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    Clinical Trial Results:
    Phase 2 Study Investigating Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody BGB-A1217 in Patients With Previously Treated Recurrent or Metastatic Cervical Cancer

    Summary
    EudraCT number
    		 2020-004657-77
    Trial protocol
    		 BG   PL  
    Global end of trial date
    31 Aug 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Sep 2024
    First version publication date
    07 Sep 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BGB-A317-A1217-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04693234
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 CTR20212809: ChinaDrugTrials, CTR20210588: ChinaDrugTrials, AdvanTIG-202: BeiGene
    Sponsors
    Sponsor organisation name
    BeiGene
    Sponsor organisation address
    1840 Gateway Drive, San Mateo, CA , United States, 94404
    Public contact
    BeiGene Clinical Support, BeiGene USA, Inc., 1 877-828-5568, clinicaltrials@beigene.com
    Scientific contact
    BeiGene Clinical Support, BeiGene USA, Inc., 1 877-828-5568, clinicaltrials@beigene.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of BGB-A1217 combined with tislelizumab as measured by ORR according to RECIST v1.1, by Independent Review Committee (IRC) in patients who had previously treated recurrent or metastatic cervical cancer.
    Protection of trial subjects
    This trial was designed and monitored in accordance with Sponsor procedures, which comply with the ethical principles of GCP as required by the major regulatory authorities, and in accordance with the Declaration of Helsinki. The IEC/IRB-approved ICF was signed and dated by the subject or the subject’s legally authorized representative before his or her participation in the study. A copy of each signed ICF was provided to the subject or the subject’s legally authorized representative. All signed and dated ICFs were retained in each patient’s study file or in the site file. For any updated or revised ICFs, written informed consent was obtained using the IEC/IRB-approved updated/revised ICFs for continued participation in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Feb 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Ethical reason
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 88
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 38
    Country: Number of subjects enrolled
    Taiwan: 16
    Country: Number of subjects enrolled
    Ukraine: 10
    Country: Number of subjects enrolled
    Russian Federation: 11
    Country: Number of subjects enrolled
    Thailand: 12
    Country: Number of subjects enrolled
    Bulgaria: 2
    Country: Number of subjects enrolled
    Poland: 1
    Worldwide total number of subjects
    178
    EEA total number of subjects
    3
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    160
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled in multiple study centers in China, South Korea, and Europe. The first patient dosed was on March 3rd, 2021 and the last participant completed on August 31st, 2023.

    Pre-assignment
    Screening details
    		 The study was composed of an initial screening phase (up to 28 days), a treatment phase, an end of treatment visit, an on-site Safety Follow-up Visit, and 2 Safety Follow-up Visits by telephone after the last dose of study treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    None (Open Label)

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: Ociperlimab + Tislelizumab
    Arm description
    		 Tislelizumab 200 milligrams (mg) intravenously (IV) once every 3 weeks (Q3W) combined with ociperlimab (BGB-A1217) 900 mg IV Q3W
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tislelizumab
    Investigational medicinal product code
    Other name
    Tevimbra
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg administered intravenously once every 3 weeks on day 1 of each cycle

    Investigational medicinal product name
    Ociperlimab
    Investigational medicinal product code
    Other name
    BGB-A1217
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    900 mg administered intravenously once every 3 weeks on day 1 of each cycle

    Arm title
    		 Cohort 2: Tislelizumab
    Arm description
    		 Tislelizumab 200 mg IV Q3W monotherapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tislelizumab
    Investigational medicinal product code
    Other name
    Tevimbra
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg administered intravenously once every 3 weeks on day 1 of each cycle

    Number of subjects in period 1
    		Cohort 1: Ociperlimab + Tislelizumab Cohort 2: Tislelizumab
    Started
    138
    40
    Completed
    0
    0
    Not completed
    138
    40
         Consent withdrawn by subject
    10
    2
         Death
    79
    19
         Study Terminated by Sponsor
    47
    18
         Lost to follow-up
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: Ociperlimab + Tislelizumab
    Reporting group description
    		 Tislelizumab 200 milligrams (mg) intravenously (IV) once every 3 weeks (Q3W) combined with ociperlimab (BGB-A1217) 900 mg IV Q3W

    Reporting group title
    Cohort 2: Tislelizumab
    Reporting group description
    		 Tislelizumab 200 mg IV Q3W monotherapy

    Reporting group values
    		 Cohort 1: Ociperlimab + Tislelizumab Cohort 2: Tislelizumab Total
    Number of subjects
    		 138 40 178
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.7 ( 10.28 ) 51.2 ( 9.74 ) -
    Gender categorical
    Units: Subjects
        Female
    		 138 40 178
    Race/Ethnicity
    Units: Subjects
        Asian
    		 117 37 154
        White
    		 21 3 24
    ECOG Performance Status
    Units: Subjects
        ECOG Performance = 0
    		 53 16 69
        ECOG Performance = 1
    		 85 24 109
    PD-L1 Expression
    Units: Subjects
        PD-L1 Score >= 5%
    		 84 20 104
        PD-L1 Score < 5%
    		 53 20 73
        Not Evaluable
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: Ociperlimab + Tislelizumab
    Reporting group description
    		 Tislelizumab 200 milligrams (mg) intravenously (IV) once every 3 weeks (Q3W) combined with ociperlimab (BGB-A1217) 900 mg IV Q3W

    Reporting group title
    Cohort 2: Tislelizumab
    Reporting group description
    		 Tislelizumab 200 mg IV Q3W monotherapy

    Subject analysis set title
    Cohort 1 (Predose)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Pharmacokinetic Analysis Set includes all participants who received >= 1 dose of any component of study drug per the protocol, for whom any post-dose PK data are available. Ociperlimab: 900 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion. Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion

    Subject analysis set title
    Cohort 1 (Postdose)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Pharmacokinetic Analysis Set includes all participants who received >= 1 dose of any component of study drug per the protocol, for whom any post-dose PK data are available. Ociperlimab: 900 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion. Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.

    Subject analysis set title
    Cohort 2 (Predose)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Pharmacokinetic Analysis Set includes all participants who received >= 1 dose of any component of study drug per the protocol, for whom any post-dose PK data are available. Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion

    Subject analysis set title
    Cohort 2 (Postdose)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Pharmacokinetic Analysis Set includes all participants who received >= 1 dose of any component of study drug per the protocol, for whom any post-dose PK data are available. Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.

    Primary: Cohort 1: Objective Response Rate (ORR) as Assessed by an Independent Review Committee (IRC) (PD-L1 Score ≥ 5% Safety Analysis Set)

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    End point title
    		 Cohort 1: Objective Response Rate (ORR) as Assessed by an Independent Review Committee (IRC) (PD-L1 Score ≥ 5% Safety Analysis Set) [1] [2]
    End point description
    Defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the IRC per RECIST v1.1 in the PD-L1 Score ≥ 5% Safety Analysis Set. The PD-L1 Score >= 5% Safety Analysis Set includes all treated participants whose tumors have PD-L1 Score >= 5%.
    End point type
    Primary
    End point timeframe
    Up to approximately 2 years and 6 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Not estimable due to insufficient number of participants with events
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not estimable due to insufficient number of participants with events
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab
    Number of subjects analysed
    84
    Units: Percentage of Participants
        number (confidence interval 95%)
    27.4 (18.2 to 38.2)
    No statistical analyses for this end point

    Primary: Cohort 1: ORR as Assessed by an IRC (Safety Analysis Set)

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    End point title
    		 Cohort 1: ORR as Assessed by an IRC (Safety Analysis Set) [3] [4]
    End point description
    Defined as the percentage of participants who had CR or PR as assessed by the IRC per RECIST v1.1 in the safety analysis set. The Safety Analysis Set is defined as all participants who received >= 1 dose of any study drug for each cohort.
    End point type
    Primary
    End point timeframe
    Up to approximately 2 years and 6 months
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Not estimable due to insufficient number of participants with events
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not estimable due to insufficient number of participants with events
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab
    Number of subjects analysed
    138
    Units: percentage of participants
        number (confidence interval 95%)
    23.2 (16.4 to 31.1)
    No statistical analyses for this end point

    Secondary: Cohort 1: ORR as Assessed by an Investigator’s Review (PD-L1 Score ≥ 5% Safety Analysis Set)

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    End point title
    		 Cohort 1: ORR as Assessed by an Investigator’s Review (PD-L1 Score ≥ 5% Safety Analysis Set) [5]
    End point description
    Defined as the percentage of participants who had CR or PR as assessed by the investigator per RECIST v1.1 in the PD-L1 Score >= 5% Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    Up to approximately 2 years and 6 months
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not estimable due to insufficient number of participants with events
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab
    Number of subjects analysed
    84
    Units: percentage of participants
        number (confidence interval 95%)
    26.2 (17.2 to 36.9)
    No statistical analyses for this end point

    Secondary: Cohort 1: ORR as Assessed by an Investigator’s Review (Safety Analysis Set)

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    End point title
    		 Cohort 1: ORR as Assessed by an Investigator’s Review (Safety Analysis Set) [6]
    End point description
    Defined as the percentage of participants who had CR or PR as assessed by the investigator per RECIST v1.1 in the Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    Up to approximately 2 years and 6 months
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not estimable due to insufficient number of participants with events
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab
    Number of subjects analysed
    138
    Units: percentage of participants
        number (confidence interval 95%)
    21.7 (15.2 to 29.6)
    No statistical analyses for this end point

    Secondary: Cohort 2: ORR (PD-L1 Score >= 5% Safety Analysis Set)

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    End point title
    		 Cohort 2: ORR (PD-L1 Score >= 5% Safety Analysis Set) [7]
    End point description
    Defined as the percentage of participants who had CR or PR as assessed by the IRC per RECIST v1.1 as assessed by an IRC and investigator's review in the PD-L1 Score >= 5% Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    Up to approximately 2 years and 6 months
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not estimable due to insufficient number of participants with events
    End point values
    		 Cohort 2: Tislelizumab
    Number of subjects analysed
    20
    Units: percentage of participants
    number (confidence interval 95%)
        IRC
    35.0 (15.4 to 59.2)
        Investigator
    30.0 (11.9 to 54.3)
    No statistical analyses for this end point

    Secondary: Cohort 2: ORR (Safety Analysis Set)

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    End point title
    		 Cohort 2: ORR (Safety Analysis Set) [8]
    End point description
    Defined as the percentage of participants who had CR or PR as assessed by the IRC per RECIST v1.1 as assessed by an IRC and investigator's review in the Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    Up to approximately 2 years and 6 months
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not estimable due to insufficient number of participants with events
    End point values
    		 Cohort 2: Tislelizumab
    Number of subjects analysed
    40
    Units: percentage of participants
    number (confidence interval 95%)
        IRC
    35.0 (20.6 to 51.7)
        Investigator
    25.0 (12.7 to 41.2)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    Defined as the time from the first confirmed objective response until the first documentation of progression or death, whichever comes first, assessed by both IRC and investigator’s review according to RECIST v1.1 in the Safety Analysis Set. Data are based on number of responders. Due to EudraCT system limitations, the IRC category includes 32 respondents in Cohort 1 (C1) and 14 in Cohort 2 (C2). In the investigator category, there are 30 respondents in C1 and 10 in C2.
    End point type
    Secondary
    End point timeframe
    Up to approximately 2 years and 6 months
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab Cohort 2: Tislelizumab
    Number of subjects analysed
    138
    40
    Units: Months
    median (confidence interval 95%)
        IRC (32 in C1, 14 in C2)
    17.3 (16.9 to 9999)
    9999 (4.6 to 9999)
        Investigator (30 in C1, 10 in C2)
    15.5 (6.9 to 9999)
    9999 (5.5 to 9999)
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    defined as the time from the date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first as assessed by both IRC and investigator's review per RECIST v1.1 in the Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    Up to approximately 2 years and 6 months
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab Cohort 2: Tislelizumab
    Number of subjects analysed
    138
    40
    Units: Months
    median (confidence interval 95%)
        IRC
    3.0 (2.6 to 4.9)
    5.7 (2.3 to 8.1)
        Investigator
    3.9 (2.6 to 4.4)
    5.7 (2.6 to 9.2)
    No statistical analyses for this end point

    Secondary: Time to Response (TTR)

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    End point title
    		 Time to Response (TTR)
    End point description
    defined as the time from the date of first dose of study drug to first documentation of response as assessed by both IRC and investigator's review per RECIST v1.1 in the Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    Up to the primary analysis data cut off point (approximately 16 months)
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab Cohort 2: Tislelizumab
    Number of subjects analysed
    138
    40
    Units: Weeks
    arithmetic mean (standard deviation)
        IRC
    9.02 ( 4.704 )
    11.78 ( 4.709 )
        Investigator
    10.66 ( 5.010 )
    8.92 ( 3.174 )
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR)

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    End point title
    		 Disease Control Rate (DCR)
    End point description
    defined as the proportion of participants who achieve CR, PR, or stable disease (SD) as assessed by both IRC and investigator's review per RECIST v1.1 in the Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    Up to approximately 2 years and 6 months
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab Cohort 2: Tislelizumab
    Number of subjects analysed
    138
    40
    Units: percentage of participants
    number (confidence interval 95%)
        IRC
    63.0 (54.4 to 71.1)
    67.5 (50.9 to 81.4)
        Investigator
    62.3 (53.7 to 70.4)
    75.0 (58.8 to 87.3)
    No statistical analyses for this end point

    Secondary: Clinical Benefit Rate (CBR)

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    End point title
    		 Clinical Benefit Rate (CBR)
    End point description
    defined as the percentage of participants who achieve CR, PR, or durable SD (SD ≥ 24 weeks) as assessed by both IRC and investigator's review per RECIST v1.1 in the Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    Up to approximately 2 years and 6 months
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab Cohort 2: Tislelizumab
    Number of subjects analysed
    138
    40
    Units: percentage of participants
    number (confidence interval 95%)
        IRC
    29.0 (21.6 to 37.3)
    50.0 (33.8 to 66.2)
        Investigator
    31.2 (23.6 to 39.6)
    50.0 (33.8 to 66.2)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    defined as the time from the date of first dose of study drug until the date of death from any cause in the Safety Analysis Set.
    End point type
    Secondary
    End point timeframe
    Up to approximately 2 years and 6 months
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab Cohort 2: Tislelizumab
    Number of subjects analysed
    138
    40
    Units: Months
        median (confidence interval 95%)
    12.2 (9.9 to 16.6)
    23.5 (13.6 to 9999)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning Score

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    End point title
    		 Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning Score
    End point description
    The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).
    End point type
    Secondary
    End point timeframe
    Baseline to Cycle 15 (21 days per cycle)
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab Cohort 2: Tislelizumab
    Number of subjects analysed
    138
    40
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    78.91 ( 19.211 )
    76.67 ( 22.501 )
        Change at Cycle 15
    23.33 ( 4.714 )
    7.33 ( 18.974 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Index Score.

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    End point title
    		 Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Index Score.
    End point description
    The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and/or treatments. The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual/ vaginal functioning. The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment. The change from baseline in EORTC QLQ-CX24 score will be presented.
    End point type
    Secondary
    End point timeframe
    Baseline to Cycle 15 (21 days per cycle)
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab Cohort 2: Tislelizumab
    Number of subjects analysed
    138
    40
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Baseline
    30.86 ( 6.942 )
    31.43 ( 4.497 )
        Change at Cycle 15
    -2.59 ( 11.313 )
    0.84 ( 4.196 )
    No statistical analyses for this end point

    Secondary: Number of Participants Experiencing Adverse Events (AEs)

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    End point title
    		 Number of Participants Experiencing Adverse Events (AEs)
    End point description
    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) characterized by type, frequency, severity (as graded by National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 [NCICTCAE v5.0]), timing, seriousness, and relationship to study drugs, physical examinations, electrocardiograms (ECGs), and laboratory assessments
    End point type
    Secondary
    End point timeframe
    From the date of the first dose of study drug(s) through 30 days after the last dose or the initiation of new anti-cancer therapy, whichever is earlier; up to approximately 2 years and 6 months
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab Cohort 2: Tislelizumab
    Number of subjects analysed
    138
    40
    Units: Participants
        Number of Participants with at least one TEAE
    135
    39
        Number of participants with at least one SAE
    61
    17
    No statistical analyses for this end point

    Secondary: Serum Ociperlimab (BGB-A1217) Concentrations at Specified Timepoints

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    End point title
    		 Serum Ociperlimab (BGB-A1217) Concentrations at Specified Timepoints
    End point description
    The timepoints are defined as predose (within 60 minutes before starting infusion) and postdose (within 30 minutes after the end of infusion). The Pharmacokinetic Analysis Set includes all participants who received >= 1 dose of any component of study drug per the protocol, for whom any post-dose PK data are available.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycles 1, 2, 5, 9, and 17 (each cycle is 21 days)
    End point values
    		 Cohort 1 (Predose) Cohort 1 (Postdose)
    Number of subjects analysed
    138
    Units: Concentrations (μg/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 1 Day 1
    0000 ( 0000 )
    363.19 ( 24.21 )
        Cycle 2 Day 1
    46.60 ( 46.98 )
    0000 ( 0000 )
        Cycle 5 Day 1
    82.57 ( 55.30 )
    440.70 ( 25.35 )
        Cycle 9 Day 1
    89.13 ( 56.58 )
    0000 ( 0000 )
        Cycle 17 Day 1
    88.84 ( 63.62 )
    0000 ( 0000 )
    No statistical analyses for this end point

    Secondary: Serum Tislelizumab Concentrations at Specified Timepoints

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    End point title
    		 Serum Tislelizumab Concentrations at Specified Timepoints
    End point description
    The timepoints are defined as predose (within 60 minutes before starting infusion) and postdose (within 30 minutes after the end of infusion). The Pharmacokinetic Analysis Set includes all participants who received >= 1 dose of any component of study drug per the protocol, for whom any post-dose PK data are available.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycles 1, 2, 5, 9, and 17 (each cycle is 21 days)
    End point values
    		 Cohort 1 (Predose) Cohort 1 (Postdose) Cohort 2 (Predose) Cohort 2 (Postdose)
    Number of subjects analysed
    Units: Concentrations (μg/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 1 Day 1
    0000 ( 0000 )
    77.38 ( 21.78 )
    0000 ( 0000 )
    84.24 ( 18.19 )
        Cycle 2 Day 1
    17.86 ( 35.69 )
    0000 ( 0000 )
    20.03 ( 36.62 )
    0000 ( 0000 )
        Cycle 5 Day 1
    36.66 ( 44.97 )
    113.80 ( 24.68 )
    41.51 ( 42.89 )
    128.48 ( 24.06 )
        Cycle 9 Day 1
    42.84 ( 46.50 )
    0000 ( 0000 )
    56.78 ( 28.55 )
    0000 ( 0000 )
        Cycle 17 Day 1
    45.16 ( 55.71 )
    0000 ( 0000 )
    56.25 ( 21.56 )
    0000 ( 0000 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Postive Anti-drug Antibodies (ADAs) to Ociperlimab

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    End point title
    		 Number of Participants With Postive Anti-drug Antibodies (ADAs) to Ociperlimab [9]
    End point description
    Number and percentage of participants who develop detectable ADAs. The ADA Analysis Set includes all participants who received at least 1 dose of any component of study drug for whom both baseline antidrug antibody result and at least 1 post-baseline antidrug antibody result are available.
    End point type
    Secondary
    End point timeframe
    Baseline and up to approximately 2 years and 6 months
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not estimable due to insufficient number of participants with events
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab
    Number of subjects analysed
    127
    Units: participants
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Positive Anti-drug Antibodies (ADAs) to Tislelizumab

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    End point title
    		 Number of Participants With Positive Anti-drug Antibodies (ADAs) to Tislelizumab
    End point description
    Number and percentage of participants who develop detectable ADAs. The ADA Analysis Set includes all participants who received at least 1 dose of any component of study drug for whom both baseline antidrug antibody result and at least 1 post-baseline antidrug antibody result are available.
    End point type
    Secondary
    End point timeframe
    Baseline and up to approximately 2 years and 6 months
    End point values
    		 Cohort 1: Ociperlimab + Tislelizumab Cohort 2: Tislelizumab
    Number of subjects analysed
    127
    39
    Units: participants
    19
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the date of the first dose of study drug(s) through 30 days after the last dose or the initiation of new anti-cancer therapy, whichever is earlier; up to approximately 2 years and 6 months
    Adverse event reporting additional description
    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) characterized by type, frequency, severity (as graded by NCICTCAE v5.0), timing, seriousness, and relationship to study drugs, physical examinations, ECGs, and laboratory assessments.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Cohort 2: Tislelizumab
    Reporting group description
    		 Cohort 2: Tislelizumab

    Reporting group title
    Cohort 1: Ociperlimab + Tislelizumab
    Reporting group description
    		 Cohort 1: Ociperlimab + Tislelizumab

    Serious adverse events
    		 Cohort 2: Tislelizumab Cohort 1: Ociperlimab + Tislelizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 40 (42.50%)
    61 / 138 (44.20%)
         number of deaths (all causes)
    19
    79
         number of deaths resulting from adverse events
    4
    13
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to central nervous system
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tumour thrombosis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vena cava thrombosis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 40 (5.00%)
    5 / 138 (3.62%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 40 (0.00%)
    4 / 138 (2.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    General physical health deterioration
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Death
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Reproductive system and breast disorders
    Female genital tract fistula
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital swelling
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonitis
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 40 (0.00%)
    4 / 138 (2.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated lung disease
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Dyspnoea
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Blood creatinine increased
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Atrial thrombosis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral ischaemia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 40 (0.00%)
    4 / 138 (2.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    2 / 40 (5.00%)
    3 / 138 (2.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal adhesions
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctalgia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vomiting
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urogenital fistula
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertonic bladder
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    3 / 40 (7.50%)
    4 / 138 (2.90%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Acute hepatitis C
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    3 / 40 (7.50%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal abscess
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 40 (5.00%)
    11 / 138 (7.97%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Cohort 2: Tislelizumab Cohort 1: Ociperlimab + Tislelizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 40 (92.50%)
    128 / 138 (92.75%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    0
    Vascular disorders
    Lymphoedema
         subjects affected / exposed
    1 / 40 (2.50%)
    5 / 138 (3.62%)
         occurrences all number
    1
    5
    Hypertension
         subjects affected / exposed
    2 / 40 (5.00%)
    5 / 138 (3.62%)
         occurrences all number
    2
    7
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    3 / 40 (7.50%)
    2 / 138 (1.45%)
         occurrences all number
    3
    2
    Malaise
         subjects affected / exposed
    1 / 40 (2.50%)
    6 / 138 (4.35%)
         occurrences all number
    2
    6
    Oedema peripheral
         subjects affected / exposed
    1 / 40 (2.50%)
    6 / 138 (4.35%)
         occurrences all number
    1
    7
    Pyrexia
         subjects affected / exposed
    7 / 40 (17.50%)
    27 / 138 (19.57%)
         occurrences all number
    7
    38
    Fatigue
         subjects affected / exposed
    2 / 40 (5.00%)
    8 / 138 (5.80%)
         occurrences all number
    2
    10
    Asthenia
         subjects affected / exposed
    3 / 40 (7.50%)
    8 / 138 (5.80%)
         occurrences all number
    6
    12
    Chills
         subjects affected / exposed
    1 / 40 (2.50%)
    11 / 138 (7.97%)
         occurrences all number
    1
    11
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 40 (2.50%)
    8 / 138 (5.80%)
         occurrences all number
    3
    9
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 40 (5.00%)
    13 / 138 (9.42%)
         occurrences all number
    2
    15
    Dyspnoea
         subjects affected / exposed
    0 / 40 (0.00%)
    6 / 138 (4.35%)
         occurrences all number
    0
    6
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 40 (7.50%)
    5 / 138 (3.62%)
         occurrences all number
    3
    5
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 40 (10.00%)
    16 / 138 (11.59%)
         occurrences all number
    5
    24
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 40 (12.50%)
    24 / 138 (17.39%)
         occurrences all number
    6
    35
    Blood alkaline phosphatase increased
         subjects affected / exposed
    3 / 40 (7.50%)
    12 / 138 (8.70%)
         occurrences all number
    3
    14
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 40 (7.50%)
    4 / 138 (2.90%)
         occurrences all number
    3
    4
    Blood creatinine increased
         subjects affected / exposed
    6 / 40 (15.00%)
    16 / 138 (11.59%)
         occurrences all number
    6
    25
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    4 / 40 (10.00%)
    2 / 138 (1.45%)
         occurrences all number
    4
    4
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    5 / 40 (12.50%)
    0 / 138 (0.00%)
         occurrences all number
    5
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    2 / 40 (5.00%)
    4 / 138 (2.90%)
         occurrences all number
    2
    4
    Blood urea increased
         subjects affected / exposed
    0 / 40 (0.00%)
    5 / 138 (3.62%)
         occurrences all number
    0
    5
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 40 (5.00%)
    3 / 138 (2.17%)
         occurrences all number
    2
    3
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 40 (2.50%)
    7 / 138 (5.07%)
         occurrences all number
    1
    9
    Neutrophil count decreased
         subjects affected / exposed
    5 / 40 (12.50%)
    6 / 138 (4.35%)
         occurrences all number
    15
    10
    Thyroxine free increased
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    0
    Weight decreased
         subjects affected / exposed
    4 / 40 (10.00%)
    18 / 138 (13.04%)
         occurrences all number
    5
    22
    Weight increased
         subjects affected / exposed
    2 / 40 (5.00%)
    3 / 138 (2.17%)
         occurrences all number
    2
    4
    White blood cell count decreased
         subjects affected / exposed
    4 / 40 (10.00%)
    13 / 138 (9.42%)
         occurrences all number
    15
    26
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 40 (5.00%)
    9 / 138 (6.52%)
         occurrences all number
    2
    10
    Hypoaesthesia
         subjects affected / exposed
    2 / 40 (5.00%)
    3 / 138 (2.17%)
         occurrences all number
    2
    3
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 138 (0.72%)
         occurrences all number
    2
    1
    Anaemia
         subjects affected / exposed
    15 / 40 (37.50%)
    48 / 138 (34.78%)
         occurrences all number
    23
    66
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 40 (15.00%)
    9 / 138 (6.52%)
         occurrences all number
    7
    11
    Abdominal pain lower
         subjects affected / exposed
    0 / 40 (0.00%)
    9 / 138 (6.52%)
         occurrences all number
    0
    15
    Diarrhoea
         subjects affected / exposed
    2 / 40 (5.00%)
    15 / 138 (10.87%)
         occurrences all number
    4
    18
    Constipation
         subjects affected / exposed
    3 / 40 (7.50%)
    18 / 138 (13.04%)
         occurrences all number
    3
    20
    Abdominal pain upper
         subjects affected / exposed
    1 / 40 (2.50%)
    9 / 138 (6.52%)
         occurrences all number
    1
    9
    Vomiting
         subjects affected / exposed
    3 / 40 (7.50%)
    17 / 138 (12.32%)
         occurrences all number
    3
    22
    Toothache
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 138 (0.00%)
         occurrences all number
    3
    0
    Stomatitis
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 138 (0.72%)
         occurrences all number
    2
    1
    Nausea
         subjects affected / exposed
    6 / 40 (15.00%)
    27 / 138 (19.57%)
         occurrences all number
    7
    34
    Flatulence
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 138 (0.00%)
         occurrences all number
    3
    0
    Dyspepsia
         subjects affected / exposed
    1 / 40 (2.50%)
    5 / 138 (3.62%)
         occurrences all number
    1
    6
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 138 (0.72%)
         occurrences all number
    3
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    5 / 40 (12.50%)
    15 / 138 (10.87%)
         occurrences all number
    7
    18
    Rash
         subjects affected / exposed
    3 / 40 (7.50%)
    18 / 138 (13.04%)
         occurrences all number
    3
    18
    Urticaria
         subjects affected / exposed
    2 / 40 (5.00%)
    5 / 138 (3.62%)
         occurrences all number
    2
    6
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    3 / 40 (7.50%)
    4 / 138 (2.90%)
         occurrences all number
    4
    4
    Proteinuria
         subjects affected / exposed
    0 / 40 (0.00%)
    6 / 138 (4.35%)
         occurrences all number
    0
    6
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    8 / 40 (20.00%)
    27 / 138 (19.57%)
         occurrences all number
    9
    28
    Hyperthyroidism
         subjects affected / exposed
    3 / 40 (7.50%)
    4 / 138 (2.90%)
         occurrences all number
    3
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 40 (2.50%)
    5 / 138 (3.62%)
         occurrences all number
    1
    5
    Back pain
         subjects affected / exposed
    1 / 40 (2.50%)
    14 / 138 (10.14%)
         occurrences all number
    1
    15
    Flank pain
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 138 (1.45%)
         occurrences all number
    5
    2
    Muscular weakness
         subjects affected / exposed
    3 / 40 (7.50%)
    2 / 138 (1.45%)
         occurrences all number
    3
    2
    Myalgia
         subjects affected / exposed
    3 / 40 (7.50%)
    5 / 138 (3.62%)
         occurrences all number
    3
    5
    Pain in extremity
         subjects affected / exposed
    0 / 40 (0.00%)
    7 / 138 (5.07%)
         occurrences all number
    0
    7
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3 / 40 (7.50%)
    10 / 138 (7.25%)
         occurrences all number
    3
    11
    Urinary tract infection
         subjects affected / exposed
    10 / 40 (25.00%)
    16 / 138 (11.59%)
         occurrences all number
    11
    18
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 40 (20.00%)
    15 / 138 (10.87%)
         occurrences all number
    12
    20
    Hyperglycaemia
         subjects affected / exposed
    1 / 40 (2.50%)
    5 / 138 (3.62%)
         occurrences all number
    2
    5
    Hyperlipidaemia
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 138 (1.45%)
         occurrences all number
    9
    2
    Hyperuricaemia
         subjects affected / exposed
    0 / 40 (0.00%)
    6 / 138 (4.35%)
         occurrences all number
    0
    6
    Hypoalbuminaemia
         subjects affected / exposed
    4 / 40 (10.00%)
    25 / 138 (18.12%)
         occurrences all number
    5
    33
    Hypocalcaemia
         subjects affected / exposed
    1 / 40 (2.50%)
    12 / 138 (8.70%)
         occurrences all number
    1
    15
    Hypokalaemia
         subjects affected / exposed
    8 / 40 (20.00%)
    20 / 138 (14.49%)
         occurrences all number
    10
    40
    Hypomagnesaemia
         subjects affected / exposed
    2 / 40 (5.00%)
    12 / 138 (8.70%)
         occurrences all number
    2
    18
    Hyponatraemia
         subjects affected / exposed
    2 / 40 (5.00%)
    8 / 138 (5.80%)
         occurrences all number
    2
    8
    Hypophosphataemia
         subjects affected / exposed
    0 / 40 (0.00%)
    5 / 138 (3.62%)
         occurrences all number
    0
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Sep 2020
    Original Protocol
    04 May 2023
    Protocol Amendment 0.1 (Russia)

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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