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Completed

NCT Number: NCT04948697

A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC

This was a Phase 2, randomized, multicenter, open-label, 2-arm study to investigate the efficacy and safety of ociperlimab in combination with tislelizumab plus BAT1706, and tislelizumab plus BAT1706, as first-line treatment in participants with advanced Hepatocellular Carcinoma (HCC).

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Key information

Conditions

Advanced Hepatocellular Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Criteria:

Inclusion criteria

  • Histologically confirmed HCC
  • Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease that was not amenable to or had progressed after loco-regional therapy, and was not amenable to a curative treatment approach
  • Tumor tissue required for an evaluable programmed cell death protein-ligand 1 (PD-L1) expression result
  • No prior systemic therapy for HCC
  • At least 1 measurable lesion as defined per RECIST v1.1
  • Adequate organ function during screening and before randomization

Exclusion criteria

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
  • Prior therapy with antibody or drug specifically targeting T-cell costimulation or checkpoint pathway; prior treatment with bevacizumab or its biosimilars
  • Prior history of >= Grade 2 hepatic encephalopathy
  • Leptomeningeal disease or uncontrolled, untreated brain metastasis
  • Active autoimmune diseases or history of autoimmune diseases that may relapse
  • History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases
  • Infection (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days of randomization
  • Prior allogeneic stem cell transplantation or organ transplantation
  • Significant cardiovascular risk factors
  • Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding
  • History of severe hypersensitivity reactions to other monoclonal antibodies
  • Administered a live vaccine <=28 days before randomization

NOTE: Other protocol Inclusion/Exclusion criteria may apply

Treatment and study plan

Ociperlimab

Drug

900 mg intravenously once every 3 weeks (dosed in 21-day cycles)

Other names: BGB-A1217

Tislelizumab

Drug

200 mg intravenously once every 3 weeks (dosed in 21-day cycles)

Other names: BGB-A317

BAT1706

Drug

15 mg/kg intravenously once every 3 weeks (dosed in 21-day cycles)

Other names: Bevacizumab Injection

Primary outcomes

  1. Objective Response Rate (ORR) as Assessed by the Investigator

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)

    ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors version(v) 1.1 (RECIST v1.1). Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Secondary outcomes

  1. Duration Of Response (DOR) as Assessed by the Investigator

    Time frame: From the first confirmed objective response until the first documentation of disease progression or death, whichever came first (i.e. up to 27 months)

    DOR was defined as the time from the date of first documentation of a partial response (PR) or better to the date of first documentation of progressive disease or death whichever comes first, assessed based on RECIST v1.1. Median DOR was estimated using the Kaplan-Meier method. Per RECIST v1.1, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.

  2. Time to Response (TTR) as Assessed by the Investigator

    Time frame: From the randomization date to the first documentation of response (up to 27 months)

    TTR was defined as the time from the randomization date to the date of first documented partial response (PR) or better by the investigator, assessed based on RECIST v1.1. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  3. Disease Control Rate (DCR) as Assessed by the Investigator

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)

    DCR was defined as the percentage of participants who achieve complete response (CR), partial response (PR) or stable disease (SD), assessed based on RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

  4. Clinical Benefit Rate (CBR) as Assessed by the Investigator

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)

    CBR was defined as the percentage of participants who achieve complete response (CR), partial response (PR), or durable stable disease (stable disease defined as >= 24 weeks). Per RECIST 1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  5. Progression-Free Survival (PFS) as Assessed by the Investigator

    Time frame: From the randomization date to the date of first documentation of disease progression or death, whichever came first (i.e., up to 27 months)

    PFS was evaluated by the investigator according to RECIST version 1.1; and was defined as the time from the randomization date to the date of first documentation of disease progression or date of death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Per RECIST v 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.

  6. Overall Survival (OS)

    Time frame: From the randomization date until the date of death from any cause (up to 27 months)

    OS was defined as the time from the randomization date until the date of death from any cause. Median OS was estimated using the Kaplan-Meier method.

  7. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: From the date of the first dose of study drug up to 30 days after last dose of study drug (i.e., up to 27 months)

    A TEAE was defined as an adverse event (AE) that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study drug(s) and up to 30 days after the last dose of study drug(s), or initiation of new anticancer therapy, whichever occurs first. AEs were graded for severity using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0, where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; and Grade 5: Death related to AE. The TEAEs leading to death in this data table exclude death due to disease under study.

  8. Serum Concentrations of Ociperlimab

    Time frame: Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days)

    Serum samples were assayed for ociperlimab concentrations using a validated immunoassay. This outcome measure was not analyzed for Arm B as ociperlimab was not administered in Arm B.

  9. Serum Concentrations of Tislelizumab

    Time frame: Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days)

    Serum samples were assayed for tislelizumab concentrations using a validated immunoassay.

  10. Serum Concentrations of BAT1706

    Time frame: Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days)

    Serum samples were assayed for BAT1706 concentrations using a validated immunoassay.

  11. Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706

    Time frame: Up to 27 months

    Serum samples were tested for the presence of ADAs to ociperlimab, tislelizumab and BAT1706 using a validated immunoassay. The analysis included: Treatment-emergent ADA: sum of treatment-boosted ADA patients and treatment-induced ADA participants as a percentage of the ADA-evaluable participants population; Treatment-boosted ADA: Baseline-positive ADA-evaluable patients with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period; and Treatment-induced ADA: ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period.

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

A Phase 2, Randomized, Open-labeled Clinical Study Investigating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab Plus BAT1706 and of Tislelizumab Plus BAT1706 as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 2, 2021
Registry last updated
Feb 24, 2025

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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