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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03493451
Recruitment Status : Active, not recruiting
First Posted : April 10, 2018
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

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).


Condition or disease Intervention/treatment Phase
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 Drug: Tislelizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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 : April 13, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : May 2021


Arm Intervention/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 Name: BGB-A317




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Duration of response (DOR) [ Time Frame: Up to 2 years ]
  2. Progression-free survival (PFS) [ Time Frame: Up to 2 years ]
  3. Overall survival (OS) [ Time Frame: Up to 2 years ]
  4. Rate of complete response [ Time Frame: Up to 2 years ]
  5. Time to Response (TTR) [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493451


Locations
Show Show 34 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Jason Paik, MD BeiGene
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03493451    
Other Study ID Numbers: BGB-A317-207
2017-003700-44 ( EudraCT Number )
CTR20171387 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell, Cutaneous
Lymphoma, Extranodal NK-T-Cell
Immunoblastic Lymphadenopathy
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphadenopathy