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This was a dose verification, pharmacokinetic (PK) assessment of products derived from two manufacturing processes and scales (500L-FMP and 2000L-FMP; FMP: Final Manufacturing Process) and indication expansion clinical study of monoclonal antibody conducted in Chinese subjects with advanced solid tumors, with a purpose of exploring the safety, tolerability, pharmacokinetics and preliminary efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab | Experimental | Tislelizumab 200 mg intravenously (IV) once every 3 weeks (21 days per cycle) until no evidence of continued clinical benefits, unacceptable toxicity, or withdrawal of informed consent at the discretion of the investigator. There were 3 parts in this study: dose verification, pharmacokinetic (PK) sub-study, and indication expansion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Administered intravenously |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Verification and PK Sub-study: Number Participants With Adverse Events | Number of participants with adverse events (AEs) and serious adverse events (SAEs), as defined per NCI-CTCAE Version 4.03, including physical examination, electrocardiograms and laboratory assessments | Up to approximately 23 months |
| Dose Verification: Recommended Dose of Tislelizumab | Recommended dose of tislelizumab for indication cohorts based on safety and tolerability | Up to approximately 23 months |
| PK Sub-study: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Tislelizumab From Two Manufacturing Processes and Scales | Pharmacokinetics from products derived from two manufacturing scales at 500 liter and 2000 liter final manufacturing process (FMP) were evaluated | Predose, end of infusion, 3 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22, and Day 29 predose |
| PK Sub-study: Area Under the Concentration-time Curve From Time 0 to 28 Days Postdose (AUC0-28d) of Tislelizumab From Two Manufacturing Processes and Scales | Pharmacokinetics from products derived from two manufacturing scales at 500 liter and 2000 liter final manufacturing process (FMP) were evaluated | Predose, end of infusion, 3 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22, and Day 29 predose |
| PK Sub-study: Maximum Observed Concentration (Cmax) of Tislelizumab From Two Manufacturing Processes and Scales | Pharmacokinetics from products derived from two manufacturing scales at 500 liter and 2000 liter FMP were evaluated | Predose, end of infusion, 3 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22, and Day 29 predose |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Verification: Area Under the Concentration-time Curve From Time 0 to 21 Days Postdose (AUC0-tau) of Tislelizumab | Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 and Cycle 5 (21 days per cycle) | |
| Dose Verification: Maximum Observed Concentration (Cmax) of Tislelizumab |
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Key Inclusion Criteria:
Participants must have histologically or cytologically confirmed advanced or metastatic tumors (unresectable), have had progression or intolerability since last standard anti-tumor treatment, or have no standard treatment or have refused standard therapy.
Participants must be able to provide archival tumor tissues (paraffin blocks or at least 10 unstained tumor specimen slides).
Participants must have at least one measurable lesion as defined per RECIST criterion version 1.1.
Participant must have adequate organ function.
Females are eligible to participate in the study if they are:
a) Non-childbearing potential (that is, physiologically incapable of becoming pregnant) who:
Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study.
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China | ||
| Beijing Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32561638 | Background | Shen L, Guo J, Zhang Q, Pan H, Yuan Y, Bai Y, Liu T, Zhou Q, Zhao J, Shu Y, Huang X, Wang S, Wang J, Zhou A, Ye D, Sun T, Gao Y, Yang S, Wang Z, Li J, Wu YL. Tislelizumab in Chinese patients with advanced solid tumors: an open-label, non-comparative, phase 1/2 study. J Immunother Cancer. 2020 Jun;8(1):e000437. doi: 10.1136/jitc-2019-000437. | |
| Background | Zhou Q et al. Efficacy and safety data from a Phase 1/2 trial of tislelizumab in Chinese patients with non-small cell lung cancer. North America Conference on Lung Cancer, October 2020. | ||
| 36879284 |
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A total of 300 participants were treated with at least 1 dose of tislelizumab. This was a single arm study with 3 parts: dose verification, pharmacokinetic (PK) sub-study, and indication expansion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tislelizumab | Tislelizumab 200 mg was administered intravenously (IV) once every 3 weeks (21 days per cycle) until no evidence of continued clinical benefits, unacceptable toxicity, or withdrawal of informed consent at the discretion of the investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dose Verification |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 30, 2019 | Apr 20, 2022 |
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| Indication Expansion: Objective Response Rate | Objective response rate (ORR) is defined as the percentage of participants who achieved objective tumor response (complete response or partial response) according to RECIST Version 1.1. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and other tumor types. | Up to approximately 3 years and 5 months |
| Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 and Cycle 5 (21 days per cycle) |
| Dose Verification: Predose Plasma Concentration of Tislelizumab During Multiple Dosing (Ctrough) | Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 and Cycle 5 (21 days per cycle) |
| Dose Verification: Apparent Terminal Half-life of Tislelizumab (t1/2) | Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 and Cycle 5 (21 days per cycle) |
| Dose Verification: Clearance (Cl) | Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 (21 days per cycle) |
| Indication Expansion: Progression-free Survival (PFS) | Progression-free survival is defined as the time from the date of first study dose to disease progression or death, whichever comes first, as determined by Investigator per RECIST version 1.1. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and other tumor types. | Up to approximately 3 years and 5 months |
| Indication Expansion: Duration of Response | Duration of response for responders with complete or partial response is defined as the time interval between the date of the earliest qualifying response and the date of progressive disease or death for any cause, whichever occurs earlier as determined by Investigator per RECIST version 1.1. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and other tumor types. | Up to approximately 3 years and 5 months |
| Indication Expansion: Clinical Benefit Rate | Clinical benefit rate is defined as the percentage of participants in specific tumor types reaching confirmed CR, PR and durable stable disease (SD; at ≥ 24 weeks) in accordance with RECIST version 1.1. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and other tumor types. | Up to approximately 3 years and 5 months |
| Indication Expansion: Overall Survival | Overall survival is defined as the time from the date of the first study dose to death. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and other tumor types. | Up to approximately 3 years and 5 months |
| Indication Expansion: Disease Control Rate | Disease control rate is defined as the percentage of participants reaching CR, PR, and SD according to RECIST version 1.1. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and other tumor types. | Up to approximately 3 years and 5 months |
| Number of Participants With Positive Anti-drug Antibody (ADA) Status to Tislelizumab | Up to approximately 23 months |
| Beijing |
| Beijing Municipality |
| 100142 |
| China |
| Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North) | Guangzhou | Guangdong | 510000 | China |
| Guangdong Provincial Peoples Hospital | Guangzhou | Guangdong | 510080 | China |
| The Fifth Affiliated Hospital Sun Yat Sen University | Zhuhai | Guangdong | 519000 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| The First Affiliated Hospital of Nanchang University Branch Donghu | Nanchang | Jiangxi | 330006 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Zhejiang University College of Medicine Second Affiliated Hospital | Hangzhou | Zhejiang | 310009 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| Derived |
| Ye D, Desai J, Shi J, Liu SM, Shen W, Liu T, Shi Y, Wang D, Liang L, Yang S, Ma X, Jin W, Zhang P, Huang R, Shen Z, Zhang Y, Wu YL. Co-enrichment of CD8-positive T cells and macrophages is associated with clinical benefit of tislelizumab in solid tumors. Biomark Res. 2023 Mar 7;11(1):25. doi: 10.1186/s40364-023-00465-w. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Pharmacokinetic Sub-study |
|
|
| Indication Expansion |
|
|
The Safety Analysis Set (SAS) included all participants who received ≥ 1 dose of tislelizumab; Safety analysis data are summarized for the overall population given that the same dose was applied, regardless of part assignment, as pre-specified in the clinical study report.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tislelizumab | Tislelizumab 200 mg was administered intravenously (IV) once every 3 weeks (21 days per cycle) until no evidence of continued clinical benefits, unacceptable toxicity, or withdrawal of informed consent at the discretion of the investigator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dose Verification and PK Sub-study: Number Participants With Adverse Events | Number of participants with adverse events (AEs) and serious adverse events (SAEs), as defined per NCI-CTCAE Version 4.03, including physical examination, electrocardiograms and laboratory assessments | The Safety Analysis Set (SAS) included all participants who received ≥ 1 dose of tislelizumab | Posted | Count of Participants | Participants | Up to approximately 23 months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Dose Verification: Recommended Dose of Tislelizumab | Recommended dose of tislelizumab for indication cohorts based on safety and tolerability | The Safety Analysis Set (SAS) included all participants who received ≥ 1 dose of tislelizumab | Posted | Number | milligrams | Up to approximately 23 months |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | PK Sub-study: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Tislelizumab From Two Manufacturing Processes and Scales | Pharmacokinetics from products derived from two manufacturing scales at 500 liter and 2000 liter final manufacturing process (FMP) were evaluated | The PK Analysis Set included participants in the SAS for whom at least 1 valid PK parameter could be derived for tislelizumab | Posted | Geometric Mean | 95% Confidence Interval | µg/mL*day | Predose, end of infusion, 3 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22, and Day 29 predose |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | PK Sub-study: Area Under the Concentration-time Curve From Time 0 to 28 Days Postdose (AUC0-28d) of Tislelizumab From Two Manufacturing Processes and Scales | Pharmacokinetics from products derived from two manufacturing scales at 500 liter and 2000 liter final manufacturing process (FMP) were evaluated | The PK Analysis Set included participants in the SAS for whom at least 1 valid PK parameter could be derived for tislelizumab | Posted | Geometric Mean | 95% Confidence Interval | µg/mL*day | Predose, end of infusion, 3 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22, and Day 29 predose |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | PK Sub-study: Maximum Observed Concentration (Cmax) of Tislelizumab From Two Manufacturing Processes and Scales | Pharmacokinetics from products derived from two manufacturing scales at 500 liter and 2000 liter FMP were evaluated | PK Analysis Set included participants in the SAS for whom at least 1 valid PK parameter could be derived for tislelizumab | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Predose, end of infusion, 3 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22, and Day 29 predose |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Indication Expansion: Objective Response Rate | Objective response rate (ORR) is defined as the percentage of participants who achieved objective tumor response (complete response or partial response) according to RECIST Version 1.1. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and other tumor types. | The Safety Analysis Set (SAS) included all participants who received ≥ 1 dose of tislelizumab; one participant is included in both MSI-H/dMMR and GC indications. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 3 years and 5 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Dose Verification: Area Under the Concentration-time Curve From Time 0 to 21 Days Postdose (AUC0-tau) of Tislelizumab | PK Analysis Set included participants in the SAS for whom at least 1 valid PK parameter could be derived for tislelizumab | Posted | Mean | Standard Deviation | µg/mL*day | Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 and Cycle 5 (21 days per cycle) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Dose Verification: Maximum Observed Concentration (Cmax) of Tislelizumab | PK Analysis Set included participants in the SAS for whom at least 1 valid PK parameter could be derived for tislelizumab | Posted | Mean | Standard Deviation | µg/mL | Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 and Cycle 5 (21 days per cycle) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Dose Verification: Predose Plasma Concentration of Tislelizumab During Multiple Dosing (Ctrough) | PK Analysis Set included participants in the SAS for whom at least 1 valid PK parameter could be derived for tislelizumab | Posted | Mean | Standard Deviation | µg/mL | Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 and Cycle 5 (21 days per cycle) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Dose Verification: Apparent Terminal Half-life of Tislelizumab (t1/2) | PK Analysis Set included participants in the SAS for whom at least 1 valid PK parameter could be derived for tislelizumab | Posted | Mean | Standard Deviation | Days | Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 and Cycle 5 (21 days per cycle) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Dose Verification: Clearance (Cl) | PK Analysis Set included participants in the SAS for whom at least 1 valid PK parameter could be derived for tislelizumab | Posted | Mean | Standard Deviation | Liters/day | Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 (21 days per cycle) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Indication Expansion: Progression-free Survival (PFS) | Progression-free survival is defined as the time from the date of first study dose to disease progression or death, whichever comes first, as determined by Investigator per RECIST version 1.1. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and other tumor types. | The Safety Analysis Set (SAS) included all participants who received ≥ 1 dose of tislelizumab; one participant is included in both MSI-H/dMMR and GC indications. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 years and 5 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Indication Expansion: Duration of Response | Duration of response for responders with complete or partial response is defined as the time interval between the date of the earliest qualifying response and the date of progressive disease or death for any cause, whichever occurs earlier as determined by Investigator per RECIST version 1.1. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and other tumor types. | The Safety Analysis Set (SAS) included all participants who received ≥ 1 dose of tislelizumab; one participant is included in both MSI-H/dMMR and GC indications. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 years and 5 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Indication Expansion: Clinical Benefit Rate | Clinical benefit rate is defined as the percentage of participants in specific tumor types reaching confirmed CR, PR and durable stable disease (SD; at ≥ 24 weeks) in accordance with RECIST version 1.1. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and other tumor types. | The Safety Analysis Set (SAS) included all participants who received ≥ 1 dose of tislelizumab; one participant is included in both MSI-H/dMMR and GC indications. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 3 years and 5 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Indication Expansion: Overall Survival | Overall survival is defined as the time from the date of the first study dose to death. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and other tumor types. | The Safety Analysis Set (SAS) included all participants who received ≥ 1 dose of tislelizumab; one participant is included in both MSI-H/dMMR and GC indications. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 3 years and 5 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Indication Expansion: Disease Control Rate | Disease control rate is defined as the percentage of participants reaching CR, PR, and SD according to RECIST version 1.1. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and other tumor types. | The Safety Analysis Set (SAS) included all participants who received ≥ 1 dose of tislelizumab; one participant is included in both MSI-H/dMMR and GC indications. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 3 years and 5 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-drug Antibody (ADA) Status to Tislelizumab | Evaluable participants had non-missing baseline ADA and at least 1 non-missing postbaseline ADA result. | Posted | Count of Participants | Participants | No | Up to approximately 23 months |
|
|
Up to 30 days after the last dose of study treatment; Up to approximately 3 years and 5 months
All AEs will be recorded during the study (AE from the time of the first dose and SAEs from the time of signing of informed consent) and for up to 30 days after the last dose of study treatment or until the initiation of another anticancer therapy, whichever occurs first.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tislelizumab | Tislelizumab 200 mg was administered intravenously (IV) once every 3 weeks (21 days per cycle) until no evidence of continued clinical benefits, unacceptable toxicity, or withdrawal of informed consent at the discretion of the investigator. Safety analysis data are summarized for the overall population given that the same dose was applied, regardless of part assignment, as pre-specified in the clinical study report. | 202 | 300 | 85 | 300 | 277 | 300 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | meddra 23.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | meddra 23.0 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | meddra 23.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | meddra 23.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | meddra 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Death | General disorders | meddra 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | meddra 23.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | meddra 23.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | meddra 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | meddra 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 23.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | meddra 23.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | meddra 23.0 | Systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | meddra 23.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | meddra 23.0 | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | meddra 23.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | meddra 23.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | meddra 23.0 | Systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | meddra 23.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | meddra 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 23.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | meddra 23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | meddra 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | meddra 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra 23.0 | Systematic Assessment |
| |
| Anastomotic fistula | Injury, poisoning and procedural complications | meddra 23.0 | Systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | meddra 23.0 | Systematic Assessment |
| |
| Anastomotic stenosis | Injury, poisoning and procedural complications | meddra 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | meddra 23.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | meddra 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | meddra 23.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | meddra 23.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | meddra 23.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | meddra 23.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | meddra 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra 23.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 23.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | meddra 23.0 | Systematic Assessment |
| |
| Cerebral artery embolism | Nervous system disorders | meddra 23.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | meddra 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra 23.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | meddra 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | meddra 23.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | meddra 23.0 | Systematic Assessment |
| |
| Paralysis | Nervous system disorders | meddra 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | meddra 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | meddra 23.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | meddra 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | meddra 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 23.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | meddra 23.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | meddra 23.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | meddra 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | meddra 23.0 | Systematic Assessment |
| |
| Malaise | General disorders | meddra 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | meddra 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | meddra 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Protein urine present | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Red blood cells urine positive | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Weight increased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | meddra 23.0 | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | meddra 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | meddra 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | meddra 23.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | meddra 23.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | meddra 23.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | meddra 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | meddra 23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | meddra 23.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | meddra 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | meddra 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra 23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra 23.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | meddra 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | meddra 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | meddra 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | meddra 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra 23.0 | Systematic Assessment |
|
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2018 | Apr 20, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
Not provided
Not provided
Not provided
| Other not specified |
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| Serious adverse event |
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| Title | Denominators | Categories | ||||
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| Treatment-emergent |
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| Treatment-boosted |
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| Treatment-induced |
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