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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

Tracking Information
First Submitted Date  ICMJE April 4, 2018
First Posted Date  ICMJE April 10, 2018
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE April 13, 2018
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
Objective response rate (ORR) [ Time Frame: Up to 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
  • Duration of response (DOR) [ Time Frame: Up to 2 years ]
  • Progression-free survival (PFS) [ Time Frame: Up to 2 years ]
  • Overall survival (OS) [ Time Frame: Up to 2 years ]
  • Rate of complete response [ Time Frame: Up to 2 years ]
  • Time to Response (TTR) [ Time Frame: Up to 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK- Neoplasms
Official Title  ICMJE A Phase 2, Open-Label Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK- Neoplasms
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Drug: Tislelizumab
200 mg IV on Day 1 of each 21-day cycle.
Other Name: BGB-A317
Study Arms  ICMJE 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)
Intervention: Drug: Tislelizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2018)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   China,   France,   Germany,   Hong Kong,   Italy,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03493451
Other Study ID Numbers  ICMJE BGB-A317-207
2017-003700-44 ( EudraCT Number )
CTR20171387 ( Registry Identifier: Center for drug evaluation, CFDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jason Paik, MD BeiGene
PRS Account BeiGene
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP