The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Completed
First Posted : February 13, 2018
Results First Posted : December 29, 2023
Last Update Posted : December 29, 2023
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma (ESCC) Drug: Tislelizumab Drug: Paclitaxel Drug: Docetaxel Drug: Irinotecan Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 512 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 26, 2018
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 28, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Tislelizumab
Tislelizumab on Day 1, given every 21 days
 Drug: Tislelizumab
200 mg administered intravenously (IV)
Other Name: BGB-A317
Active Comparator: Investigator chosen chemotherapy (ICC)
Paclitaxel on Day 1, given every 21 days or on a weekly schedule; OR Docetaxel on Day 1, given every 21 days; OR Irinotecan on Days 1 and 8, given every 21 days
 Drug: Paclitaxel
135-175 mg /m² administered IV , or 80-100 mg/m^2 administered IV according to local guidelines for standard of care

Drug: Docetaxel
75 mg/m^2 administered IV or 70 mg/m^2 IV in Japan

Drug: Irinotecan
125 mg/m^2 administered IV


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set [ Time Frame: Approximately 2 years and 10 months from date of first randomization ]
    OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants


Secondary Outcome Measures :
  1. Overall Survival (OS) in the PDL-1 Positive Analysis Set [ Time Frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) ]
    OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%.

  2. Objective Response Rate (ORR) in the ITT Analysis Set [ Time Frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) ]
    ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

  3. Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets [ Time Frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) ]
    ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1;

  4. Progression-free Survival (PFS) in the ITT Analysis Set [ Time Frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) ]
    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; reported for the ITT analysis set

  5. Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set [ Time Frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) ]
    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; reported for the PDL-1 Positive Analysis Set

  6. Duration of Response (DOR) in the ITT Analysis Set [ Time Frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) ]
    DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first

  7. Duration of Response (DOR) in the PDL-1 Positive Analysis Set. [ Time Frame: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) ]
    DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first

  8. Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set [ Time Frame: Baseline to Cycle 6 (21 days per cycle) ]
    Mean change from baseline in EORTC QLQ-C30 index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes

  9. HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set [ Time Frame: Baseline to Cycle 6 (21 days per cycle) ]
    Mean change from baseline in EORTC QLQ-C30 Index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes

  10. HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set [ Time Frame: Baseline to Cycle 6 (21 days per cycle) ]
    Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.

  11. HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set. [ Time Frame: Baseline to Cycle 6 (21 days per cycle) ]
    Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.

  12. HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set [ Time Frame: Baseline to Cycle 6 (21 days per cycle) ]
    Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.

  13. HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set [ Time Frame: Baseline to Cycle 6 (21 days per cycle) ]
    Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.

  14. Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months ]
    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization

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. 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 programmed death 1 (PD-1) or programmed death ligand 1 (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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430843


Locations
Show Show 132 study locations
Sponsors and Collaborators
BeiGene
  Study Documents (Full-Text)

Documents provided by BeiGene:
Study Protocol  [PDF] March 20, 2020
Statistical Analysis Plan  [PDF] December 22, 2020

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03430843    
Other Study ID Numbers: BGB-A317-302
2017-003699-30 ( EudraCT Number )
CTR20171026 ( Registry Identifier: ChinaDrugTrials )
First Posted: February 13, 2018    Key Record Dates
Results First Posted: December 29, 2023
Last Update Posted: December 29, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
Unresectable
metastatic
second-line
squamous
esophagus
 chemotherapy
paclitaxel
docetaxel
irinotecan
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
 Paclitaxel
Docetaxel
Irinotecan
Tislelizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Immunological