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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004657-77 | EudraCT Number | ||
| AdvanTIG-202 | Other Identifier | BeiGene | |
| CTR20212809 | Other Identifier | ChinaDrugTrials | |
| CTR20210588 | Other Identifier | ChinaDrugTrials |
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This study tested how well and how safely the drug tislelizumab, given either alone or with another drug called ociperlimab (BGB-A1217), worked in people with cervical cancer that had come back or spread after previous treatments. The study included two groups and took place at multiple medical centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Ociperlimab + Tislelizumab | Experimental | Tislelizumab 200 milligrams (mg) intravenously (IV) once every 3 weeks (Q3W) combined with ociperlimab (BGB-A1217) 900 mg IV Q3W |
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| Cohort 2: Tislelizumab | Experimental | Tislelizumab 200 mg IV Q3W monotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Biological | 200 mg administered intravenously once every 3 weeks on day 1 of each cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Objective Response Rate (ORR) Assessed by an Independent Review Committee (IRC) in PD-L1-Positive Participants | ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the IRC per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). PD-L1-positive refers to participants whose tumors had a PD-L1 TAP score ≥ 5%. | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1. |
| Cohort 1: ORR Assessed by the IRC in All Treated Participants | ORR is defined as the percentage of participants who had a confirmed CR or PR as assessed by the IRC per RECIST v1.1. | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 2: Objective Response Rate (ORR) Assessed by an Independent Review Committee in All Treated Participants | ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the IRC per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 10.40 months for Cohort 2. |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| "Mhat uni hospital" ood | Panagyurishte | 4500 | Bulgaria | |||
| Complex Oncology Center Rousse Eood |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Wu L, Wang PH, Hsiao SY, et al. AdvanTIG-202: A phase 2 study investigating anti-T cell immunoglobulin and ITIM domain monoclonal antibody ociperlimab plus tislelizumab in patients with previously treated recurrent or metastatic cervical cancer (333). Gynecol Oncol. 2022;166:S172. doi:10.1016/S0090-8258(22)01555-4 | ||
| 40411966 | Derived | Lee JY, Boonyapipat S, Yuan G, Kim HS, Lee JW, Wang L, Wang T, Wang D, Yao D, Liu H, Chang CL, Andabekov TT, Zhang X, Wang W, Kim YM, Sinielnikov IV, Wang K, Gao Y, Mu X, Wu L. AdvanTIG-202: Phase 2 open-label, two-cohort multicenter study of ociperlimab plus tislelizumab and tislelizumab alone in patients with previously treated recurrent or metastatic cervical cancer. Gynecol Oncol. 2025 Jul;198:25-32. doi: 10.1016/j.ygyno.2025.04.579. Epub 2025 May 23. |
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The study was composed of an initial screening phase (up to 28 days), a treatment phase, an end of treatment visit, an on-site Safety Follow-up Visit, and 2 Safety Follow-up Visits by telephone after the last dose of study treatment.
Participants were enrolled in multiple study centers in China, South Korea, and Europe.The first participant dosed was on March 3rd, 2021 and the last participant completed on August 31st, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Ociperlimab + Tislelizumab | Participants received tislelizumab 200 milligrams (mg) intravenously (IV) and ociperlimab 900 mg IV once every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or withdrawal of consent. |
| FG001 | Cohort 2: Tislelizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | May 4, 2023 | Aug 22, 2024 |
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| Ociperlimab | Biological | 900 mg administered intravenously once every 3 weeks on day 1 of each cycle |
|
|
| ORR Assessed by the Investigator in PD-L1-Positive Participants | ORR is defined as the percentage of participants who had confirmed CR or PR as assessed by the investigator per RECIST v1.1 in the PD-L1 Score >= 5% Safety Analysis Set. | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
| ORR as Assessed by the Investigator in All Treated Participants | ORR is defined as the percentage of participants who had a confirmed CR or PR as assessed by the investigator per RECIST v1.1. | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
| Duration of Response (DOR) Assessed by the IRC | DOR is defined as the time from the first confirmed objective response until the first documentation of progression or death, whichever occurred first, assessed by the IRC according to RECIST v1.1 in the Safety Analysis Set. | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
| Duration of Response (DOR) Assessed by the Investigator | DOR is defined as the time from the first confirmed objective response until the first documentation of progression or death, whichever comes first, assessed by the investigator according to RECIST v1.1 in the Safety Analysis Set. Data was based on number of responders. | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
| Progression Free Survival (PFS) | Defined as the time from the date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurred first as assessed by both the IRC and the investigator's review per RECIST v1.1 in the Safety Analysis Set. | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
| Time to Response (TTR) Assessed by the IRC | TTR is defined as the time from the date of first dose of study drug to the first documentation of response as assessed by the IRC per RECIST v1.1, in the Safety Analysis Set. | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
| Time to Response (TTR) Assessed by the Investigator | TTR is defined as the time from the date of first dose of study drug to the first documentation of response as assessed by the investigator per RECIST v1.1, in the Safety Analysis Set. | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
| Disease Control Rate (DCR) | DCR is defined as the percentage of participants who achieve CR, PR, or stable disease (SD) as assessed by both the IRC and investigator per RECIST v1.1 in the Safety Analysis Set. | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
| Clinical Benefit Rate (CBR) | Defined as the percentage of participants who achieve CR, PR, or durable SD (SD ≥ 24 weeks) as assessed by both the IRC and investigator per RECIST v1.1 in the Safety Analysis Set. | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
| Overall Survival (OS) | Overall survival is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology. | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
| Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life, Physical Functioning, and Pain Scores | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. Lower scores in symptom scales indicate better quality of life. | Baseline to Cycles 3 and 5 ( Each cycle was 21 days) |
| Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Index Score | QLQ-CX24 is the cervical cancer module of the QLQ-C30. CX24 is comprised of 24 questions grouped into 3 symptom scales and 6 single symptom items. Each question is answered on a scale from 1 (not at all) to 4 (very much). The scales include Symptom Experience (11 items), Body Image (3 items) and Sexual/vaginal Functioning (4 items). The single symptom items include Lymphedema, Peripheral Neuropathy, Menopausal Symptoms, Sexual Worry, Sexual Activity and Sexual Enjoyment. Raw scores are transformed into a 0 to 100 scale via linear transformation. The Index score is calculated as the average of the 3 symptom scales and 6 single item scores. Lower scores indicate better HRQoL. | Baseline to Cycles 3 and 5 ( Each cycle was 21 days) |
| Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether considered related to study drugs or not. An SAE is any untoward medical occurrence that, at any dose:
| From the first dose of study drug to 30 days after the last dose; maximum treatment exposure was 23.5 months. |
| Serum Ociperlimab (BGB-A1217) Concentrations at Specified Timepoints | The timepoints are defined as predose (within 60 minutes before starting infusion) and postdose (within 30 minutes after the end of infusion). | Day 1 of Cycles 1, 2, 5, 9, and 17 (each cycle was 21 days) |
| Serum Tislelizumab Concentrations at Specified Timepoints | The timepoints are defined as predose (within 60 minutes before starting infusion) and postdose (within 30 minutes after the end of infusion). | Day 1 of Cycles 1, 2, 5, 9, and 17 (each cycle is 21 days) |
| Number of Participants Who Developed Positive Anti-drug Antibodies (ADAs) to Ociperlimab | Number and percentage of participants who developed detectable ADAs to ociperlimab during the treatment period. | Samples for ADA analysis were collected predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at the Safety Follow-up Visit (30 days after last dose) up to the immunogenicity data cut-off date of June 1, 2023 (approximately 21 months). |
| Number of Participants Who Developed Anti-drug Antibodies (ADAs) to Tislelizumab | Number and percentage of participants who developed detectable ADAs during the treatment period. | Samples for ADA analysis were collected predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at the Safety Follow-up Visit (30 days after last dose), up to the immunogenicity data cut-off date of June 1, 2023 (approximately 21 months). |
| Rousse |
| 7002 |
| Bulgaria |
| Medical center nadezhda clinical eood | Sofia | 13330 | Bulgaria |
| Acibadem city clinic tokuda umhat ead, department of medical oncology | Sofia | 1407 | Bulgaria |
| Anhui Provincial Cancer Hospital | Hefei | Anhui | 230088 | China |
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | 400030 | China |
| Southwest Hospital | Chongqing | Chongqing Municipality | 400038 | China |
| Gansu Provincial Hospital | Lanzhou | Gansu | 730000 | China |
| Sun yat-sen memorial hospital, sun yat-sen university (south) | Guanzhou | Guangdong | 510275 | China |
| The Tumor Hospital Affiliated to Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| Hainan Cancer Hospital | Haikou | Hainan | 570312 | China |
| Henan Cancer Hospital - Oncology | Zhengzhou | Henan | 450008 | China |
| Hubei Cancer Hospital - Oncology | Wuhan | Hubei | 400037 | China |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Hunan Cancer Hospital - GCP Office | Changsha | Hunan | 410013 | China |
| Xuzhou Cancer Hospital | Xuzhou | Jiangsu | 221005 | China |
| The First Affiliated Hospital of Nanchang University Branch Donghu | Nanchang | Jiangxi | 330006 | China |
| Jilin Guowen Hospital | Jilin City | Jilin | 136100 | China |
| Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology | Shenyang | Liaoning | 110017 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
| Obstetrics and Gynecology Hospital of Fudan University | Shanghai | Shanghai Municipality | China |
| Second Hospital Of Shanxi Medical University | Taiyuan | Shanxi | 030013 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | 710000 | China |
| Tianjin Medical University Cancer institute & Hospital | Tianjin | Tianjin Municipality | 300070 | China |
| Affiliated Cancer Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830000 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Beijing Cancer Hosptial | Beijing | China |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | China |
| Linyi Cancer Hospital | Shandong | 276002 | China |
| The First Affiliated Hospital of Xiamen University - Oncology | Xiamen | 361005 | China |
| Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością | Gdynia | Poland |
| Przychodnia lekarska komed | Konin | 62-500 | Poland |
| State healthcare institution oncologic dispensary no. 2 - health department of krasnodar region | Krasnodar | Krasnodarskiy Kray | 350015 | Russia |
| Fsbi of higher education"ogarev mordovia state university" | Saransk | Mordovia Republic | 430005 | Russia |
| Oncological Scientific Center LLC | Pesochny | Sankt-Peterburg | 197758 | Russia |
| Sbhi of stavropol region "pyatigorsk interdistrict oncologic dispensary" | Pyatigorsk | Stavropol Kray | Russia |
| Arkhangelsk regional clinical oncological dispensary | Arkhangelsk | Russia |
| State budgetary healthcare institution-chelyabinsk regional clinical center of oncology and nuclear | Chelyabinsk | 454087 | Russia |
| Keimyung University Dongsan Medical Center | Daegu | 42601 | South Korea |
| Kyemyung University Dongsan Hospital | Daegu | South Korea |
| Ajou University Hospital | Gyeonggi-do | South Korea |
| National Cancer Center | Gyeonggi-do | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Korea Institute of Radiological & Medical Sciences | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
| Chi Mei Hospital, Liouying | Tainan | Taiwan |
| Linkou Chang Gung Memorial Hospital | Tainan | Taiwan |
| National Cheng Kung University Hospital | Tainan | Taiwan |
| Mackay Memorial Hospital | Taipei | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Siriraj Hospital | Bangkok Noi | Bangkok | 10700 | Thailand |
| Songklanagarind Hospital, Prince of Songkla University | Hat Yai | Thailand |
| Srinagarind Hospital (Khon Kaen University) | Khon Kaen | 40002 | Thailand |
| Phramongkutklao Hospital | Ratchathewi | 10400 | Thailand |
| Public Non-Profit Institution "Precarpathian Oncology Center Of Ivano-Frankivsk Regional Council" | Ivano-Frankivsk Oblast | Ivano-Frankivsk Oblast | 00000 | Ukraine |
| Medical and diagnostic center of private enterprise private production company "acinus" | Kirovograd | Kirovohrad Oblast | 25006 | Ukraine |
| Communal Non-Profit Enterprise Of Sumy Regional Council Sumy Regional Clinical Oncological Dispensar | Sumy | Sumska Oblast | 40022 | Ukraine |
| National Cancer Institute | Kiev | 3022 | Ukraine |
| Medical center of llc oncolife | Kropyvnytskyi | 25006 | Ukraine |
| Volyn Regional Medical Center Of Oncology | Lutsk | 03322 | Ukraine |
Participants received tislelizumab 200 mg administered intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. |
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| NOT COMPLETED |
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The Safety Analysis Set is defined as all participants who received >= 1 dose of any study drug for each cohort.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Ociperlimab + Tislelizumab | Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. |
| BG001 | Cohort 2: Tislelizumab | Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Eastern Cooperative Oncology Group Performance Status | The ECOG scale assesses disease status from 0 to 5. A score of 0 means fully active with no restrictions, while 1 indicates limitations in strenuous activities but the ability to do light work. Score 2 signifies ambulatory and capable of self-care, yet unable to work, being active for over 50% of waking hours. Score 3 reflects limited self-care, confined to bed or a chair for more than half the day. Score 4 indicates complete disability, with the participant fully bedbound, and score 5 means deceased. | Count of Participants | Participants |
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| Programmed Death-Ligand 1 (PD-L1) Expression | PD-L1 is a protein found in higher-than-normal amounts on some types of cancer cells which can prevent the body's immune cells from killing the PD-L1-containing cancer cells. PD-L1 score was defined by the total percentage of the tumor area (tumor and any desmoplastic stroma) covered by tumor cells and tumor-associated immune cells with PD-L1 staining at any intensity as visually estimated based on Tumor Area Positive [TAP] Score methodology. (TAP score methodology had been previously referred to as the visually-estimated Combined Positive Score [vCPS] score). | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Cohort 1: Objective Response Rate (ORR) Assessed by an Independent Review Committee (IRC) in PD-L1-Positive Participants | ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the IRC per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). PD-L1-positive refers to participants whose tumors had a PD-L1 TAP score ≥ 5%. | The PD-L1 Score ≥ 5% Safety Analysis Set includes all treated participants whose tumors had PD-L1 TAP Score ≥ 5%. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1. |
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| Primary | Cohort 1: ORR Assessed by the IRC in All Treated Participants | ORR is defined as the percentage of participants who had a confirmed CR or PR as assessed by the IRC per RECIST v1.1. | The Safety Analysis Set includes all participants who received at least 1 dose of any study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1. |
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| Secondary | Cohort 2: Objective Response Rate (ORR) Assessed by an Independent Review Committee in All Treated Participants | ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the IRC per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). | The Safety Analysis Set includes all participants who received at least 1 dose of any study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 10.40 months for Cohort 2. |
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| Secondary | ORR Assessed by the Investigator in PD-L1-Positive Participants | ORR is defined as the percentage of participants who had confirmed CR or PR as assessed by the investigator per RECIST v1.1 in the PD-L1 Score >= 5% Safety Analysis Set. | The PD-L1 Score ≥ 5% Safety Analysis Set includes all treated participants whose tumors had PD-L1 Score ≥ 5%. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
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| Secondary | ORR as Assessed by the Investigator in All Treated Participants | ORR is defined as the percentage of participants who had a confirmed CR or PR as assessed by the investigator per RECIST v1.1. | The Safety Analysis Set includes participants who received at least 1 dose of any study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
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| Secondary | Duration of Response (DOR) Assessed by the IRC | DOR is defined as the time from the first confirmed objective response until the first documentation of progression or death, whichever occurred first, assessed by the IRC according to RECIST v1.1 in the Safety Analysis Set. | Safety Analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 by the IRC were included in the analysis | Posted | Median | 95% Confidence Interval | Months | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
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| Secondary | Duration of Response (DOR) Assessed by the Investigator | DOR is defined as the time from the first confirmed objective response until the first documentation of progression or death, whichever comes first, assessed by the investigator according to RECIST v1.1 in the Safety Analysis Set. Data was based on number of responders. | Safety Analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 by the investigator were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
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| Secondary | Progression Free Survival (PFS) | Defined as the time from the date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurred first as assessed by both the IRC and the investigator's review per RECIST v1.1 in the Safety Analysis Set. | Safety Analysis Set | Posted | Median | 95% Confidence Interval | Months | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
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| Secondary | Time to Response (TTR) Assessed by the IRC | TTR is defined as the time from the date of first dose of study drug to the first documentation of response as assessed by the IRC per RECIST v1.1, in the Safety Analysis Set. | The Safety Analysis Set. Only participants with best overall response of complete response or partial response confirmed by the IRC per RECIST v1.1 were included in the analysis. | Posted | Mean | Standard Deviation | Weeks | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
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| Secondary | Time to Response (TTR) Assessed by the Investigator | TTR is defined as the time from the date of first dose of study drug to the first documentation of response as assessed by the investigator per RECIST v1.1, in the Safety Analysis Set. | The Safety Analysis Set. Only participants with best overall response of complete response or partial response confirmed by the investigator per RECIST v1.1 were included in the analysis. | Posted | Mean | Standard Deviation | Weeks | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
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| Secondary | Disease Control Rate (DCR) | DCR is defined as the percentage of participants who achieve CR, PR, or stable disease (SD) as assessed by both the IRC and investigator per RECIST v1.1 in the Safety Analysis Set. | The Safety Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
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| Secondary | Clinical Benefit Rate (CBR) | Defined as the percentage of participants who achieve CR, PR, or durable SD (SD ≥ 24 weeks) as assessed by both the IRC and investigator per RECIST v1.1 in the Safety Analysis Set. | The Safety Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
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| Secondary | Overall Survival (OS) | Overall survival is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology. | The Safety Analysis Set | Posted | Median | 95% Confidence Interval | Months | Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2. |
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| Secondary | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life, Physical Functioning, and Pain Scores | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. Lower scores in symptom scales indicate better quality of life. | The Safety Analysis Set with available EORTC QLQ-C30 values at Baseline; Only participants with data at baseline and at each time point are included. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Cycles 3 and 5 ( Each cycle was 21 days) |
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| Secondary | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Index Score | QLQ-CX24 is the cervical cancer module of the QLQ-C30. CX24 is comprised of 24 questions grouped into 3 symptom scales and 6 single symptom items. Each question is answered on a scale from 1 (not at all) to 4 (very much). The scales include Symptom Experience (11 items), Body Image (3 items) and Sexual/vaginal Functioning (4 items). The single symptom items include Lymphedema, Peripheral Neuropathy, Menopausal Symptoms, Sexual Worry, Sexual Activity and Sexual Enjoyment. Raw scores are transformed into a 0 to 100 scale via linear transformation. The Index score is calculated as the average of the 3 symptom scales and 6 single item scores. Lower scores indicate better HRQoL. | The Safety Analysis Set with available EORTC QLQ-CX24 values at Baseline; Only participants with data at baseline and at each time point are included. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Cycles 3 and 5 ( Each cycle was 21 days) |
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| Secondary | Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether considered related to study drugs or not. An SAE is any untoward medical occurrence that, at any dose:
| The Safety Analysis Set includes all participants who received at least 1 dose of any study drug. | Posted | Count of Participants | Participants | From the first dose of study drug to 30 days after the last dose; maximum treatment exposure was 23.5 months. |
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| Secondary | Serum Ociperlimab (BGB-A1217) Concentrations at Specified Timepoints | The timepoints are defined as predose (within 60 minutes before starting infusion) and postdose (within 30 minutes after the end of infusion). | The Pharmacokinetic Analysis (PK) Set includes all participants who received at least 1 dose of any component of study drug per the protocol, for whom any post-dose PK data are available. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 1 of Cycles 1, 2, 5, 9, and 17 (each cycle was 21 days) |
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| Secondary | Serum Tislelizumab Concentrations at Specified Timepoints | The timepoints are defined as predose (within 60 minutes before starting infusion) and postdose (within 30 minutes after the end of infusion). | The Pharmacokinetic Analysis Set includes all participants who received >= 1 dose of any component of study drug per the protocol, for whom any post-dose PK data are available. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 1 of Cycles 1, 2, 5, 9, and 17 (each cycle is 21 days) |
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| Secondary | Number of Participants Who Developed Positive Anti-drug Antibodies (ADAs) to Ociperlimab | Number and percentage of participants who developed detectable ADAs to ociperlimab during the treatment period. | The ADA Analysis Set includes all participants who received at least 1 dose of any component of study drug for whom both baseline antidrug antibody result and at least 1 post-baseline antidrug antibody result were available. | Posted | Count of Participants | Participants | Samples for ADA analysis were collected predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at the Safety Follow-up Visit (30 days after last dose) up to the immunogenicity data cut-off date of June 1, 2023 (approximately 21 months). |
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| Secondary | Number of Participants Who Developed Anti-drug Antibodies (ADAs) to Tislelizumab | Number and percentage of participants who developed detectable ADAs during the treatment period. | The ADA Analysis Set includes all participants who received at least 1 dose of any component of study drug for whom both baseline antidrug antibody result and at least 1 post-baseline antidrug antibody result are available. | Posted | Count of Participants | Participants | Samples for ADA analysis were collected predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at the Safety Follow-up Visit (30 days after last dose), up to the immunogenicity data cut-off date of June 1, 2023 (approximately 21 months). |
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|
All-cause mortality: From randomization through the end of study; up to 24.5 months. Adverse events: From the first dose to 30 days after the last dose; maximum treatment exposure was 23.5 months.
Not provided
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 | Cohort 1: Ociperlimab + Tislelizumab | Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. | 79 | 138 | 61 | 138 | 128 | 138 |
| EG001 | Cohort 2: Tislelizumab | Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. | 19 | 40 | 17 | 40 | 37 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute hepatitis C | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Retroperitoneal abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Tumour thrombosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urogenital fistula | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Genital swelling | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Thyroxine free increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 24.0 | 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 | May 6, 2022 | Aug 22, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
Not provided
Not provided
Not provided
| White |
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| South Korea |
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| Taiwan |
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| Ukraine |
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| Russia |
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| Thailand |
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| Bulgaria |
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| Poland |
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| 1 |
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| PD-L1 Score < 5% |
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| Not Evaluable |
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| Participants |
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| Cohort 2: Tislelizumab |
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. |
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| Cohort 2 (Postdose) |
Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion. |
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