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    Clinical Trial Results:
    A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

    Summary
    EudraCT number
    		 2020-004658-32
    Trial protocol
    		 FR   ES  
    Global end of trial date
    26 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jan 2025
    First version publication date
    08 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BGB-A317-A1217-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04732494
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 ChinaDrugTrials.org: CTR20213241/CTR20210243, BeiGene: AdvanTIG-203
    Sponsors
    Sponsor organisation name
    BeiGene
    Sponsor organisation address
    1840 Gateway Drive, San Mateo, CA, United States, 94404
    Public contact
    Clinical Trial Information Email, BeiGene USA, Inc., 1 877-828-5568, ClinicalTrials@beigene.com
    Scientific contact
    Clinical Trial Information Email, 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
    26 Dec 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), of tislelizumab plus ociperlimab with tislelizumab plus placebo as second-line treatment in patients with programmed cell death ligand-1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
    Protection of trial subjects
    This study was conducted in accordance with BeiGene, Ltd. (BeiGene) procedures, which comply with the principles of Good Clinical Practice, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, the Declaration of Helsinki, and applicable local regulatory requirements. The protocol, protocol amendments, and informed consent forms (ICFs) were reviewed and approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB) in conformance with Good Clinical Practice and applicable regulatory requirements. The IEC/IRB-approved ICF was signed and dated by the patient or the patient’s legally authorized representative before his or her participation in the study. A copy of each signed ICF was provided to the patient or the patient’s legally authorized representative.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 73
    Country: Number of subjects enrolled
    Korea, Republic of: 14
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    Taiwan: 20
    Country: Number of subjects enrolled
    Thailand: 4
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    France: 6
    Worldwide total number of subjects
    125
    EEA total number of subjects
    13
    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)
    67
    From 65 to 84 years
    58
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 52 study centers in 7 countries (Chinese mainland, Chinese Taiwan, South Korea, Thailand, France, Spain, and Russia).

    Pre-assignment
    Screening details
    		 Participants were randomized equally to one of two treatment groups. Randomization was stratified by Eastern Cooperative Oncology Group Performance Status (ECOG PS) score (0 versus 1), number of organs with metastases (≤ 1 versus ≥ 2), and region (Asia versus non-Asia).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A: Tislelizumab Plus Ociperlimab
    Arm description
    		 Participants received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tislelizumab
    Investigational medicinal product code
    BGB-A317
    Other name
    TEVIMBRA®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg administered intravenously once every 3 weeks

    Investigational medicinal product name
    Ociperlimab
    Investigational medicinal product code
    BGB-A1217
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    900 mg administered intravenously once every 3 weeks

    Arm title
    		 Arm B: Tislelizumab Plus Placebo
    Arm description
    		 Participants received 200 mg tislelizumab and placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tislelizumab
    Investigational medicinal product code
    BGB-A317
    Other name
    TEVIMBRA®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg administered intravenously once every 3 weeks

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered intravenously once every 3 weeks

    Number of subjects in period 1
    		Arm A: Tislelizumab Plus Ociperlimab Arm B: Tislelizumab Plus Placebo
    Started
    62
    63
    Received Treatment
    62
    63
    Completed
    0
    0
    Not completed
    62
    63
         Study Closed by Sponsor
    20
    15
         Consent withdrawn by subject
    2
    7
         Death
    39
    36
         Lost to follow-up
    1
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A: Tislelizumab Plus Ociperlimab
    Reporting group description
    		 Participants received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

    Reporting group title
    Arm B: Tislelizumab Plus Placebo
    Reporting group description
    		 Participants received 200 mg tislelizumab and placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

    Reporting group values
    		 Arm A: Tislelizumab Plus Ociperlimab Arm B: Tislelizumab Plus Placebo Total
    Number of subjects
    		 62 63 125
    Age categorical
    Units: Subjects
        Between 18 and 65 years
    		 40 27 67
        >=65 years
    		 22 36 58
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.4 ( 7.31 ) 63.6 ( 7.33 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 10 14
        Male
    		 58 53 111
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1
        Asian
    		 56 54 110
        White
    		 3 5 8
        Not Reported
    		 3 3 6
    Eastern Cooperative Oncology Group Performance Status (ECOG PS)
    ECOG Performance Status is used to assess a patient's disease status, and how the disease affects daily living activities according to the following scale: 0 = Fully active, able to carry out all activities without restriction; 1= Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2= Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about > 50% of waking hours; 3= Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4= Completely disabled, confined to bed or chair.
    Units: Subjects
        0 (Fully active)
    		 16 15 31
        1 (Restricted but ambulatory)
    		 46 48 94
    Number of Organs With Metastases
    Units: Subjects
        ≤ 1 organ
    		 32 33 65
        ≥ 2 organs
    		 30 30 60
    Region
    Units: Subjects
        Asia
    		 54 54 108
        Non-Asia
    		 8 9 17

    End points

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    End points reporting groups
    Reporting group title
    Arm A: Tislelizumab Plus Ociperlimab
    Reporting group description
    		 Participants received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

    Reporting group title
    Arm B: Tislelizumab Plus Placebo
    Reporting group description
    		 Participants received 200 mg tislelizumab and placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

    Primary: Objective Response Rate (ORR) Assessed by the Investigator

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    End point title
    		 Objective Response Rate (ORR) Assessed by the Investigator
    End point description
    ORR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) assessed by the Investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Response evaluations were performed using computed tomography or magnetic resonance imaging (MRI) approximately every 6 weeks for the first 54 weeks and every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) < 10 mm, and no new lesions. PR: At least 30% decrease in the size of target lesions, no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of ≥ 1 non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions. CR/PR must have been confirmed ≥ 4 weeks after response was first observed. The Intent-to-Treat (ITT) Analysis Set included all randomized participants.
    End point type
    Primary
    End point timeframe
    Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
    End point values
    		 Arm A: Tislelizumab Plus Ociperlimab Arm B: Tislelizumab Plus Placebo
    Number of subjects analysed
    62
    63
    Units: percentage of participants
        number (confidence interval 95%)
    30.6 (19.6 to 43.7)
    20.6 (11.5 to 32.7)
    Statistical analysis title
    		 Primary Analysis of ORR
    Statistical analysis description
    A Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score [0 vs 1] and number of organs with metastases [≤ 1 vs ≥ 2]) was estimated, along with its 95% confidence interval constructed by a normal approximation and Sato's variance estimator.
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.2114 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Stratified Risk Difference
    Point estimate
    9.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.4
         upper limit
    		 25.3
    Notes
    [1] - The primary endpoint ORR was tested at a 2-sided alpha of 0.05.
    [2] - Cochran-Mantel-Haenszel method stratified by the stratification factors (ECOG PS score [0 vs 1] and number of organs with metastases [≤ 1 vs ≥ 2]).

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall survival (OS) is defined as the time from the date of randomization until the date of death due to any cause. Median overall survival was estimated using the Kaplan-Meier method. For participants who were still alive at the end of the trial, OS was censored at the last known alive date or the date of data cutoff, whichever was earlier.
    End point type
    Secondary
    End point timeframe
    From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B.
    End point values
    		 Arm A: Tislelizumab Plus Ociperlimab Arm B: Tislelizumab Plus Placebo
    Number of subjects analysed
    62
    63
    Units: months
        median (confidence interval 95%)
    10.2 (7.9 to 19.5)
    9.3 (6.4 to 14.8)
    Statistical analysis title
    		 Analysis of OS
    Statistical analysis description
    Hazard ratio and 95% confidence intervals (CIs) were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score [0 vs 1] and the number of organs with metastases [≤ 1 vs ≥ 2]).
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 1.45

    Secondary: Objective Response Rate Assessed by the Independent Review Committee

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    End point title
    		 Objective Response Rate Assessed by the Independent Review Committee
    End point description
    ORR is defined as the percentage of participants who had a best overall response of confirmed complete response (CR) or partial response (PR) assessed by the Independent Review Committee (IRC) according to RECIST v1.1. Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) < 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. Response (CR or PR) must have been confirmed 4 weeks or later after the first response was observed.
    End point type
    Secondary
    End point timeframe
    Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
    End point values
    		 Arm A: Tislelizumab Plus Ociperlimab Arm B: Tislelizumab Plus Placebo
    Number of subjects analysed
    62
    63
    Units: percentage of participants
        number (confidence interval 95%)
    32.3 (20.9 to 45.3)
    25.4 (15.3 to 37.9)
    Statistical analysis title
    		 Analysis of ORR per IRC
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Stratified Risk Difference
    Point estimate
    6.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.2
         upper limit
    		 22.5

    Secondary: Progression-free Survival (PFS) Assessed by the Independent Review Committee

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    End point title
    		 Progression-free Survival (PFS) Assessed by the Independent Review Committee
    End point description
    Progression-free survival is defined as the time from the date of randomization to the date of first documentation of progressive disease assessed by the Independent Review Committee per RECIST v1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions.
    End point type
    Secondary
    End point timeframe
    From randomization up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
    End point values
    		 Arm A: Tislelizumab Plus Ociperlimab Arm B: Tislelizumab Plus Placebo
    Number of subjects analysed
    62
    63
    Units: months
        median (confidence interval 95%)
    3.6 (2.7 to 5.1)
    2.8 (1.9 to 6.9)
    Statistical analysis title
    		 Analysis of PFS per IRC
    Statistical analysis description
    Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score [0 vs 1] and the number of organs with metastases [≤ 1 vs ≥ 2]).
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.59

    Secondary: Progression-free Survival (PFS) Assessed by the Investigator

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    End point title
    		 Progression-free Survival (PFS) Assessed by the Investigator
    End point description
    Progression-free survival is defined as the time from the date of randomization to the date of first documentation of progressive disease assessed by the Investigator per RECIST v1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions.
    End point type
    Secondary
    End point timeframe
    From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B.
    End point values
    		 Arm A: Tislelizumab Plus Ociperlimab Arm B: Tislelizumab Plus Placebo
    Number of subjects analysed
    62
    63
    Units: months
        median (confidence interval 95%)
    3.4 (1.8 to 5.1)
    3.4 (1.9 to 4.1)
    Statistical analysis title
    		 Analysis of OS by Investigator
    Statistical analysis description
    Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score [0 vs 1] and the number of organs with metastases [≤ 1 vs ≥ 2]).
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.61

    Secondary: Duration Of Response (DOR) Assessed by the Independent Review Committee

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    End point title
    		 Duration Of Response (DOR) Assessed by the Independent Review Committee
    End point description
    Duration of response is defined as the time from the first determination of an objective response (CR or PR) until the first documentation of progressive disease as assessed by the Independent Review Committee per RECIST v1.1, or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. The analysis includes participants in the Intent-to-Treat Analysis Set who had an objective response per IRC assessment. "99999" indicates values that could not be estimated due to the low number of events.
    End point type
    Secondary
    End point timeframe
    From randomization up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
    End point values
    		 Arm A: Tislelizumab Plus Ociperlimab Arm B: Tislelizumab Plus Placebo
    Number of subjects analysed
    20
    16
    Units: months
        median (confidence interval 95%)
    14.6 (7.2 to 99999)
    99999 (4.2 to 99999)
    No statistical analyses for this end point

    Secondary: Duration Of Response (DOR) Assessed by the Investigator

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    End point title
    		 Duration Of Response (DOR) Assessed by the Investigator
    End point description
    Duration of response is defined as the time from the first determination of an objective response (CR or PR) until the first documentation of progressive disease as assessed by the Investigator per RECIST v1.1, or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. The analysis includes participants in the Intent-to-Treat Analysis Set who had an objective response per Investigator assessment. "99999" indicates values that could not be estimated due to the low number of events.
    End point type
    Secondary
    End point timeframe
    From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B.
    End point values
    		 Arm A: Tislelizumab Plus Ociperlimab Arm B: Tislelizumab Plus Placebo
    Number of subjects analysed
    19
    14
    Units: months
        median (confidence interval 95%)
    11.3 (5.7 to 99999)
    99999 (4.1 to 99999)
    No statistical analyses for this end point

    Secondary: Disease Control Rate Assessed by the IRC And the Investigator

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    End point title
    		 Disease Control Rate Assessed by the IRC And the Investigator
    End point description
    Disease Control Rate is defined as the percentage of participants who had confirmed CR, PR, or stable disease (SD) assessed by the IRC and the investigator per RECIST v1.1. Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) < 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. SD: Neither sufficient shrinkage in size of lesions to qualify for PR nor sufficient increase to qualify for PD, and no new lesions. Response (CR or PR) must have been confirmed 4 weeks or later after the first response.
    End point type
    Secondary
    End point timeframe
    Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
    End point values
    		 Arm A: Tislelizumab Plus Ociperlimab Arm B: Tislelizumab Plus Placebo
    Number of subjects analysed
    62
    63
    Units: Percentage of participants
    number (confidence interval 95%)
        Investigator assessment
    61.3 (48.1 to 73.4)
    58.7 (45.6 to 71.0)
        Independent Review Committee
    64.5 (51.3 to 76.3)
    58.7 (45.6 to 71.0)
    Statistical analysis title
    		 Analysis of DCR Assessed by the Investigator
    Statistical analysis description
    Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score [0 vs 1] and number of organs with metastases [≤ 1 vs ≥ 2]).
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Stratified Risk Difference
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.4
         upper limit
    		 19.9
    Statistical analysis title
    		 Analysis of DCR Assessed by the IRC
    Statistical analysis description
    Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score [0 vs 1] and number of organs with metastases [≤ 1 vs ≥ 2]).
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Stratified Risk Difference
    Point estimate
    5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.7
         upper limit
    		 21.8

    Secondary: Clinical Benefit Rate Assessed by the IRC and the Investigator

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    End point title
    		 Clinical Benefit Rate Assessed by the IRC and the Investigator
    End point description
    Clinical benefit rate is defined as the percentage of participants who achieved a confirmed complete response, partial response, or durable stable disease assessed by the IRC and the Investigator per RECIST v1.1. Response evaluations were performed using computed tomography or MRI approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) < 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. Durable SD: Stable disease for ≥ 24 weeks. Response (CR or PR) must have been confirmed 4 weeks or later after the first response.
    End point type
    Secondary
    End point timeframe
    Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
    End point values
    		 Arm A: Tislelizumab Plus Ociperlimab Arm B: Tislelizumab Plus Placebo
    Number of subjects analysed
    62
    63
    Units: percentage of participants
    number (confidence interval 95%)
        Investigator Assessment
    33.9 (22.3 to 47.0)
    30.2 (19.2 to 43.0)
        Independent Review Committee
    32.3 (20.9 to 45.3)
    27.0 (16.6 to 39.7)
    Statistical analysis title
    		 Analysis of CBR Assessed by the Investigator
    Statistical analysis description
    Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score [0 vs 1] and number of organs with metastases [≤ 1 vs ≥ 2]).
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Stratified Risk Difference
    Point estimate
    3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.7
         upper limit
    		 20.4
    Statistical analysis title
    		 Analysis of CBR Assessed by the IRC
    Statistical analysis description
    Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score [0 vs 1] and number of organs with metastases [≤ 1 vs ≥ 2]).
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Stratified Risk Difference
    Point estimate
    5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11
         upper limit
    		 21

    Secondary: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores

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    End point title
    		 Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores
    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) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycle 5 Day 1 and Cycle 7 Day 1 (each cycle was 3 weeks)
    End point values
    		 Arm A: Tislelizumab Plus Ociperlimab Arm B: Tislelizumab Plus Placebo
    Number of subjects analysed
    50 [3]
    48 [4]
    Units: score on a scale
    least squares mean (confidence interval 95%)
        Global Health Status/QOL: Cycle 5
    1.7 (-5.6 to 8.9)
    -0.1 (-7.5 to 7.4)
        Global Health Status/QOL: Cycle 7
    0.3 (-5.6 to 6.1)
    -2.8 (-8.8 to 3.2)
        Physical Functioning: Cycle 5
    -0.5 (-4.3 to 3.3)
    1.2 (-2.8 to 5.2)
        Physical Functioning: Cycle 7
    -4.4 (-11.2 to 2.5)
    -3.9 (-11.0 to 3.3)
    Notes
    [3] - ITT Analysis Set with EORTC QLQ-C30 Baseline values; Cycle 5: n=32; Cycle 7: n=21
    [4] - ITT Analysis Set with EORTC QLQ-C30 Baseline values; Cycle 5: n=30; Cycle 7: n=20
    Statistical analysis title
    		 Analysis of GHS/QoL at Cycle 5
    Statistical analysis description
    The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.4
         upper limit
    		 11.9
    Statistical analysis title
    		 Analysis of GHS/QoL at Cycle 7
    Statistical analysis description
    The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 11.2
    Statistical analysis title
    		 Analysis of Physical Functioning at Cycle 5
    Statistical analysis description
    The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.1
         upper limit
    		 3.7
    Statistical analysis title
    		 Analysis of Physical Functioning at Cycle 7
    Statistical analysis description
    The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.3
         upper limit
    		 9.3

    Secondary: Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain Scales

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    End point title
    		 Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain Scales
    End point description
    The EORTC-QLQ-OES18 is the specific esophageal symptoms module of the QLQ-C30. QLQ-OES18 is comprised of 18 questions grouped into 4 multi-item subscales: Dysphagia (3 items), Eating (4 items), Reflux (2 items), and Pain (3 items) and 6 single item subscales (saliva swallowing, choking, dry mouth, taste, coughing, and talking). Participants indicate the extent to which they have experienced symptoms on a scale from 1 (Not at all) to 4 (Very much). Scores are calculated and transformed to a scale from 0 to 100; higher scores indicate a higher level of symptomatology or problems.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycle 5 Day 1 and Cycle 7 Day 1 (each cycle was 3 weeks)
    End point values
    		 Arm A: Tislelizumab Plus Ociperlimab Arm B: Tislelizumab Plus Placebo
    Number of subjects analysed
    52 [5]
    48 [6]
    Units: score on a scale
    least squares mean (confidence interval 95%)
        Dysphagia: Cycle 5
    -5.9 (-14.2 to 2.4)
    4.1 (-4.7 to 12.8)
        Dysphagia: Cycle 7
    -3.5 (-15.4 to 8.5)
    7.3 (-5.2 to 19.8)
        Eating: Cycle 5
    -1.6 (-6.6 to 3.3)
    -1.3 (-6.6 to 4.1)
        Eating: Cycle 7
    -2.8 (-9.1 to 3.6)
    6.6 (-0.2 to 13.4)
        Reflux: Cycle 5
    1.9 (-4.6 to 8.3)
    -0.4 (-7.1 to 6.4)
        Reflux: Cycle 7
    2.7 (-4.8 to 10.1)
    4.0 (-3.8 to 11.8)
        Pain: Cycle 5
    0.1 (-5.5 to 5.6)
    -0.7 (-6.5 to 5.1)
        Pain: Cycle 7
    -2.1 (-7.1 to 3.0)
    3.3 (-2.0 to 8.5)
    Notes
    [5] - ITT Analysis Set with QLQ-OES18 Baseline values; Cycle 5 n=34 (33 for Reflux & Pain); Cycle 7 n=22
    [6] - ITT Analysis Set with QLQ-OES18 Baseline values; Cycle 5 n=30 (29 for Eating); Cycle 7 n=20
    Statistical analysis title
    		 Analysis of Dysphagia at Cycle 5
    Statistical analysis description
    The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -9.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.5
         upper limit
    		 1.6
    Statistical analysis title
    		 Analysis of Dysphagia at Cycle 7
    Statistical analysis description
    The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -10.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.8
         upper limit
    		 6.3
    Statistical analysis title
    		 Analysis of Eating at Cycle 5
    Statistical analysis description
    The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 6.6
    Statistical analysis title
    		 Analysis of Eating at Cycle 7
    Statistical analysis description
    The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -9.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.5
         upper limit
    		 -0.3
    Statistical analysis title
    		 Analysis of Reflux at Cycle 5
    Statistical analysis description
    The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.7
         upper limit
    		 11.2
    Statistical analysis title
    		 Analysis of Reflux at Cycle 7
    Statistical analysis description
    The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.8
         upper limit
    		 9
    Statistical analysis title
    		 Analysis of Pain at Cycle 5
    Statistical analysis description
    The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 8.5
    Statistical analysis title
    		 Analysis of Pain at Cycle 7
    Statistical analysis description
    The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.
    Comparison groups
    Arm A: Tislelizumab Plus Ociperlimab v Arm B: Tislelizumab Plus Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.3
         upper limit
    		 1.7

    Secondary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    End point description
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not. An SAE is any event that: -Resulted in death. -Was life-threatening. -Required hospitalization or prolongation of existing hospitalization. -Resulted in disability/incapacity. -Was a congenital anomaly/birth defect. -Was considered a significant medical AE by the Investigator. AEs were considered related to study drug if there was evidence to suggest a causal relationship. The investigator assessed the severity of each AE reported based on National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0, where ≥ 3 includes severe or medically significant, life-threatening events or death related to AE. Immune-mediated AEs were diagnosed by the investigator. TEAEs leading to death excludes death due to disease under study.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug until 30 days after last dose; median duration of treatment was 3.45 months in Tislelizumab + Ociperlimab arm and 2.79 months in the Tislelizumab + Placebo arm.
    End point values
    		 Arm A: Tislelizumab Plus Ociperlimab Arm B: Tislelizumab Plus Placebo
    Number of subjects analysed
    62
    63
    Units: participants
        Any TEAEs
    58
    60
        TEAE ≥ Grade 3
    28
    28
        Serious AEs
    27
    28
        Related SAEs
    13
    13
        TEAEs Leading to Treatment Discontinuation
    9
    10
        TEAEs Leading to Death
    4
    4
        Any Immune-Mediated AE
    31
    21
        Immune-Mediated AE ≥ Grade 3
    8
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs are reported from first dose of study drug until 30 days after last dose; median duration of treatment was 3.45 months in Tislelizumab + Ociperlimab arm and 2.79 months in the Tislelizumab + Placebo arm.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Arm B: Tislelizumab Plus Placebo
    Reporting group description
    		 Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

    Reporting group title
    Arm A: Tislelizumab Plus Ociperlimab
    Reporting group description
    		 Participants received 200 mg tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

    Serious adverse events
    		 Arm B: Tislelizumab Plus Placebo Arm A: Tislelizumab Plus Ociperlimab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 63 (44.44%)
    27 / 62 (43.55%)
         number of deaths (all causes)
    36
    39
         number of deaths resulting from adverse events
    10
    8
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour haemorrhage
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         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 / 63 (3.17%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 63 (1.59%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 2
    General physical health deterioration
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         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
    Interstitial lung disease
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated lung disease
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acquired tracheo-oesophageal fistula
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Productive cough
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 63 (1.59%)
    4 / 62 (6.45%)
         occurrences causally related to treatment / all
    0 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Injury, poisoning and procedural complications
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fracture
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated myocarditis
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal fistula
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal obstruction
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal stenosis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Immune-mediated dermatitis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophysitis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Secondary adrenocortical insufficiency
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         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
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 63 (7.94%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    5 / 5
    1 / 2
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Arm B: Tislelizumab Plus Placebo Arm A: Tislelizumab Plus Ociperlimab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 63 (85.71%)
    57 / 62 (91.94%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    1 / 63 (1.59%)
    4 / 62 (6.45%)
         occurrences all number
    1
    4
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 63 (0.00%)
    5 / 62 (8.06%)
         occurrences all number
    0
    5
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    6 / 63 (9.52%)
    5 / 62 (8.06%)
         occurrences all number
    8
    6
    Chest pain
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    Chills
         subjects affected / exposed
    0 / 63 (0.00%)
    3 / 62 (4.84%)
         occurrences all number
    0
    3
    Fatigue
         subjects affected / exposed
    5 / 63 (7.94%)
    8 / 62 (12.90%)
         occurrences all number
    5
    8
    Malaise
         subjects affected / exposed
    3 / 63 (4.76%)
    1 / 62 (1.61%)
         occurrences all number
    3
    1
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 62 (1.61%)
         occurrences all number
    2
    3
    Oedema peripheral
         subjects affected / exposed
    1 / 63 (1.59%)
    2 / 62 (3.23%)
         occurrences all number
    1
    2
    Peripheral swelling
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    Pyrexia
         subjects affected / exposed
    5 / 63 (7.94%)
    4 / 62 (6.45%)
         occurrences all number
    5
    6
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    3 / 63 (4.76%)
    3 / 62 (4.84%)
         occurrences all number
    3
    4
    Oropharyngeal pain
         subjects affected / exposed
    3 / 63 (4.76%)
    0 / 62 (0.00%)
         occurrences all number
    3
    0
    Dyspnoea
         subjects affected / exposed
    3 / 63 (4.76%)
    5 / 62 (8.06%)
         occurrences all number
    3
    5
    Dysphonia
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 62 (1.61%)
         occurrences all number
    2
    1
    Cough
         subjects affected / exposed
    13 / 63 (20.63%)
    7 / 62 (11.29%)
         occurrences all number
    17
    7
    Productive cough
         subjects affected / exposed
    4 / 63 (6.35%)
    4 / 62 (6.45%)
         occurrences all number
    4
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    5 / 63 (7.94%)
    4 / 62 (6.45%)
         occurrences all number
    6
    6
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    9 / 63 (14.29%)
    4 / 62 (6.45%)
         occurrences all number
    9
    7
    Aspartate aminotransferase increased
         subjects affected / exposed
    8 / 63 (12.70%)
    4 / 62 (6.45%)
         occurrences all number
    8
    9
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 62 (1.61%)
         occurrences all number
    2
    1
    Blood bilirubin increased
         subjects affected / exposed
    3 / 63 (4.76%)
    0 / 62 (0.00%)
         occurrences all number
    3
    0
    Blood creatine phosphokinase MB increased
         subjects affected / exposed
    2 / 63 (3.17%)
    2 / 62 (3.23%)
         occurrences all number
    3
    3
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 63 (1.59%)
    5 / 62 (8.06%)
         occurrences all number
    2
    7
    Blood creatinine increased
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 62 (1.61%)
         occurrences all number
    2
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 63 (1.59%)
    3 / 62 (4.84%)
         occurrences all number
    1
    4
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    Blood urea increased
         subjects affected / exposed
    3 / 63 (4.76%)
    1 / 62 (1.61%)
         occurrences all number
    3
    1
    Electrocardiogram high voltage
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    Lymphocyte count decreased
         subjects affected / exposed
    3 / 63 (4.76%)
    6 / 62 (9.68%)
         occurrences all number
    3
    9
    Neutrophil count decreased
         subjects affected / exposed
    4 / 63 (6.35%)
    2 / 62 (3.23%)
         occurrences all number
    10
    5
    Platelet count decreased
         subjects affected / exposed
    3 / 63 (4.76%)
    2 / 62 (3.23%)
         occurrences all number
    3
    2
    SARS-CoV-2 test positive
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    Tri-iodothyronine decreased
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    Weight decreased
         subjects affected / exposed
    6 / 63 (9.52%)
    10 / 62 (16.13%)
         occurrences all number
    6
    11
    White blood cell count decreased
         subjects affected / exposed
    4 / 63 (6.35%)
    4 / 62 (6.45%)
         occurrences all number
    10
    9
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 63 (0.00%)
    4 / 62 (6.45%)
         occurrences all number
    0
    4
    Headache
         subjects affected / exposed
    0 / 63 (0.00%)
    4 / 62 (6.45%)
         occurrences all number
    0
    4
    Hypoaesthesia
         subjects affected / exposed
    1 / 63 (1.59%)
    2 / 62 (3.23%)
         occurrences all number
    1
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    20 / 63 (31.75%)
    17 / 62 (27.42%)
         occurrences all number
    25
    29
    Thrombocytopenia
         subjects affected / exposed
    5 / 63 (7.94%)
    1 / 62 (1.61%)
         occurrences all number
    5
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    3 / 63 (4.76%)
    2 / 62 (3.23%)
         occurrences all number
    5
    2
    Constipation
         subjects affected / exposed
    8 / 63 (12.70%)
    13 / 62 (20.97%)
         occurrences all number
    8
    14
    Diarrhoea
         subjects affected / exposed
    6 / 63 (9.52%)
    9 / 62 (14.52%)
         occurrences all number
    6
    9
    Dry mouth
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    Dysphagia
         subjects affected / exposed
    4 / 63 (6.35%)
    2 / 62 (3.23%)
         occurrences all number
    5
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 63 (3.17%)
    4 / 62 (6.45%)
         occurrences all number
    2
    5
    Haemorrhoids
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    Nausea
         subjects affected / exposed
    5 / 63 (7.94%)
    4 / 62 (6.45%)
         occurrences all number
    5
    4
    Oesophageal obstruction
         subjects affected / exposed
    1 / 63 (1.59%)
    3 / 62 (4.84%)
         occurrences all number
    1
    3
    Stomatitis
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 62 (1.61%)
         occurrences all number
    2
    1
    Vomiting
         subjects affected / exposed
    5 / 63 (7.94%)
    5 / 62 (8.06%)
         occurrences all number
    5
    5
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 63 (1.59%)
    3 / 62 (4.84%)
         occurrences all number
    1
    4
    Rash
         subjects affected / exposed
    3 / 63 (4.76%)
    8 / 62 (12.90%)
         occurrences all number
    3
    9
    Pruritus
         subjects affected / exposed
    2 / 63 (3.17%)
    6 / 62 (9.68%)
         occurrences all number
    2
    6
    Eczema
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    Dry skin
         subjects affected / exposed
    0 / 63 (0.00%)
    3 / 62 (4.84%)
         occurrences all number
    0
    3
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    2 / 63 (3.17%)
    3 / 62 (4.84%)
         occurrences all number
    2
    3
    Hypothyroidism
         subjects affected / exposed
    13 / 63 (20.63%)
    11 / 62 (17.74%)
         occurrences all number
    15
    14
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 63 (0.00%)
    3 / 62 (4.84%)
         occurrences all number
    0
    4
    Back pain
         subjects affected / exposed
    6 / 63 (9.52%)
    3 / 62 (4.84%)
         occurrences all number
    6
    4
    Myalgia
         subjects affected / exposed
    1 / 63 (1.59%)
    2 / 62 (3.23%)
         occurrences all number
    1
    2
    Neck pain
         subjects affected / exposed
    2 / 63 (3.17%)
    1 / 62 (1.61%)
         occurrences all number
    2
    1
    Pain in extremity
         subjects affected / exposed
    2 / 63 (3.17%)
    2 / 62 (3.23%)
         occurrences all number
    2
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 63 (3.17%)
    6 / 62 (9.68%)
         occurrences all number
    3
    7
    Pneumonia
         subjects affected / exposed
    4 / 63 (6.35%)
    3 / 62 (4.84%)
         occurrences all number
    4
    3
    Tuberculosis
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 63 (9.52%)
    2 / 62 (3.23%)
         occurrences all number
    7
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    11 / 63 (17.46%)
    6 / 62 (9.68%)
         occurrences all number
    12
    6
    Hypercalcaemia
         subjects affected / exposed
    0 / 63 (0.00%)
    4 / 62 (6.45%)
         occurrences all number
    0
    4
    Hyperchloraemia
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    Hyperglycaemia
         subjects affected / exposed
    2 / 63 (3.17%)
    3 / 62 (4.84%)
         occurrences all number
    2
    3
    Hyperkalaemia
         subjects affected / exposed
    1 / 63 (1.59%)
    3 / 62 (4.84%)
         occurrences all number
    3
    9
    Hypernatraemia
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    Hyperuricaemia
         subjects affected / exposed
    1 / 63 (1.59%)
    3 / 62 (4.84%)
         occurrences all number
    1
    3
    Hypoalbuminaemia
         subjects affected / exposed
    10 / 63 (15.87%)
    9 / 62 (14.52%)
         occurrences all number
    17
    14
    Hypocalcaemia
         subjects affected / exposed
    1 / 63 (1.59%)
    3 / 62 (4.84%)
         occurrences all number
    1
    3
    Hypochloraemia
         subjects affected / exposed
    4 / 63 (6.35%)
    3 / 62 (4.84%)
         occurrences all number
    5
    3
    Hypokalaemia
         subjects affected / exposed
    6 / 63 (9.52%)
    8 / 62 (12.90%)
         occurrences all number
    6
    8
    Hypomagnesaemia
         subjects affected / exposed
    2 / 63 (3.17%)
    2 / 62 (3.23%)
         occurrences all number
    2
    2
    Hyponatraemia
         subjects affected / exposed
    7 / 63 (11.11%)
    9 / 62 (14.52%)
         occurrences all number
    8
    10
    Hypophosphataemia
         subjects affected / exposed
    0 / 63 (0.00%)
    3 / 62 (4.84%)
         occurrences all number
    0
    4
    Hypoproteinaemia
         subjects affected / exposed
    1 / 63 (1.59%)
    2 / 62 (3.23%)
         occurrences all number
    1
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jun 2022
    Protocol Amendment 1.0 Key Changes: • Revised the expected number of randomized patients from approximately 280 to approximately 120, as a result of the wide use of anti-PD-L1 agents in earlier lines of therapy and consequent enrollment difficulties. The patient enrollment was incomplete by the release of Protocol Amendment 1.0. • Converted OS from a primary to secondary objective because the reduced sample size would not support OS as a primary endpoint. • Updated the study design to unblind the sponsor (the sponsor was unblinded but investigators, site staff, and patients remained blinded) to allow the sponsor to review data across treatment arms.
    27 Feb 2023
    Protocol Amendment 2.0 Key Changes: • Deleted the GLP compliance sentence from the pivotal toxicology studies based on the latest Tislelizumab Investigator’s Brochure. • Added the patient supply treatment program to clarify the opportunity for continued treatment according to the current practice of the sponsor. • Revised the testing method of the null hypothesis of ORR from the Miettinen and Nurminen test to Cochran-Mantel-Haenszel method, as the latter one is a more commonly used testing method for ORR. • Revised the percentage and number of the OS events from 70% (84 deaths) of the total sample size of 120 patients to 60% (72 deaths) in the secondary efficacy analysis as a sponsor’s decision to change data maturity for OS analysis.

    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
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