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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 : July 19, 2019
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 combined with Gemcitabine Plus Cisplatin Drug: Placebo combined with Gemcitabine Plus 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


Arm Intervention/treatment
Experimental: Tislelizumab combined with Gemcitabine Plus Cisplatin

Tislelizumab will be administered at a dose of 200 mg intravenously (IV) once every 3 weeks (Q3W)

Gemcitabine 1 g/m2, Day 1, Day 8 of each cycle, administered as an IV infusion within 30 minutes, for 4 to 6 cycles

Cisplatin 80 mg/m2, Day 1 of each cycle, administered as an IV infusion over 4 hours for 4 to 6 cycles

Drug: Tislelizumab combined with Gemcitabine Plus Cisplatin
Study subjects will receive Tislelizumab, Cisplatin and Gemcitabine on day1 of every 3 weeks, and study subjects will receive Gemcitabine on day8 of every 3 weeks.

Placebo Comparator: Placebo combined with Gemcitabine Plus Cisplatin

Placebo will be administered at a dose of 200 mg intravenously (IV) once every 3 weeks (Q3W)

Gemcitabine 1 g/m2, Day 1, Day 8 of each cycle, administered as an IV infusion within 30 minutes, for 4 to 6 cycles

Cisplatin 80 mg/m2, Day 1 of each cycle, administered as an IV infusion over 4 hours for 4 to 6 cycles

Drug: Placebo combined with Gemcitabine Plus Cisplatin
Study subjects will receive Placebo, Cisplatin and Gemcitabine on day1 of every 3 weeks, and study subjects will receive Gemcitabine on day8 of every 3 weeks.




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 patients 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 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.

  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

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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

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. Patients 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. Patients must have ≥ 1 measurable lesions as defined per RECIST v1.1
  7. Must be treatment-naive for recurrent or metastatic NPC

Exclusion Criteria:

  1. Patients 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)

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: Feng Guo 18510168801 clinicaltrials@beigene.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Yan Sun         
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Li Zhang Sun Yat-sen University

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03924986     History of Changes
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: July 19, 2019
Last Verified: May 2019

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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
Cisplatin
Gemcitabine
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