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

Browse trials for

• Carcinoma 6,741
• Carcinoma, Hepatocellular 3,182

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 94 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Lead sponsor

BeiGene is the lead sponsor of 122 studies on the registry; 3 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 31 (60%) have results posted.

Study arms

• Experimental
  Arm A: Ociperlimab + Tislelizumab + BAT1706

  Participants received tislelizumab 200 milligrams (mg) intravenously once every 3 weeks followed by BAT1706 15 milligrams per kilogram (mg/kg) intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

  Drug: Ociperlimab · Drug: Tislelizumab · Drug: BAT1706

• Experimental
  Arm B: Tislelizumab + BAT1706

  Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.

  Drug: Tislelizumab · Drug: BAT1706

Interventions

• DrugOciperlimab

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

  Also known as: BGB-A1217

• DrugTislelizumab

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

  Also known as: BGB-A317

• DrugBAT1706

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

  Also known as: Bevacizumab Injection

Primary outcomes

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

   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.

   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)

Secondary outcomes

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

   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.

   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)

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

   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.

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

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

   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.

   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)

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

   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.

   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)

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

   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.

   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)

6. Overall Survival (OS)

   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.

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

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

   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.

   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)

8. Serum Concentrations of Ociperlimab

   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.

   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)

9. Serum Concentrations of Tislelizumab

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

   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)

10. Serum Concentrations of BAT1706

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

    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)

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

    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.

    Time frame: Up to 27 months

Baseline characteristics

Study documents

• Study protocol · Mar 3, 2021
• Statistical analysis plan · Feb 22, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes