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Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms

Sponsor
BeiGene (Industry)
Overall Status
Completed
CT.gov ID
NCT03493451
Collaborator
(none)
77
Enrollment
30
Locations
3
Arms
36.3
Actual Duration (Months)
2.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This was a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There were three cohorts:

  • Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or non-nasal type)

  • Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL)

  • Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary syndrome (SS)

Study procedures included a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all adverse events (AEs) and serious adverse events (SAEs)); and Survival follow-up phase (duration varying by participant).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Open-Label Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK-cell Neoplasms
Actual Study Start Date :
Apr 13, 2018
Actual Primary Completion Date :
Apr 21, 2021
Actual Study Completion Date :
Apr 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1: ENKTL

Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

Drug: Tislelizumab
Administered intravenously
Other Names:
  • BGB-A317

    		•
    Experimental: Cohort 2: PTCL-NOS, AITL, and ALCL

    Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

    Drug: Tislelizumab
    Administered intravenously
    Other Names:
  • BGB-A317

    		•
    Experimental: Cohort 3: MF and SS

    Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

    Drug: Tislelizumab
    Administered intravenously
    Other Names:
  • BGB-A317

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate (ORR) [Up to approximately 3 years and 1 week]

      ORR is defined as the percentage of participants achieving a best overall response of complete response or partial response as determined by the investigator using Lugano criteria with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) modification for cohorts 1 and 2 and International Society for Cutaneous Lymphomas/European Organization of Research and Treatment of Cancer (ISCL/EORTC) guidelines for cohort 3.

    Secondary Outcome Measures

    1. Duration of Response (DOR) [Up to approximately 3 years and 1 week]

      DOR defined as the time from the first determination of an objective response until progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.

    2. Progression-free Survival (PFS) [Up to approximately 3 years and 1 week]

      PFS is defined as the time from first study drug administration to the date of disease progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.

    3. Overall Survival (OS) [Up to approximately 3 years and 1 week]

      OS defined as the time from first study drug administration to the date of death due to any reason for cohorts 1 and 2.

    4. Complete Response Rate (CRR) [Up to approximately 3 years and 1 week]

      CRR is defined as the percentage of participants who achieve complete response or complete metabolic response as best overall response as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.

    5. Time to Response (TTR) [Up to approximately 3 years and 1 week]

      Time to response defined as the time from first study drug administration to the time the response criteria (complete response or partial response) are first met as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.

    6. Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score [Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)]

      Mean change from baseline at safety follow-up visit in EQ-5D-5L visual analogue score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' An increasing score indicates improvements from baseline.

    7. Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score [Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)]

      Mean change from baseline at safety follow-up visit in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes global health status and quality of life questions related to their overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a higher score indicating improved health status.

    8. Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score [Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)]

      Mean change from baseline at safety follow-up visit in EORTC QLQ-C30 Fatigue score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes questions related to fatigue symptoms in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a higher score indicating improved health status.

    9. Number of Participants With Adverse Events [Up to approximately 3 years and 1 week]

      Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically relevant changes in laboratory tests, physical examination, electrocardiogram, and vital signs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Key Inclusion Criteria

    • Confirmed diagnosis of relapsed or refractory extranodal NK/T-cell lymphoma (nasal or non-nasal type, peripheral T-cell lymphoma - not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, mycosis fungoides, or Sezary syndrome)

    • Age 18 years or older

    • Relapsed or refractory to at least 1 prior systemic therapy

    • Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) for participants in Cohort 1 and 2

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

    • Life expectancy ≥ 6 months

    • Adequate respiratory function

    • Adequate bone marrow function

    • Adequate renal and hepatic function

    Key Exclusion Criteria

    • Known central nervous system (CNS) involvement by lymphoma

    • Previously received immune checkpoint therapy

    • Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 or lower prostate cancer

    • Active autoimmune disease or history of autoimmune diseases that may relapse with some exceptions

    • Severe or debilitating pulmonary disease

    • Clinically significant cardiovascular disease

    • Active fungal, bacterial, and/or viral infection requiring systemic therapy

    • Known infection with HIV or active viral hepatitis B or C infection

    • Major surgery within 4 weeks of the first dose of study drug

    • Pregnant or lactating women

    • Vaccination with a live vaccine within 35 days prior to the first dose of study drug

    • Hypersensitivity to tislelizumab

    • Concurrent participation in another therapeutic clinical trial

    NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UBC - British Columbia Cancer Agency - The Vancouver Centre Vancouver British Columbia Canada V5Z 4E6
    2 Peking University Third Hospital Beijing Beijing China 100000
    3 Beijing Hospital Beijing Beijing China 100730
    4 Peking Union Medical College Hospital Beijing Beijing China 100730
    5 Fujian Medical University Union Hospital Fuzhou Fujian China 350001
    6 Sun Yat-Sen University Cancer Center Guangzhou Guangdong China 510060
    7 He Nan Cancer Hospital Zhengzhou He Nan China 450008
    8 Affiliated Tumor Hospital of Harbin Medical University Harbin Heilongjiang China 150000
    9 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215006
    10 The affiliated hospital of Xuzhou medical university Xuzhou Jiangsu China 221002
    11 Fudan university Shanghai Cancer Center Shanghai Shanghai China 200032
    12 Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200092
    13 West China Hospital of Sichuan University Chengdu Sichuan China 610041
    14 Tianjin Cancer Hospital Tianjin Tianjin China 300060
    15 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022
    16 Institut d'hématologie de Basse Normandie Caen France 14000
    17 Centre hospitalier Universitaire de Limoges Limoges France 87000
    18 Centre hospitalier Lyon Sud Pierre-Bénite France 69310
    19 Universitätsmedizin Göttingen Göttingen Niedersachsen Germany 37075
    20 Universitätsklinikum Halle Halle Sachsen-Anhalt Germany 06120
    21 Universitätsklinikum Leipzig AöR Leipzig Sachsen Germany 04103
    22 Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi Bologna Emilia Italy 40138
    23 Ospedale Maggiore, AOU Parma Parma Emilia Italy 43100
    24 Ospedale Policlinico San Martino - IRCCS per l'Oncologia Genova Liguria Italy 16132
    25 ASST Papa Giovanni XXII Bergamo Lombardia Italy 24127
    26 Ospedale San Raffaele Milano Lombardia Italy 20123
    27 A.O.U. Pisana, Stabilimento di Santa Chiara Pisa Toscana Italy 56126
    28 Azienda Ospedaliera Santa Maria di Terni Terni Umbria Italy 05100
    29 National Cheng Kung University Hospital Tainan Taiwan 70403
    30 National Taiwan University Hospital Taipei Taiwan 10002

    Sponsors and Collaborators

    • BeiGene

    Investigators

    • Study Director: Study Director, BeiGene

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT03493451
    Other Study ID Numbers:
    • BGB-A317-207
    • 2017-003700-44
    • CTR20171387
    First Posted:
    Apr 10, 2018
    Last Update Posted:
    May 4, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by BeiGene
    T/NK-cell
    NK/T-cell
    extranodal
    nasal
    NK-cell
    ENKTL
    peripheral T-cell
    anaplastic large cell
    ALCL
    angioimmunoblastic
    PTCL-NOS
    Relapsed
    Refractory
    Additional relevant MeSH terms:
    Lymphoma
    Neoplasms
    Lymphoma, Non-Hodgkin
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Peripheral
    Lymphoma, Large-Cell, Anaplastic
    Lymphoma, T-Cell, Cutaneous
    Lymphoma, Extranodal NK-T-Cell
    Immunoblastic Lymphadenopathy

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled from study centers in Canada, China, France, Italy, and Taiwan, China.
    Pre-assignment Detail
    Arm/Group Title Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS
    Arm/Group Description Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    Period Title: Overall Study
    STARTED 22 44 11
    COMPLETED 0 0 0
    NOT COMPLETED 22 44 11

    Baseline Characteristics

    Arm/Group Title Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS Total
    Arm/Group Description Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Total of all reporting groups
    Overall Participants 22 44 11 77
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    51.5
    (16.24)
    55.8
    (15.03)
    59.4
    (12.45)
    55.1
    (15.09)
    Sex: Female, Male (Count of Participants)
    Female
    8
    36.4%
    15
    34.1%
    3
    27.3%
    26
    33.8%
    Male
    14
    63.6%
    29
    65.9%
    8
    72.7%
    51
    66.2%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    19
    86.4%
    23
    52.3%
    2
    18.2%
    44
    57.1%
    White
    2
    9.1%
    18
    40.9%
    8
    72.7%
    28
    36.4%
    Not Reported
    1
    4.5%
    3
    6.8%
    1
    9.1%
    5
    6.5%
    Region of Enrollment (Number) [Number]
    Canada
    0
    0%
    0
    0%
    2
    18.2%
    2
    2.6%
    China
    19
    86.4%
    22
    50%
    0
    0%
    41
    53.2%
    Taiwan
    0
    0%
    1
    2.3%
    0
    0%
    1
    1.3%
    Italy
    2
    9.1%
    18
    40.9%
    8
    72.7%
    28
    36.4%
    France
    1
    4.5%
    3
    6.8%
    1
    9.1%
    5
    6.5%

    Outcome Measures

    1. Primary Outcome
    Title Overall Response Rate (ORR)
    Description ORR is defined as the percentage of participants achieving a best overall response of complete response or partial response as determined by the investigator using Lugano criteria with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) modification for cohorts 1 and 2 and International Society for Cutaneous Lymphomas/European Organization of Research and Treatment of Cancer (ISCL/EORTC) guidelines for cohort 3.
    Time Frame Up to approximately 3 years and 1 week

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set includes all participants who received at least one dose of study drug
    Arm/Group Title Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS
    Arm/Group Description Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    Measure Participants 22 44 11
    Number (95% Confidence Interval) [Percentage of participants]
    31.8
    144.5%
    20.5
    46.6%
    45.5
    413.6%
    2. Secondary Outcome
    Title Duration of Response (DOR)
    Description DOR defined as the time from the first determination of an objective response until progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.
    Time Frame Up to approximately 3 years and 1 week

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set includes all participants who received at least one dose of study drug; Duration of response was summarized for responders (participants who achieved a partial or complete response).
    Arm/Group Title Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS
    Arm/Group Description Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    Measure Participants 7 9 5
    Median (95% Confidence Interval) [Months]
    NA
    8.2
    11.3
    3. Secondary Outcome
    Title Progression-free Survival (PFS)
    Description PFS is defined as the time from first study drug administration to the date of disease progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.
    Time Frame Up to approximately 3 years and 1 week

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set includes all participants who received at least one dose of study drug
    Arm/Group Title Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS
    Arm/Group Description Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    Measure Participants 22 44 11
    Median (95% Confidence Interval) [Months]
    2.7
    2.7
    16.8
    4. Secondary Outcome
    Title Overall Survival (OS)
    Description OS defined as the time from first study drug administration to the date of death due to any reason for cohorts 1 and 2.
    Time Frame Up to approximately 3 years and 1 week

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set includes all participants who received at least one dose of study drug
    Arm/Group Title Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL
    Arm/Group Description Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    Measure Participants 22 44
    Median (95% Confidence Interval) [Months]
    8.8
    13.3
    5. Secondary Outcome
    Title Complete Response Rate (CRR)
    Description CRR is defined as the percentage of participants who achieve complete response or complete metabolic response as best overall response as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.
    Time Frame Up to approximately 3 years and 1 week

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set includes all participants who received at least one dose of study drug
    Arm/Group Title Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS
    Arm/Group Description Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    Measure Participants 22 44 11
    Number (95% Confidence Interval) [Percentage of participants]
    18.2
    82.7%
    9.1
    20.7%
    9.1
    82.7%
    6. Secondary Outcome
    Title Time to Response (TTR)
    Description Time to response defined as the time from first study drug administration to the time the response criteria (complete response or partial response) are first met as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.
    Time Frame Up to approximately 3 years and 1 week

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set includes all participants who received at least one dose of study drug; Time to response was summarized for responders (participants who achieved a partial or complete response).
    Arm/Group Title Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS
    Arm/Group Description Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    Measure Participants 7 9 5
    Median (Full Range) [Months]
    5.75
    2.86
    6.83
    7. Secondary Outcome
    Title Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score
    Description Mean change from baseline at safety follow-up visit in EQ-5D-5L visual analogue score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' An increasing score indicates improvements from baseline.
    Time Frame Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire.
    Arm/Group Title Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS
    Arm/Group Description Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    Measure Participants 22 44 11
    Cycle 5, Day 1
    4.42
    (10.273)
    1.11
    (13.884)
    0.25
    (22.276)
    Cycle 9, Day 1
    1.17
    (4.916)
    5.56
    (21.279)
    -0.83
    (17.713)
    Cycle 13, Day 1
    -3.29
    (16.650)
    15.00
    (19.685)
    1.33
    (21.398)
    Cycle 17, Day 1
    0.17
    (9.326)
    10.00
    (17.889)
    3.67
    (23.551)
    Cycle 21, Day 1
    4.25
    (10.905)
    8.33
    (22.546)
    5.50
    (18.285)
    Cycle 25, Day 1
    4.00
    (14.422)
    -2.50
    (10.607)
    5.00
    (7.071)
    Cycle 29, Day 1
    -2.67
    (4.619)
    -5.00
    (7.071)
    Cycle 33, Day 1
    -3.00
    (NA)
    0.00
    (NA)
    Safety Follow-up
    -1.50
    (8.546)
    -9.52
    (21.047)
    12.50
    (3.536)
    8. Secondary Outcome
    Title Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score
    Description Mean change from baseline at safety follow-up visit in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes global health status and quality of life questions related to their overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a higher score indicating improved health status.
    Time Frame Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire.
    Arm/Group Title Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS
    Arm/Group Description Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    Measure Participants 22 44 11
    Cycle 5, Day 1
    7.64
    (24.220)
    6.67
    (19.041)
    10.42
    (24.296)
    Cycle 9, Day 1
    8.33
    (10.541)
    12.04
    (28.294)
    1.39
    (21.995)
    Cycle 13, Day 1
    4.76
    (11.644)
    -1.67
    (19.003)
    2.78
    (15.516)
    Cycle 17, Day 1
    2.78
    (12.546)
    6.94
    (30.008)
    4.17
    (21.570)
    Cycle 21, Day 1
    12.50
    (14.434)
    0.00
    (33.333)
    0.00
    (20.412)
    Cycle 25, Day 1
    14.58
    (25.797)
    -8.33
    (11.785)
    -4.17
    (5.893)
    Cycle 29, Day 1
    16.67
    (16.667)
    -8.33
    (11.785)
    Cycle 33, Day 1
    0.00
    (NA)
    0.00
    (NA)
    Safety Follow-up
    7.74
    (27.045)
    -14.93
    (26.917)
    20.83
    (17.678)
    9. Secondary Outcome
    Title Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score
    Description Mean change from baseline at safety follow-up visit in EORTC QLQ-C30 Fatigue score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes questions related to fatigue symptoms in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a higher score indicating improved health status.
    Time Frame Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire.
    Arm/Group Title Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS
    Arm/Group Description Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    Measure Participants 22 44 11
    Cycle 5, Day 1
    -2.78
    (14.312)
    7.02
    (14.912)
    1.39
    (41.335)
    Cycle 9, Day 1
    0.00
    (12.172)
    -1.39
    (11.011)
    -22.22
    (41.574)
    Cycle 13, Day 1
    -1.59
    (11.878)
    -6.67
    (12.669)
    -5.56
    (18.257)
    Cycle 17, Day 1
    9.26
    (16.355)
    1.85
    (10.924)
    -12.96
    (16.355)
    Cycle 21, Day 1
    0.00
    (12.830)
    11.11
    (11.111)
    -16.67
    (14.344)
    Cycle 25, Day 1
    0.00
    (15.713)
    27.78
    (7.857)
    -5.56
    (7.857)
    Cycle 29, Day 1
    3.70
    (27.962)
    22.22
    (15.713)
    Cycle 33, Day 1
    11.11
    (NA)
    33.33
    (NA)
    Safety Follow-up
    -1.59
    (19.903)
    7.87
    (30.820)
    -44.44
    (31.427)
    10. Secondary Outcome
    Title Number of Participants With Adverse Events
    Description Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically relevant changes in laboratory tests, physical examination, electrocardiogram, and vital signs
    Time Frame Up to approximately 3 years and 1 week

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set includes all participants who received at least one dose of study drug
    Arm/Group Title Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS
    Arm/Group Description Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    Measure Participants 22 44 11
    At least one TEAE
    22
    100%
    41
    93.2%
    10
    90.9%
    SAEs
    9
    40.9%
    21
    47.7%
    5
    45.5%

    Adverse Events

    Time Frame Up to approximately 3 years and 1 week
    Adverse Event Reporting Description Adverse events were graded by the investigators using Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
    Arm/Group Title Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS
    Arm/Group Description Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with other R/R mature T-cell neoplasms [limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) Participants with R/R cutaneous T-cell lymphoma [limited to mycosis fungoides (MF) and Sèzary syndrome (SS)] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    All Cause Mortality
    Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 11/22 (50%) 26/44 (59.1%) 3/11 (27.3%)
    Serious Adverse Events
    Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 9/22 (40.9%) 21/44 (47.7%) 5/11 (45.5%)
    Blood and lymphatic system disorders
    Anaemia 0/22 (0%) 0 2/44 (4.5%) 4 0/11 (0%) 0
    Neutropenia 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Pancytopenia 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Cardiac disorders
    Cardiac failure 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Endocrine disorders
    Hypothyroidism 1/22 (4.5%) 2 0/44 (0%) 0 0/11 (0%) 0
    Eye disorders
    Vision blurred 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Gastrointestinal disorders
    Diarrhoea 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Dyspepsia 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Dysphagia 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Intussusception 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Lower gastrointestinal haemorrhage 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Nausea 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Vomiting 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    General disorders
    Death 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    General physical health deterioration 0/22 (0%) 0 2/44 (4.5%) 2 0/11 (0%) 0
    Multiple organ dysfunction syndrome 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Pain 0/22 (0%) 0 1/44 (2.3%) 3 0/11 (0%) 0
    Pyrexia 0/22 (0%) 0 4/44 (9.1%) 8 0/11 (0%) 0
    Immune system disorders
    Haemophagocytic lymphohistiocytosis 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Infections and infestations
    Bacteraemia 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Cellulitis staphylococcal 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Oral infection 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Pneumocystis jirovecii pneumonia 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Pneumonia 2/22 (9.1%) 5 4/44 (9.1%) 4 0/11 (0%) 0
    Pneumonia cryptococcal 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Pseudomonal sepsis 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Respiratory tract infection 0/22 (0%) 0 1/44 (2.3%) 2 0/11 (0%) 0
    Sepsis 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Staphylococcal sepsis 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 2
    Tonsillitis 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Upper respiratory tract infection 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Varicella zoster virus infection 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Investigations
    Epstein-Barr virus test positive 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Hypercalcaemia 0/22 (0%) 0 2/44 (4.5%) 2 0/11 (0%) 0
    Hyponatraemia 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Back pain 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Tumour flare 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Tumour rupture 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Tumour ulceration 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Nervous system disorders
    Dizziness 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Syncope 0/22 (0%) 0 1/44 (2.3%) 1 1/11 (9.1%) 1
    Psychiatric disorders
    Depression 1/22 (4.5%) 2 0/44 (0%) 0 0/11 (0%) 0
    Renal and urinary disorders
    Renal failure 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Renal impairment 0/22 (0%) 0 1/44 (2.3%) 1 1/11 (9.1%) 2
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Immune-mediated lung disease 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Interstitial lung disease 0/22 (0%) 0 1/44 (2.3%) 4 0/11 (0%) 0
    Pneumonitis 0/22 (0%) 0 1/44 (2.3%) 1 0/11 (0%) 0
    Respiratory failure 1/22 (4.5%) 1 0/44 (0%) 0 1/11 (9.1%) 2
    Skin and subcutaneous tissue disorders
    Skin ulcer 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Vascular disorders
    Arterial haemorrhage 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 2
    Other (Not Including Serious) Adverse Events
    Cohort 1: ENKTL Cohort 2: PTCL-NOS, AITL, and ALCL Cohort 3: MF and SS
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 21/22 (95.5%) 39/44 (88.6%) 10/11 (90.9%)
    Blood and lymphatic system disorders
    Anaemia 6/22 (27.3%) 14 7/44 (15.9%) 8 0/11 (0%) 0
    Lymph node pain 0/22 (0%) 0 2/44 (4.5%) 4 0/11 (0%) 0
    Lymphadenopathy 0/22 (0%) 0 2/44 (4.5%) 4 0/11 (0%) 0
    Neutropenia 0/22 (0%) 0 5/44 (11.4%) 13 0/11 (0%) 0
    Thrombocytopenia 0/22 (0%) 0 7/44 (15.9%) 11 0/11 (0%) 0
    Cardiac disorders
    Angina pectoris 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Atrial fibrillation 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Conduction disorder 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Extrasystoles 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Palpitations 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Sinus tachycardia 1/22 (4.5%) 1 1/44 (2.3%) 1 0/11 (0%) 0
    Ear and labyrinth disorders
    Deafness 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Deafness unilateral 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 2
    Tinnitus 1/22 (4.5%) 1 2/44 (4.5%) 2 0/11 (0%) 0
    Vertigo 0/22 (0%) 0 2/44 (4.5%) 2 0/11 (0%) 0
    Endocrine disorders
    Hyperthyroidism 0/22 (0%) 0 2/44 (4.5%) 3 0/11 (0%) 0
    Hypothyroidism 1/22 (4.5%) 1 5/44 (11.4%) 5 3/11 (27.3%) 4
    Eye disorders
    Blepharitis 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Cataract 1/22 (4.5%) 1 0/44 (0%) 0 1/11 (9.1%) 2
    Eversion of lacrimal punctum 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Eyelid oedema 0/22 (0%) 0 1/44 (2.3%) 1 1/11 (9.1%) 1
    Lacrimation increased 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Periorbital oedema 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Retinal disorder 1/22 (4.5%) 2 0/44 (0%) 0 0/11 (0%) 0
    Retinopathy 3/22 (13.6%) 3 0/44 (0%) 0 0/11 (0%) 0
    Gastrointestinal disorders
    Abdominal distension 2/22 (9.1%) 2 0/44 (0%) 0 0/11 (0%) 0
    Abdominal pain 1/22 (4.5%) 2 2/44 (4.5%) 2 2/11 (18.2%) 2
    Abdominal pain upper 1/22 (4.5%) 1 1/44 (2.3%) 2 0/11 (0%) 0
    Constipation 0/22 (0%) 0 4/44 (9.1%) 4 2/11 (18.2%) 2
    Diarrhoea 3/22 (13.6%) 3 4/44 (9.1%) 4 4/11 (36.4%) 5
    Dyspepsia 1/22 (4.5%) 1 0/44 (0%) 0 1/11 (9.1%) 1
    Dysphagia 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Haemorrhoids 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Lower gastrointestinal haemorrhage 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Mouth ulceration 0/22 (0%) 0 3/44 (6.8%) 4 0/11 (0%) 0
    Nausea 3/22 (13.6%) 3 1/44 (2.3%) 1 2/11 (18.2%) 2
    Oral cavity fistula 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Stomatitis 2/22 (9.1%) 3 1/44 (2.3%) 1 2/11 (18.2%) 2
    Toothache 0/22 (0%) 0 2/44 (4.5%) 2 0/11 (0%) 0
    Vomiting 2/22 (9.1%) 2 0/44 (0%) 0 3/11 (27.3%) 3
    General disorders
    Asthenia 1/22 (4.5%) 2 8/44 (18.2%) 9 2/11 (18.2%) 2
    Chest discomfort 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Face oedema 1/22 (4.5%) 1 0/44 (0%) 0 1/11 (9.1%) 1
    Fatigue 0/22 (0%) 0 2/44 (4.5%) 3 1/11 (9.1%) 2
    Influenza like illness 0/22 (0%) 0 1/44 (2.3%) 2 3/11 (27.3%) 3
    Malaise 3/22 (13.6%) 3 1/44 (2.3%) 1 0/11 (0%) 0
    Non-cardiac chest pain 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 2
    Oedema peripheral 2/22 (9.1%) 2 3/44 (6.8%) 3 4/11 (36.4%) 6
    Pyrexia 6/22 (27.3%) 13 13/44 (29.5%) 25 4/11 (36.4%) 7
    Swelling face 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Infections and infestations
    Bronchitis 2/22 (9.1%) 2 0/44 (0%) 0 1/11 (9.1%) 1
    COVID-19 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Conjunctivitis 1/22 (4.5%) 1 1/44 (2.3%) 1 0/11 (0%) 0
    Gingivitis 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Herpes simplex 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Impetigo 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Influenza 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Nasopharyngitis 1/22 (4.5%) 1 2/44 (4.5%) 3 1/11 (9.1%) 1
    Pharyngitis 1/22 (4.5%) 1 1/44 (2.3%) 1 0/11 (0%) 0
    Pneumonia 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Pseudomonal skin infection 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Rhinitis 2/22 (9.1%) 2 1/44 (2.3%) 1 0/11 (0%) 0
    Skin bacterial infection 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Skin infection 1/22 (4.5%) 1 1/44 (2.3%) 1 1/11 (9.1%) 1
    Upper respiratory tract infection 2/22 (9.1%) 2 5/44 (11.4%) 8 0/11 (0%) 0
    Urinary tract infection 0/22 (0%) 0 1/44 (2.3%) 1 1/11 (9.1%) 1
    Wound infection 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Injury, poisoning and procedural complications
    Contusion 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Procedural pain 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Investigations
    Activated partial thromboplastin time prolonged 1/22 (4.5%) 2 0/44 (0%) 0 0/11 (0%) 0
    Alanine aminotransferase increased 1/22 (4.5%) 1 3/44 (6.8%) 5 0/11 (0%) 0
    Alpha hydroxybutyrate dehydrogenase increased 0/22 (0%) 0 2/44 (4.5%) 3 0/11 (0%) 0
    Aspartate aminotransferase increased 3/22 (13.6%) 4 3/44 (6.8%) 3 0/11 (0%) 0
    Blood albumin decreased 0/22 (0%) 0 2/44 (4.5%) 3 0/11 (0%) 0
    Blood bilirubin increased 2/22 (9.1%) 5 1/44 (2.3%) 2 0/11 (0%) 0
    Blood creatine phosphokinase MB increased 1/22 (4.5%) 1 1/44 (2.3%) 1 0/11 (0%) 0
    Blood creatine phosphokinase increased 2/22 (9.1%) 5 1/44 (2.3%) 1 1/11 (9.1%) 4
    Blood creatinine increased 0/22 (0%) 0 3/44 (6.8%) 6 1/11 (9.1%) 1
    Blood lactate dehydrogenase increased 1/22 (4.5%) 1 4/44 (9.1%) 7 0/11 (0%) 0
    Blood thyroid stimulating hormone decreased 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Blood thyroid stimulating hormone increased 1/22 (4.5%) 2 1/44 (2.3%) 1 0/11 (0%) 0
    C-reactive protein increased 0/22 (0%) 0 2/44 (4.5%) 2 0/11 (0%) 0
    Gamma-glutamyltransferase increased 1/22 (4.5%) 1 1/44 (2.3%) 1 0/11 (0%) 0
    Haemoglobin decreased 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Lymphocyte count decreased 3/22 (13.6%) 9 0/44 (0%) 0 0/11 (0%) 0
    Neutrophil count decreased 4/22 (18.2%) 16 2/44 (4.5%) 2 0/11 (0%) 0
    Platelet count decreased 2/22 (9.1%) 10 4/44 (9.1%) 5 0/11 (0%) 0
    Tri-iodothyronine free decreased 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Weight decreased 4/22 (18.2%) 8 4/44 (9.1%) 5 0/11 (0%) 0
    Weight increased 3/22 (13.6%) 11 2/44 (4.5%) 2 0/11 (0%) 0
    White blood cell count decreased 4/22 (18.2%) 21 3/44 (6.8%) 6 0/11 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 1/22 (4.5%) 1 1/44 (2.3%) 1 1/11 (9.1%) 1
    Diabetes mellitus 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Gout 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Hyperglycaemia 4/22 (18.2%) 4 4/44 (9.1%) 5 1/11 (9.1%) 1
    Hypertriglyceridaemia 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Hypoalbuminaemia 5/22 (22.7%) 8 1/44 (2.3%) 1 1/11 (9.1%) 1
    Hypocalcaemia 2/22 (9.1%) 3 1/44 (2.3%) 1 0/11 (0%) 0
    Hypokalaemia 4/22 (18.2%) 4 2/44 (4.5%) 3 0/11 (0%) 0
    Hyponatraemia 3/22 (13.6%) 7 0/44 (0%) 0 0/11 (0%) 0
    Impaired fasting glucose 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Malnutrition 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 3/22 (13.6%) 5 7/44 (15.9%) 18 3/11 (27.3%) 5
    Back pain 1/22 (4.5%) 1 0/44 (0%) 0 1/11 (9.1%) 1
    Intervertebral disc protrusion 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Muscle spasms 1/22 (4.5%) 1 0/44 (0%) 0 1/11 (9.1%) 1
    Musculoskeletal chest pain 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Osteoporosis 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Pain in extremity 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Pain in jaw 1/22 (4.5%) 2 0/44 (0%) 0 0/11 (0%) 0
    Tendonitis 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of skin 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 4
    Tumour flare 0/22 (0%) 0 1/44 (2.3%) 1 1/11 (9.1%) 1
    Nervous system disorders
    Dizziness 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Headache 0/22 (0%) 0 2/44 (4.5%) 2 0/11 (0%) 0
    Peripheral sensorimotor neuropathy 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Peripheral sensory neuropathy 0/22 (0%) 0 3/44 (6.8%) 3 0/11 (0%) 0
    Syncope 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 2
    Psychiatric disorders
    Delirium 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Insomnia 0/22 (0%) 0 4/44 (9.1%) 4 1/11 (9.1%) 1
    Renal and urinary disorders
    Renal impairment 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Respiratory, thoracic and mediastinal disorders
    Asthma 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Cough 4/22 (18.2%) 4 7/44 (15.9%) 10 0/11 (0%) 0
    Dyspnoea 0/22 (0%) 0 2/44 (4.5%) 3 1/11 (9.1%) 1
    Epistaxis 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Hiccups 0/22 (0%) 0 2/44 (4.5%) 3 0/11 (0%) 0
    Nasal congestion 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Nasal obstruction 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Oropharyngeal pain 1/22 (4.5%) 1 1/44 (2.3%) 1 0/11 (0%) 0
    Pharyngeal ulceration 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Pulmonary embolism 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Respiratory acidosis 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Skin and subcutaneous tissue disorders
    Actinic keratosis 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Blood blister 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Circumoral oedema 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Dermatitis 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Dermatitis psoriasiform 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 2
    Dry skin 1/22 (4.5%) 1 0/44 (0%) 0 0/11 (0%) 0
    Erythema 0/22 (0%) 0 5/44 (11.4%) 10 1/11 (9.1%) 1
    Pruritus 2/22 (9.1%) 3 6/44 (13.6%) 9 3/11 (27.3%) 4
    Rash 1/22 (4.5%) 1 2/44 (4.5%) 2 3/11 (27.3%) 4
    Rash maculo-papular 3/22 (13.6%) 3 1/44 (2.3%) 1 0/11 (0%) 0
    Rash pruritic 0/22 (0%) 0 2/44 (4.5%) 8 0/11 (0%) 0
    Skin mass 0/22 (0%) 0 2/44 (4.5%) 2 0/11 (0%) 0
    Skin ulcer 1/22 (4.5%) 1 0/44 (0%) 0 1/11 (9.1%) 3
    Urticaria 0/22 (0%) 0 1/44 (2.3%) 2 1/11 (9.1%) 1
    Vascular disorders
    Deep vein thrombosis 0/22 (0%) 0 0/44 (0%) 0 1/11 (9.1%) 1
    Hypertension 0/22 (0%) 0 2/44 (4.5%) 2 2/11 (18.2%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.

    Results Point of Contact

    Name/Title Study Director
    Organization BeiGene
    Phone +1-877-828-5568
    Email clinicaltrials@beigene.com
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT03493451
    Other Study ID Numbers:
    • BGB-A317-207
    • 2017-003700-44
    • CTR20171387
    First Posted:
    Apr 10, 2018
    Last Update Posted:
    May 4, 2022
    Last Verified:
    Apr 1, 2022