Trial · NCT03924986
Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer (NPC)
NCT03924986, Phase 3, Completed, BeiGene; results first posted 2025-01-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer (NPC). Trials, record NCT03924986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03924986
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer (NPC)
- NCT number
- NCT03924986
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 263 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Recurrent or Metastatic Nasopharyngeal Cancer
- Interventions
- Tislelizumab, Placebo, Gemcitabine, Cisplatin
- First posted
- 2019-04-23
- Last updated
- 2025-01-31
- Results first posted
- 2025-01-31
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival as Assessed by the Independent Review Committee (IRC) | Through the study interim data analysis cutoff date of March 26th, 2021 (maximum time on study follow-up was 23 months) | Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Kaplan-Meier methodology was used to estimate the median PFS. |
| Secondary | Overall Response Rate (ORR) as Assessed by the IRC | Through the study interim data analysis cutoff date of March 26th, 2021 (maximum time on study follow-up was 23 months) | Defined as the percentage of participants who had complete response or partial response as assessed by the IRC per RECIST v1.1 in all randomized participants with measurable disease at Baseline. |
| Secondary | Duration of Response (DOR) as Assessed by the IRC | Through the study interim data analysis cutoff date of March 26th, 2021 (maximum time on study follow-up was 23 months) | Defined as the time from the first occurrence of a documented objective response to the time of relapse, or death from any cause, whichever occurred first, as assessed by the IRC per RECIST v1.1 in all randomized participants with documented objective responses. |
| Secondary | Overall Survival (OS) as Assessed by the IRC | Through study completion data cut-off date of December 8th, 2023 or last available date showing participants alive (maximum time on study follow-up was 53 months) | Defined as the time from the date of randomization to the date of death due to any cause. |
| Secondary | PFS as Assessed by the Investigator | Through the interim analysis data cut-off date of March 26th, 2021 (up to approximately 23 months) | Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the investigator per RECIST v1.1. |
| Secondary | Progression-free Survival After Next Line of Treatment (PFS2) as Assessed by the Investigator | Through the study completion data cut-off date of December 8th, 2023 (maximum time on study follow-up was 53 months) | Defined as the time from randomization to second/subsequent disease progression after initiation of new anticancer therapy, or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. |
| Secondary | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status | Baseline to Cycle 6 (Each cycle is 21 days) | Change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. |
| Secondary | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck-351 (EORTC QLQ-H&N35) Index Score | Baseline to Cycle 6 (Each cycle is 21 days) | The QLQ-H\&N35 consists of thirty-five questions that are associated with eighteen symptom scales (pain, swallowing, senses, speech, social eating, social contact, sexuality, problem with teeth, problem opening mouth, dry mouth, problem with sense smell, cough, felt ill, pain med, nutritional supplements, feeding tube, weight loss and weight gain).. Raw scores are transformed into a 0 to 100 scale via linear transformation. The index score is calculated as an average of the 18 symptom scales. A negative change from baseline score indicates improvement in symptoms. |
| Secondary | Number of Participants With Adverse Events | From first dose to 30 days after last dose or new anticancer therapy, or until Dec 8, 2023 data cut-off; max treatment duration: 231 weeks (Arm A), 202 weeks (Arm B). | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory tests, vital signs, electrocardiograms (ECGs), and physical examinations (PEs ), graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. For Arm B, only adverse events reported prior to participants crossing over to receive tislelizumab monotherapy are included. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival as Assessed by the Independent Review Committee (IRC) | Through the study interim data analysis cutoff date of March 26th, 2021 (maximum time on study follow-up was 23 months) | ITT analysis set | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) as Assessed by the IRC | Through the study interim data analysis cutoff date of March 26th, 2021 (maximum time on study follow-up was 23 months) | ITT analysis set | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Assessed by the IRC | Through the study interim data analysis cutoff date of March 26th, 2021 (maximum time on study follow-up was 23 months) | ITT analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in the analysis. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) as Assessed by the IRC | Through study completion data cut-off date of December 8th, 2023 or last available date showing participants alive (maximum time on study follow-up was 53 months) | ITT analysis set | Months | MEDIAN |
| SECONDARY | PFS as Assessed by the Investigator | Through the interim analysis data cut-off date of March 26th, 2021 (up to approximately 23 months) | ITT analysis set | months | MEDIAN |
| SECONDARY | Progression-free Survival After Next Line of Treatment (PFS2) as Assessed by the Investigator | Through the study completion data cut-off date of December 8th, 2023 (maximum time on study follow-up was 53 months) | ITT analysis set | months | MEDIAN |
| SECONDARY | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status | Baseline to Cycle 6 (Each cycle is 21 days) | The HRQoL analysis set includes all randomized participants who received any dose of study drug and completed at least one HRQoL assessment. Only participants with data at both baseline and the each postbaseline visit are included in the summary statistics for change from baseline. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck-351 (EORTC QLQ-H&N35) Index Score | Baseline to Cycle 6 (Each cycle is 21 days) | The HRQoL analysis set includes all randomized participants who received any dose of study drug and completed at least one HRQoL assessment. Only participants with data at both baseline and the each postbaseline visit are included in the summary statistics for change from baseline. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Adverse Events | From first dose to 30 days after last dose or new anticancer therapy, or until Dec 8, 2023 data cut-off; max treatment duration: 231 weeks (Arm A), 202 weeks (Arm B). | The Safety analysis set includes all randomized participants who received any dose of any component of study drug. Two participants randomized to Arm B who received 100 mg tislelizumab in error were analyzed as part of Arm A for the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival as Assessed by the Independent Review Committee (IRC) | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 9.2 | 95% Confidence Interval 7.6 to 10.1 | Months | |
| Progression-free Survival as Assessed by the Independent Review Committee (IRC) | Arm B: Placebo + Gemcitabine + Cisplatin | 7.4 | 95% Confidence Interval 5.6 to 7.5 | Months | |
| Overall Response Rate (ORR) as Assessed by the IRC | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 69.5 | 95% Confidence Interval 60.8 to 77.2 | percentage of participants | |
| Overall Response Rate (ORR) as Assessed by the IRC | Arm B: Placebo + Gemcitabine + Cisplatin | 55.3 | 95% Confidence Interval 46.4 to 64.0 | percentage of participants | |
| Duration of Response (DOR) as Assessed by the IRC | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 8.5 | 95% Confidence Interval 6.5 to NA | months | |
| Duration of Response (DOR) as Assessed by the IRC | Arm B: Placebo + Gemcitabine + Cisplatin | 6.1 | 95% Confidence Interval 4.7 to 6.2 | months | |
| Overall Survival (OS) as Assessed by the IRC | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 45.3 | 95% Confidence Interval 33.4 to NA | Months | |
| Overall Survival (OS) as Assessed by the IRC | Arm B: Placebo + Gemcitabine + Cisplatin | 31.8 | 95% Confidence Interval 25.0 to NA | Months | |
| PFS as Assessed by the Investigator | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 9.8 | 95% Confidence Interval 7.8 to 11.9 | months | |
| PFS as Assessed by the Investigator | Arm B: Placebo + Gemcitabine + Cisplatin | 7.6 | 95% Confidence Interval 6.6 to 7.8 | months |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 131 | |
| Overall Study | STARTED | Arm B: Placebo + Gemcitabine + Cisplatin | 132 | |
| Overall Study | Treated | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 131 | |
| Overall Study | Treated | Arm B: Placebo + Gemcitabine + Cisplatin | 132 | |
| Overall Study | Crossed Over to Tislelizumab | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 0 | |
| Overall Study | Crossed Over to Tislelizumab | Arm B: Placebo + Gemcitabine + Cisplatin | 70 | |
| Overall Study | COMPLETED | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 0 | |
| Overall Study | COMPLETED | Arm B: Placebo + Gemcitabine + Cisplatin | 0 | |
| Overall Study | NOT COMPLETED | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 131 | |
| Overall Study | NOT COMPLETED | Arm B: Placebo + Gemcitabine + Cisplatin | 132 |
Source ClinicalTrials.gov
Adverse events624
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 114 | 133 | 273 |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Placebo + Gemcitabine + Cisplatin | 117 | 130 | 235 |
| other | Anaemia | Blood and lymphatic system disorders | Post Crossover Tislelizumab | 19 | 70 | 40 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 46 | 133 | 281 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm B: Placebo + Gemcitabine + Cisplatin | 44 | 130 | 204 |
| other | Leukopenia | Blood and lymphatic system disorders | Post Crossover Tislelizumab | 2 | 70 | 6 |
| other | Myelosuppression | Blood and lymphatic system disorders | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 4 | 133 | 5 |
| other | Myelosuppression | Blood and lymphatic system disorders | Arm B: Placebo + Gemcitabine + Cisplatin | 1 | 130 | 1 |
| other | Myelosuppression | Blood and lymphatic system disorders | Post Crossover Tislelizumab | 0 | 70 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 46 | 133 | 218 |
1 to 10 of 624Source ClinicalTrials.gov
See all 624 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 57 | 133 |
| Total, all-cause mortality | Arm B: Placebo + Gemcitabine + Cisplatin | 31 | 130 |
| Total, all-cause mortality | Post Crossover Tislelizumab | 35 | 70 |
| Total, other adverse events | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 133 | 133 |
| Total, other adverse events | Arm B: Placebo + Gemcitabine + Cisplatin | 129 | 130 |
| Total, other adverse events | Post Crossover Tislelizumab | 60 | 70 |
| Total, serious adverse events | Arm A: Tislelizumab + Gemcitabine + Cisplatin | 47 | 133 |
| Total, serious adverse events | Arm B: Placebo + Gemcitabine + Cisplatin | 46 | 130 |
| Total, serious adverse events | Post Crossover Tislelizumab | 15 | 70 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03924986
GET https://conductscience.org/api/trials/v1/NCT03924986/events?page=2