Clinical Trials /

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

NCT03493451

Description:

This is 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 will be two cohorts of participants: - Cohort 1: Participants with relapsed or refractory extranodal NK/T cell lymphoma (nasal or non-nasal type) - Cohort 2: other mature T-cell neoplasms (limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified, angioimmunoblastic T-cell lymphoma, or anaplastic large-cell lymphoma) - Cohort 3: cutaneous T-cell lymphoma (limited to mycosis fungoides and Sèzary syndrome) Up to 70 participants will be enrolled into cohort 1, up to 50 participants into cohort 2, and up to 10 participants into cohort 3 for a total sample size of up to 130 participants. The primary efficacy endpoint is overall response rate (ORR) determined by investigator assessment. Disease response for the primary endpoint for cohorts 1 and 2 will be assessed per the Lugano criteria with LYRIC modification for immunomodulatory therapy Disease response for the primary endpoint for cohort 3 will be assessed per the International Society for Cutaneous Lymphoma (ISCL)/European Organization for Research and Treatment of Cancer (EORTC) guidelines for immunomodulatory therapy BGB-A317 will be administered intravenously as a 200 mg infusion every 3 weeks (Each cycle consists of 21 days). Study procedures will occur over 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)); Survival follow-up phase (duration varying by participant).

Related Conditions:
  • Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Completed

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03493451

Trial Eligibility

Document

Title

  • Brief Title: Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK- Neoplasms
  • Official Title: A Phase 2, Open-Label Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK- Neoplasms

Clinical Trial IDs

  • ORG STUDY ID: BGB-A317-207
  • SECONDARY ID: 2017-003700-44
  • SECONDARY ID: CTR20171387
  • NCT ID: NCT03493451

Conditions

  • Peripheral T Cell Lymphoma
  • PTCL
  • Extranodal NK/T-cell Lymphoma
  • Extranodal NK/T-cell Lymphoma, Nasal Type
  • Extranodal NK T Cell Lymphoma
  • Extranodal NK T Cell Lymphoma, Nasal
  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Angioimmunoblastic T-Cell Lymphoma Recurrent
  • Angioimmunoblastic T-Cell Lymphoma Refractory
  • Peripheral T-cell Lymphoma NOS
  • Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Peripheral T-Cell Lymphoma Refractory
  • Anaplastic Large Cell Lymphoma
  • Anaplastic Large Cell Lymphoma, ALK-Positive
  • Anaplastic Large Cell Lymphoma, ALK-negative
  • ALK-negative Anaplastic Large Cell Lymphoma
  • ALK-Positive Anaplastic Large Cell Lymphoma
  • Cutaneous T-cell Lymphoma

Interventions

DrugSynonymsArms
TislelizumabBGB-A317NK/T cell lymphoma and with other mature T-cell neoplasms

Purpose

This is 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 will be two cohorts of participants: - Cohort 1: Participants with relapsed or refractory extranodal NK/T cell lymphoma (nasal or non-nasal type) - Cohort 2: other mature T-cell neoplasms (limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified, angioimmunoblastic T-cell lymphoma, or anaplastic large-cell lymphoma) - Cohort 3: cutaneous T-cell lymphoma (limited to mycosis fungoides and Sèzary syndrome) Up to 70 participants will be enrolled into cohort 1, up to 50 participants into cohort 2, and up to 10 participants into cohort 3 for a total sample size of up to 130 participants. The primary efficacy endpoint is overall response rate (ORR) determined by investigator assessment. Disease response for the primary endpoint for cohorts 1 and 2 will be assessed per the Lugano criteria with LYRIC modification for immunomodulatory therapy Disease response for the primary endpoint for cohort 3 will be assessed per the International Society for Cutaneous Lymphoma (ISCL)/European Organization for Research and Treatment of Cancer (EORTC) guidelines for immunomodulatory therapy BGB-A317 will be administered intravenously as a 200 mg infusion every 3 weeks (Each cycle consists of 21 days). Study procedures will occur over 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)); Survival follow-up phase (duration varying by participant).

Trial Arms

NameTypeDescriptionInterventions
NK/T cell lymphoma and with other mature T-cell neoplasmsExperimentalIn this cohort, participants will be treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle.BGB A317 will be administered until disease progression, intolerable toxicity, or treatment discontinuation for any other reason. Cohort 1: Participants with relapsed or refractory extranodal NK/T cell lymphoma (nasal or non-nasal type) Cohort 2: other mature T-cell neoplasms (limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified, angioimmunoblastic T-cell lymphoma, or anaplastic large-cell lymphoma) Cohort 3: cutaneous T-cell lymphoma (limited to mycosis fungoides and Sèzary syndrome)
  • Tislelizumab

Eligibility Criteria

        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 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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR) for Cohort 1 and 2
Time Frame:Up to 2 years
Safety Issue:
Description:defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per the Lugano criteria with LYRIC modification for immunomodulatory drugs

Secondary Outcome Measures

Measure:Duration of response (DOR) for all cohorts
Time Frame:Up to 2 years
Safety Issue:
Description:DOR is the time from the first determination of an objective response until progression or death, whichever occurs first, for all cohorts. Determined per the Lugano criteria with LYRIC modification for immunomodulatory drugs for cohort 1 and 2, and using the ISCL/EORTC guidelines for cohort 3 as assessed by the investigator.
Measure:Progression-free survival (PFS) for all cohorts
Time Frame:Up to 2 years
Safety Issue:
Description:PFS is defined as the time from first study drug administration to the date of disease progression or death, whichever occurs first, for all cohorts. Determined per the Lugano criteria with LYRIC modification for immunomodulatory drugs for cohort 1 and 2, and using the ISCL/EORTC guidelines for cohort 3 as assessed by the investigator.
Measure:Overall survival (OS) ) for cohort 1 and cohort 2
Time Frame:Up to 2 years
Safety Issue:
Description:OS is defined as the time from first study drug administration to the date of death due to any reason, for cohorts 1 and 2. Determined per the Lugano criteria with LYRIC modification for immunomodulatory drugs for cohort 1 and 2 as assessed by the investigator.
Measure:Rate of complete response or complete metabolic response for all cohorts.
Time Frame:Up to 2 years
Safety Issue:
Description:Defined as the proportion of patients who achieve complete response or complete metabolic response as best overall response, for all cohorts. Determined per the Lugano criteria with LYRIC modification for immunomodulatory drugs for cohort 1 and 2, and using the ISCL/EORTC guidelines for cohort 3 as assessed by the investigator.
Measure:Time to Response (TTR) as assessed by the investigator
Time Frame:Up to 2 years
Safety Issue:
Description:TRR is defined as the time from first study drug administration to the time the response criteria (complete response or partial response) are first met, for all cohorts.
Measure:Patient-reported outcomes based on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) for all cohorts
Time Frame:Up to 2 years
Safety Issue:
Description:The EORTC QLQ-C30 is completed by the participant. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).
Measure:Patient-reported outcomes based on EuroQoL-Five Dimensions, Five Levels (EQ-5D-5L) for all cohorts
Time Frame:Up to 2 years
Safety Issue:
Description:The EQ-5D- is a generic, self-reported measure of utility that consists of a five-item descriptive system and a visual analogue scale (EQ VAS). The descriptive system has two versions, namely the 3L and 5L, both involving five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). In the EQ-5D-5L that will be used, participants may choose from the following five response levels: no problems=1; slight problems=2; moderate problems=3; severe problems=4; and unable to/extreme problems=5. Higher values indicate worst health.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:BeiGene

Trial Keywords

  • T/NK-cell
  • NK/T-cell
  • extranodal
  • nasal
  • NK-cell
  • ENKTL
  • peripheral T-cell
  • anaplastic large cell
  • ALCL
  • angioimmunoblastic
  • PTCL-NOS
  • Relapsed
  • Refractory

Last Updated

July 8, 2021