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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Recurrent or Metastatic Nasopharyngeal Cancer Drug: Tislelizumab Drug: Placebo Drug: Gemcitabin Drug: Cisplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 18, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Drug: Tislelizumab
200 mg administered intravenously (IV)
Other Name: BGB-A317

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

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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


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): NCT03924986


Contacts
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Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com

Locations
Show Show 42 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Li Zhang, MD Sun Yat-sen University
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03924986    
Other Study ID Numbers: BGB-A317-309
CTR20182534 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: June 11, 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: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nasopharyngeal Neoplasms
Nasopharyngeal Carcinoma
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs