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Completed

NCT Number: NCT03419897

Study of BGB-A317 in Participants With Previously Treated Unresectable HCC

This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1 monoclonal antibody BGB-A317 in participants with previously treated hepatocellular unresectable carcinoma.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

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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 HCC
  • Participants with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach
  • Has received at least 1 line of systemic therapy for unresectable HCC
  • Has at least 1 measurable lesion as defined per RECIST v1.1
  • Child-Pugh score A
  • Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  • Adequate organ function

Key Exclusion Criteria:

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
  • Prior therapies targeting PD-1 or PD-L1
  • Has known brain or leptomeningeal metastasis
  • Tumor thrombus involving main trunk of portal vein or inferior vena cava
  • Loco-regional therapy to the liver within 4 weeks before enrollment
  • Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, or acute lung diseases
  • Has received:
  • Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies
  • Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer
  • Active autoimmune diseases or history of autoimmune diseases that may relapse
  • Participant with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration

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

Treatment and study plan

Tislelizumab

Drug

Administered intravenously

Other names: BGB-A317

Primary outcomes

  1. Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC)

    Time frame: From date of first dose to primary analysis data cut-off date of 30-June-2021 (up to approximately 3 years and 3 months)

    ORR is defined as the percentage of participants with complete response (CR) and partial response (PR) as the best overall response, as determined by an IRC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.

Secondary outcomes

  1. ORR Assessed by Investigator

    Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)

    ORR is defined as the percentage of participants with CR and PR as the best overall response, as determined by investigator assessment using RECIST v1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.

  2. Duration of Response (DOR) Assessed by IRC

    Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)

    DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using RECIST v1.1

  3. DOR Event-Free Rate Assessed by IRC

    Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported

    DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using RECIST v1.1. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 12 and 24 months with 95% confidence intervals estimated using Greenwood's formula.

  4. DOR Assessed by Investigator

    Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)

    DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using RECIST v1.1

  5. DOR Event-Free Rate Assessed by Investigator

    Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported

    DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using RECIST v1.1. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 12 and 24 months with 95% confidence intervals estimated using Greenwood's formula.

  6. Progression-free Survival (PFS) Assessed by IRC

    Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)

    PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the IRC using RECIST v1.1

  7. PFS Assessed by Investigator

    Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)

    PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.1

  8. Overall Survival (OS)

    Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)

    OS is defined as the time from first study drug administration to the date of death due to any cause

  9. Disease Control Rate (DCR) Assessed by IRC

    Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)

    DCR is defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by the IRC using RECIST v1.1

  10. DCR Assessed by Investigator

    Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)

    DCR is defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by the investigator using RECIST v1.1

  11. Clinical Benefit Rate (CBR) Assessed by IRC

    Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)

    CBR is defined as the percentage of participants who have CR, PR, or SD of ≥ 24 weeks in duration as assessed by the IRC using RECIST v1.1

  12. CBR Assessed by Investigator

    Time frame: From date of first dose to end of study (up to approximately 4 years and 3 months)

    CBR is defined as the percentage of participants who have CR, PR, or SD of ≥ 24 weeks in duration as assessed by the investigator using RECIST v1.1

  13. European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analogue Score (VAS)

    Time frame: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)

    Mean change from baseline in EQ-5D-5L 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. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status

    Time frame: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)

    Mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients. 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.

  15. EORTC QLQ - Hepatocellular Carcinoma 18 Questions (HCC18): Index Scores

    Time frame: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)

    Mean change from baseline in EORTC QLQ HCC18 Index Scores. The EORTC QLQ HCC18 is a specific questionnaire module that assesses quality of life of cancer patients 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.

  16. Number of Participants With Adverse Events

    Time frame: From first dose up to 30 days after the last dose of study drug; up to approximately 4 years and 3 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 Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Feb 5, 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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