Back to resultsA Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC
Primary Purpose
Advanced Hepatocellular Carcinoma
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ociperlimab
Tislelizumab
BAT1706
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Hepatocellular Carcinoma
Eligibility Criteria
Criteria:
Inclusion Criteria:
- Histologically confirmed HCC
- 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
- Tumor tissue required for an evaluable 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
Sites / Locations
- Cancer Hospital Chinese Academy of Medical Sciences
- Beijing Cancer Hospital
- Chongqing University Three Gorges Hospital
- Fujian Cancer Hospital
- Mengchao Hepatobiliary Hospital of Fujian Medical University
- Guangdong Provincial People's Hospital
- The First Affiliated Hospital, Sun Yat-sen University
- Harbin Medical University Cancer Hospital
- Hubei Cancer Hospital
- Hunan Cancer Hospital
- The First Hospital of China Medical University
- Shengjing Hospital of China Medical University
- Fudan University Zhongshan Hospital
- West China Hospital Sichuan University
- Tianjin Medical University Cancer institute & Hospital
- Tianjin Third Central Hospital
- The Second Affiliated Hospital of Zhejiang University School of Medicine
- Nanfang Hospital of Southern Medical University
- The Second Affiliated Hospital of Nanchang University
- Hwa Mei Hospital, University of Chinese Academy of Sciences
- National Cheng Kung University Hospital
- Chi Mei Medical Center
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Chang Gung Medical Foundation (CGMF) - Linkou Branch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A: ociperlimab + tislelizumab + BAT1706
Arm B: tislelizumab + BAT1706
Arm Description
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
tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR) as assessed by the investigator
defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1
Secondary Outcome Measures
Duration of Response (DOR) as assessed by the investigator
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.
TIme to Response (TTR) as assessed by the investigator
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.
Disease Control Rate (DCR) as assessed by the investigator
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.
Clinical Benefit Rate (CBR)
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)
PFS as assessed by the investigator
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
Overall Survival (OS)
measured time from the date of the first dose of study drug until the date of death from any cause
Incidence and severity of adverse events (AEs),
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
Serum concentrations of ociperlimab at specified timepoints
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
Serum concentrations of tislelizumab at specified timepoints
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
Serum concentrations of BAT1706 at specified timepoints
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
Immunogenic Response to ociperlimab
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
Immunogenic Response to tislelizumab
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
Immunogenic Response to BAT1706
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04948697
Brief Title
A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: ociperlimab + tislelizumab + BAT1706
Arm Type
Experimental
Arm Description
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
Arm Title
Arm B: tislelizumab + BAT1706
Arm Type
Experimental
Arm Description
tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Ociperlimab
Other Intervention Name(s)
BGB-A1217
Intervention Description
900 mg intravenously once every 3 weeks (dosed in 21-day cycles)
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
200 mg intravenously once every 3 weeks (dosed in 21-day cycles)
Intervention Type
Drug
Intervention Name(s)
BAT1706
Other Intervention Name(s)
Bevacizumab Injection
Intervention Description
15 mg/kg intravenously once every 3 weeks (dosed in 21-day cycles)
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) as assessed by the investigator
Description
defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1
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
Secondary Outcome Measure Information:
Title
Duration of Response (DOR) as assessed by the investigator
Description
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.
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
Title
TIme to Response (TTR) as assessed by the investigator
Description
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.
Time Frame
time from the date of first dose of study drug to the first documentation of response, assessed up to 24 months
Title
Disease Control Rate (DCR) as assessed by the investigator
Description
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.
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
Title
Clinical Benefit Rate (CBR)
Description
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)
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
Title
PFS as assessed by the investigator
Description
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
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
Title
Overall Survival (OS)
Description
measured time from the date of the first dose of study drug until the date of death from any cause
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
Title
Incidence and severity of adverse events (AEs),
Description
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
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
Title
Serum concentrations of ociperlimab at specified timepoints
Description
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
Time Frame
Through study completion, up to 24 months
Title
Serum concentrations of tislelizumab at specified timepoints
Description
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
Time Frame
Through study completion, up to 24 months
Title
Serum concentrations of BAT1706 at specified timepoints
Description
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
Time Frame
Through study completion, up to 24 months
Title
Immunogenic Response to ociperlimab
Description
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
Time Frame
Through study completion, up to 24 months
Title
Immunogenic Response to tislelizumab
Description
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
Time Frame
Through study completion, up to 24 months
Title
Immunogenic Response to BAT1706
Description
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
Time Frame
Through study completion, up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria:
Inclusion Criteria:
Histologically confirmed HCC
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
Tumor tissue required for an evaluable 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Li, MD
Organizational Affiliation
BeiGene, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Chongqing University Three Gorges Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Mengchao Hepatobiliary Hospital of Fujian Medical University
City
Gulou
State/Province
Fuzhou
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110022
Country
China
Facility Name
Fudan University Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University Cancer institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300070
Country
China
Facility Name
Tianjin Third Central Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangdong
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Jiangxi
Country
China
Facility Name
Hwa Mei Hospital, University of Chinese Academy of Sciences
City
Zhejiang
Country
China
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Chi Mei Medical Center
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Medical Foundation (CGMF) - Linkou Branch
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC
We'll reach out to this number within 24 hrs