Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer
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| ClinicalTrials.gov Identifier: NCT03924986 |
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Recruitment Status :
Active, not recruiting
First Posted : April 23, 2019
Last Update Posted : July 18, 2022
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Sponsor:
BeiGene
Information provided by (Responsible Party):
BeiGene
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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 |
| 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 |
| Actual Primary Completion Date : | March 26, 2021 |
| Estimated Study Completion Date : | June 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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 |
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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 :
- 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 :
- 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.
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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:
- Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
- 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)
- Histologically or cytologically confirmed, recurrent or metastatic NPC
- 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
- ECOG performance status ≤ 1
- Must have ≥ 1 measurable lesions as defined per RECIST v1.1
- Must be treatment-naive for recurrent or metastatic nasopharyngeal cancer (NPC)
Key Exclusion Criteria:
- Participants with locally recurrence suitable for curative surgery or radiotherapy
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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.
- 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
- Received prior therapies targeting PD-1 or PD-L1
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- 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
Locations
Show 42 study locations
Sponsors and Collaborators
BeiGene
Investigators
| Principal Investigator: | Li Zhang, MD | Sun Yat-sen University |
| 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: | July 18, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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 Recurrence Disease Attributes Pathologic Processes 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 |