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Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT03924986
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE March 21, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE April 18, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
Progression-free Survival [ Time Frame: up to 2 years. ]
Progression-free survival as assessed by the Independent Review Committee: the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurs first, as assessed by the Independent Review Committee per RECIST v1.1 in an Intent-to-Treat analysis set.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2020)
  • Overall Survival [ Time Frame: up to 2 years. ]
    The time from the date of randomization to the date of death due to any cause in an Intent-to-Treat analysis set.
  • Duration of response [ Time Frame: up to 2 years. ]
    Duration of response as assessed by the Independent Review Committee: the time from the first occurrence of a documented objective response to the time of relapse, or death from any cause, whichever comes first, as assessed by the Independent Review Committee per RECIST v1.1 in all randomized participants with documented objective responses.
  • Overall response rate [ Time Frame: up to 2 years. ]
    Overall response rate as assessed by the Independent Review Committee: the proportion of participants who had complete response or partial response as assessed by the Independent Review Committee per RECIST v1.1 in all randomized participants with measurable disease at baseline.
  • Progression-free survival as assessed by the investigator [ Time Frame: up to 2 years. ]
    The time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurs first, as assessed by the investigator per RECIST v1.1 in an Intent-to-Treat analysis set.
  • Progression-free survival after next line of treatment as assessed by the investigator [ Time Frame: up to 2 years. ]
    The time from randomization to second/subsequent disease progression after initiation of new anticancer therapy, or death from any cause, whichever occurs first.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Overall Survival [ Time Frame: up to 2 years. ]
    The time from the date of randomization to the date of death due to any cause in an Intent-to-Treat analysis set.
  • Duration of response [ Time Frame: up to 2 years. ]
    Duration of response as assessed by the Independent Review Committee: the time from the first occurrence of a documented objective response to the time of relapse, or death from any cause, whichever comes first, as assessed by the Independent Review Committee per RECIST v1.1 in all randomized patients with documented objective responses.
  • Overall response rate [ Time Frame: up to 2 years. ]
    Overall response rate as assessed by the Independent Review Committee: the proportion of patients who had complete response or partial response as assessed by the Independent Review Committee per RECIST v1.1 in all randomized patients with measurable disease at baseline.
  • Progression-free survival as assessed by the investigator [ Time Frame: up to 2 years. ]
    The time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurs first, as assessed by the investigator per RECIST v1.1 in an Intent-to-Treat analysis set.
  • Progression-free survival after next line of treatment as assessed by the investigator [ Time Frame: up to 2 years. ]
    The time from randomization to second/subsequent disease progression after initiation of new anticancer therapy, or death from any cause, whichever occurs first.
  • Health-related quality of life [ Time Frame: up to 2 years ]
    Measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck-43 modules and Core 30 as presented in patient-reported outcomes.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer
Official Title  ICMJE Phase 3, Double-Blind, Randomized Study to Compare the Efficacy and Safety of Tislelizumab Combined With Chemotherapy Versus Chemotherapy as First-Line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Brief Summary This is a Phase 3, Multicenter, Double-Blind, Randomized, Placebo-controlled Study to Compare the Efficacy and Safety of Tislelizumab (BGB-A317) Combined With Gemcitabine Plus Cisplatin Versus Placebo Combined With Gemcitabine Plus Cisplatin as First Line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Recurrent or Metastatic Nasopharyngeal Cancer
Intervention  ICMJE
  • Drug: Tislelizumab
    200 mg administered intravenously (IV)
    Other Name: BGB-A317
  • Drug: Placebo
    Placebo to match Tislelizumab
  • Drug: Gemcitabin
    1 g/m2, administered as an IV infusion within 30 minutes
  • Drug: Cisplatin
    80 mg/m2, administered as an IV infusion over 4 hours
Study Arms  ICMJE
  • Experimental: Tislelizumab combined with Gemcitabine Plus Cisplatin

    Tislelizumab will be administered once every 3 weeks (Q3W)

    Gemcitabine on Day 1, Day 8 of each 3 week cycle, for 4 to 6 cycles

    Cisplatin on Day 1 of each 3 week cycle, for 4 to 6 cycles

    Interventions:
    • Drug: Tislelizumab
    • Drug: Gemcitabin
    • Drug: Cisplatin
  • Placebo Comparator: Placebo combined with Gemcitabine Plus Cisplatin

    Placebo will be administered once every 3 weeks (Q3W)

    Gemcitabine on Day 1, Day 8 of 3 week each cycle, for 4 to 6 cycles

    Cisplatin on Day 1 of 3 week each cycle, for 4 to 6 cycles

    Interventions:
    • Drug: Placebo
    • Drug: Gemcitabin
    • Drug: Cisplatin
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2019)
256
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
  2. Aged between 18 to 75 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)
  3. Histologically or cytologically confirmed, recurrent or metastatic NPC
  4. Participants must be able to provide fresh or archival tumor tissues (FFPE blocks or approximately 10 [≥ 6] freshly cut unstained FFPE slides) with an associated pathological report. The archival tumor tissues must be collected within 2 years before screening. In the absence of sufficient archival tumor tissues, a fresh biopsy of a tumor lesion at baseline is mandatory
  5. ECOG performance status ≤ 1
  6. Must have ≥ 1 measurable lesions as defined per RECIST v1.1
  7. Must be treatment-naive for recurrent or metastatic nasopharyngeal cancer (NPC)

Key Exclusion Criteria:

  1. Participants with locally recurrence suitable for curative surgery or radiotherapy
  2. Received any approved systemic anticancer therapy, including hormonal therapy, within 28 days prior to initiation of study treatment. The following exception is allowed:

    -Palliative radiotherapy for bone metastases or soft tissue lesions should be completed > 7 days prior to baseline imaging.

  3. Has received any immunotherapy (including but not limited to interferons, interleukin 2, tumor necrosis factor interleukin, and thymoxin) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) of randomization
  4. Received prior therapies targeting PD-1 or PD-L1
  5. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  6. Active autoimmune diseases or history of autoimmune diseases that may relapse
  7. Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE China,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03924986
Other Study ID Numbers  ICMJE BGB-A317-309
CTR20182534 ( 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: No
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
Principal Investigator: Li Zhang, MD Sun Yat-sen University
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