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Completed

NCT Number: NCT03430843

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

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.

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Key information

Conditions

Esophageal Squamous Cell Carcinoma (ESCC) Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Imelda Ziekenhuis Bonheiden, Bonheiden, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
  • Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC
  • At least one measurable/evaluable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization

Key Exclusion Criteria:

  • Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable ESCC
  • History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization
  • 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
  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
  • Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
  • 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)
  • Active brain or leptomeningeal metastasis.
  • Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
  • 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
  • Known history of Human Immunodeficiency Virus (HIV)
  • Has cardiovascular risk factors
  • Pregnant or breastfeeding woman.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Tislelizumab

Drug

200 mg administered intravenously (IV)

Other names: BGB-A317

paclitaxel

Drug

135-175 mg /m² administered IV , or 80-100 mg/m^2 administered IV according to local guidelines for standard of care

docetaxel

Drug

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

Irinotecan

Drug

125 mg/m^2 administered IV

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Feb 13, 2018
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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