg/m2 administered IV
  • Drug: Irinotecan
    125mg/m2 administered IV
Study Arms  ICMJE
  • Experimental: Tislelizumab
    Tislelzumab on Day 1, given every 21 days
    Intervention: Drug: Tislelizumab
  • Active Comparator: Investigator chosen chemotherapy

    Paclitaxel will be administered on Day 1, given every 21 days or on a weekly schedule.

    OR docetaxel will be administered on Day 1, given 21 days. OR irinotecan will be administered on Days 1, 8, given 21 days.

    Interventions:
    • Drug: Paclitaxel
    • Drug: Docetaxel
    • Drug: Irinotecan
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: March 18, 2020)
513
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2018)
450
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key 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

Key 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.

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 Belgium,   China,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03430843
Other Study ID Numbers  ICMJE BGB-A317-302
2017-003699-30 ( EudraCT Number )
CTR20171026 ( Registry Identifier: Center for drug evaluation, CFDA )
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
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Virginia Paton, Pharm.D. BeiGene
PRS Account BeiGene
Verification Date June 2020

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