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).
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
| Drug | Synonyms | Arms |
|---|
| Tislelizumab | BGB-A317 | NK/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
| Name | Type | Description | Interventions |
|---|
| NK/T cell lymphoma and with other mature T-cell neoplasms | Experimental | 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) | |
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) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Duration of response (DOR) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Progression-free survival (PFS) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Overall survival (OS) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Rate of complete response |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Time to Response (TTR) |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| 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
June 9, 2020
