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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

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 513 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
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tislelizumab
Tislelzumab on Day 1, given every 21 days
Drug: Tislelizumab
200 mg administered intravenously (IV)
Other Name: BGB-A317

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.

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Overall response rate (ORR) [ Time Frame: 2 years ]
    Clinical response rate of treatment (CR + PR) according to RECIST v1.1 criteria

  3. 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

  4. 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

  5. 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 ]
  6. 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 ]
  7. HRQoL as Assessed by European Quality of Life 5-Dimensions Version (EQ-5D-5L Version) [ Time Frame: 2 years ]
  8. Number of participants experiencing adverse events (AEs) [ Time Frame: From the first dose date to 30 days after the last dose date ]
  9. Number of participants experiencing immune-related AEs [ Time Frame: From the first dose date to 90 days after the last dose date ]
  10. Number of participants experiencing serious adverse events (SAEs) [ Time Frame: From the first dose date to 30 days after the last dose date ]


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.


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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 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.


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 131 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Virginia Paton, Pharm.D. BeiGene
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03430843    
Other Study ID Numbers: BGB-A317-302
2017-003699-30 ( EudraCT Number )
CTR20171026 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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:
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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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors