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

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: NCT04948697
Recruitment Status : Active, not recruiting
First Posted : July 2, 2021
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
This is 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 HCC.

Condition or disease Intervention/treatment Phase
Advanced Hepatocellular Carcinoma Drug: Ociperlimab Drug: Tislelizumab Drug: BAT1706 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 20, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Arm Intervention/treatment
Experimental: Arm A: ociperlimab + tislelizumab + BAT1706
tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks
Drug: Ociperlimab
900 mg intravenously once every 3 weeks (dosed in 21-day cycles)
Other Name: BGB-A1217

Drug: Tislelizumab
200 mg intravenously once every 3 weeks (dosed in 21-day cycles)
Other Name: BGB-A317

Drug: BAT1706
15 mg/kg intravenously once every 3 weeks (dosed in 21-day cycles)
Other Name: Bevacizumab Injection

Experimental: Arm B: tislelizumab + BAT1706
tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks
Drug: Tislelizumab
200 mg intravenously once every 3 weeks (dosed in 21-day cycles)
Other Name: BGB-A317

Drug: BAT1706
15 mg/kg intravenously once every 3 weeks (dosed in 21-day cycles)
Other Name: Bevacizumab Injection




Primary Outcome Measures :
  1. Objective Response Rate (ORR) as assessed by the investigator [ Time Frame: Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1


Secondary Outcome Measures :
  1. Duration of Response (DOR) as assessed by the investigator [ Time Frame: time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first. assessed up to 24 months ]
    DOR is the time from the date of first documentation of a partial response (PR) or better to the date of first documentation of progressive disease (PR or better). DOR will be assessed based on RECIST v1.1.

  2. TIme to Response (TTR) as assessed by the investigator [ Time Frame: time from the date of first dose of study drug to the first documentation of response, assessed up to 24 months ]
    TTR is defined as the time from the date of first dose administration to the date of first documented partial response (PR) or better by the investigator. TTR will be assessed based on RECIST v1.1.

  3. Disease Control Rate (DCR) as assessed by the investigator [ Time Frame: time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first, assessed up to 24 months ]
    DCR is defined as the percentage of participants who achieve complete response (CR), partial response (PR) or durable stable disease (stable disease defined as greater than or equal to (≥) 24 weeks)). The DCR will be assessed based on RECIST v1.1.

  4. Clinical Benefit Rate (CBR) [ Time Frame: time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first, assessed up to 24 months ]
    defined as the proportion of participants who achieve complete response (CR), partial response (PR), or durable stable disease (stable disease defined as greater than or equal to (≥) 24 weeks)

  5. PFS as assessed by the investigator [ Time Frame: time from the date of the first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first, assessed up to 24 months ]
    PFS will be evaluated by the investigator according to RECIST version 1.1. PFS is defined as the time from the date of first dose to the date of first documentation of disease progression or date of death from any cause, whichever occurs first

  6. Overall Survival (OS) [ Time Frame: time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months ]
    measured time from the date of the first dose of study drug until the date of death from any cause

  7. Incidence and severity of adverse events (AEs), [ Time Frame: time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months ]
    severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0, vital signs and clinical laboratory test results

  8. Serum concentrations of ociperlimab at specified timepoints [ Time Frame: Through study completion, up to 24 months ]
    Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17. Postdose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit

  9. Serum concentrations of tislelizumab at specified timepoints [ Time Frame: Through study completion, up to 24 months ]
    Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17. Postdose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit

  10. Serum concentrations of BAT1706 at specified timepoints [ Time Frame: Through study completion, up to 24 months ]
    Collected at time intervals: predose on Day 1 of Cycles 1,2, 5, 9, and 17. Postdose on Day 1of Cycles 1 and 5 and EOT Visit

  11. Immunogenic Response to ociperlimab [ Time Frame: Through study completion, up to 24 months ]
    evaluated through detection of antidrug antibodies (ADAs). Time to onset of immunogenic response will be reported Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at Safety Follow-up Visit

  12. Immunogenic Response to tislelizumab [ Time Frame: Through study completion, up to 24 months ]
    evaluated through detection of antidrug antibodies (ADAs). Time to onset of immunogenic response will be reported Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at Safety Follow-up Visit

  13. Immunogenic Response to BAT1706 [ Time Frame: Through study completion, up to 24 months ]
    evaluated through detection of antidrug antibodies (ADAs). Time to onset of immunogenic response will be reported Collected at time intervals: predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at EOT Visit



Information from the National Library of Medicine

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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

Criteria:

Inclusion Criteria:

  1. Histologically confirmed HCC
  2. BCLC Stage C disease, or BCLC Stage B disease that is not amenable to or has progressed after loco-regional therapy, and is not amenable to a curative treatment approach
  3. Tumor tissue required for an evaluable PD-L1 expression result
  4. No prior systemic therapy for HCC
  5. At least 1 measurable lesion as defined per RECIST v1.1
  6. Adequate organ function during screening and before randomization

Exclusion Criteria:

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

NOTE: Other protocol 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): NCT04948697


Locations
Show Show 25 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Vincent Li, MD BeiGene, Ltd.
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04948697    
Other Study ID Numbers: AdvanTIG-206
First Posted: July 2, 2021    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Tislelizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents