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

Sponsor
BeiGene (Industry)
Overall Status
Completed
CT.gov ID
NCT03493451
Collaborator
(none)
77
Enrollment
34
Locations
1
Arm
36.9
Actual Duration (Months)
2.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
N/A
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- Neoplasms
Actual Study Start Date :
Apr 13, 2018
Actual Primary Completion Date :
May 11, 2021
Actual Study Completion Date :
May 11, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: NK/T cell lymphoma and with other mature T-cell neoplasms

In 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)

Drug: Tislelizumab
200 mg IV on Day 1 of each 21-day cycle.
Other Names:
  • BGB-A317
  • Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) for Cohort 1 and 2 [Up to 2 years]

      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

    2. Objective Response Rate (ORR) for Cohort 3 [Up to 2 years]

      defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) measured using the ISCL/EORTC guidelines

    Secondary Outcome Measures

    1. Duration of response (DOR) for all cohorts [Up to 2 years]

      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.

    2. Progression-free survival (PFS) for all cohorts [Up to 2 years]

      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.

    3. Overall survival (OS) ) for cohort 1 and cohort 2 [Up to 2 years]

      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.

    4. Rate of complete response or complete metabolic response for all cohorts. [Up to 2 years]

      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.

    5. Time to Response (TTR) as assessed by the investigator [Up to 2 years]

      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.

    6. 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 [Up to 2 years]

      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).

    7. Patient-reported outcomes based on EuroQoL-Five Dimensions, Five Levels (EQ-5D-5L) for all cohorts [Up to 2 years]

      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.

    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 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

    SiteCityStateCountryPostal Code
    1North Shore University HospitalLake SuccessNew YorkUnited States11042
    2Thomas Jefferson UniversityPhiladelphiaPennsylvaniaUnited States19107
    3Froedtert & Medical College of Wisconsin - Froedtert Hospital - Clinical Cancer CenterMilwaukeeWisconsinUnited States53226
    4UBC - British Columbia Cancer Agency - The Vancouver CentreVancouverBritish ColumbiaCanadaV5Z 4E6
    5Peking University Third HospitalBeijingBeijingChina100000
    6Beijing HospitalBeijingBeijingChina100730
    7Peking Union Medical College HospitalBeijingBeijingChina100730
    8Fujian Medical University Union HospitalFuzhouFujianChina350001
    9Sun Yat-Sen University Cancer CenterGuangzhouGuangdongChina510060
    10He Nan Cancer HospitalZhengzhouHe NanChina450008
    11Affiliated Tumor Hospital of Harbin Medical UniversityHarbinHeilongjiangChina150000
    12The First Affiliated Hospital of Soochow UniversitySuzhouJiangsuChina215006
    13The affiliated hospital of Xuzhou medical universityXuzhouJiangsuChina221002
    14Fudan university Shanghai Cancer CenterShanghaiShanghaiChina200032
    15Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghaiShanghaiChina200092
    16West China Hospital of Sichuan UniversityChengduSichuanChina610041
    17Tianjin Cancer HospitalTianjinTianjinChina300060
    18Zhejiang Cancer HospitalHangzhouZhejiangChina310022
    19Institut d'hématologie de Basse NormandieCaenFrance14000
    20Centre hospitalier Universitaire de LimogesLimogesFrance87000
    21Centre hospitalier Lyon SudPierre-BéniteFrance69310
    22Universitätsmedizin GöttingenGöttingenNiedersachsenGermany37075
    23Universitätsklinikum HalleHalleSachsen-AnhaltGermany06120
    24Universitätsklinikum Leipzig AöRLeipzigSachsenGermany04103
    25Queen Mary HospitalHong KongHong Kong00000
    26Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-MalpighiBolognaEmiliaItaly40138
    27Ospedale Maggiore, AOU ParmaParmaEmiliaItaly43100
    28Ospedale Policlinico San Martino - IRCCS per l'OncologiaGenovaLiguriaItaly16132
    29ASST Papa Giovanni XXIIBergamoLombardiaItaly24127
    30Ospedale San RaffaeleMilanoLombardiaItaly20123
    31A.O.U. Pisana, Stabilimento di Santa ChiaraPisaToscanaItaly56126
    32Azienda Ospedaliera Santa Maria di TerniTerniUmbriaItaly05100
    33National Cheng Kung University HospitalTainanTaiwan70403
    34National Taiwan University HospitalTaipeiTaiwan10002

    Sponsors and Collaborators

    • BeiGene

    Investigators

    • Study Director: Jason Paik, MD, BeiGene

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jul 8, 2021
    Last Verified:
    Jul 1, 2021
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 8, 2021