Cervical CancerPhase 2NCT04693234
AdvanTIG-202: Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Previously Treated Recurrent or Metastatic Cervical Cancer
A Phase 2 study testing Tislelizumab and Ociperlimab in people with Cervical Cancer, run by BeiGene at 68 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Tislelizumab and Ociperlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 68 sitesin 8 countries
- Study dates
- 15 Feb 2021to 31 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.
- Progression on or after one or more lines of chemotherapy for management of recurrent or metastatic disease and is not amenable to curative treatment (eg, systemic chemotherapy, surgery, or radiotherapy).
- Measurable disease as assessed by RECIST v1.1. Note: A lesion in an area subjected to prior loco-regional therapy, including previous radiotherapy, is not considered measurable unless there has been demonstrated progression in the lesion since the therapy as defined by RECIST v1.1.
- Participants must submit qualified archival tumor tissue (formalin-fixed paraffin-embedded block containing tumor [preferred] or approximately 15 [at least 6] unstained slides) with an associated pathology report, or agree to a tumor biopsy for determination of Programmed death-ligand 1 (PD-L1) expression and other biomarker analyses (fresh tumor biopsies are strongly recommended at baseline in participants with readily accessible tumor lesions and who consent to the biopsies).
- Participant must have adequate organ function as indicated by the screening laboratory values obtained within 7 days before the first study treatment.
Who cannot join
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
- Any active malignancy ≤ 2 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of breast).
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks of intervention).
- Any major surgical procedure ≤ 28 days before first dose of study drug. Participants must have recovered adequately from the toxicity and/or complications from the intervention before the first dose of study drug.
- Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc.) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
68 sites in 8 countries.
68 sites in 8 countries
China28 sites
Beijing Cancer Hosptial
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Hunan Cancer Hospital - GCP Office
Changsha, Hunan, 410013
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Sun yat-sen memorial hospital, sun yat-sen university (south)
Guanzhou, Guangdong, 510275
Hainan Cancer Hospital
Haikou, Hainan, 570312
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230088
Jilin Guowen Hospital
Jilin City, Jilin, 136100
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Gansu Provincial Hospital
Lanzhou, Gansu, 730000
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021
Linyi Cancer Hospital
Shandong, 276002
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality
Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology
Shenyang, Liaoning, 110017
Second Hospital Of Shanxi Medical University
Taiyuan, Shanxi, 030013
Tianjin Medical University Cancer institute & Hospital
Tianjin, Tianjin Municipality, 300070
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Hubei Cancer Hospital - Oncology
Wuhan, Hubei, 400037
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710000
The First Affiliated Hospital of Xiamen University - Oncology
Xiamen, 361005
Xuzhou Cancer Hospital
Xuzhou, Jiangsu, 221005
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Henan Cancer Hospital - Oncology
Zhengzhou, Henan, 450008
South Korea12 sites
Keimyung University Dongsan Medical Center
Daegu, 42601
Kyemyung University Dongsan Hospital
Daegu
Ajou University Hospital
Gyeonggi-do
National Cancer Center
Gyeonggi-do
Seoul National University Bundang Hospital
Gyeonggi-do
Asan Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Korea Institute of Radiological & Medical Sciences
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Russia6 sites
Arkhangelsk regional clinical oncological dispensary
Arkhangelsk
State budgetary healthcare institution-chelyabinsk regional clinical center of oncology and nuclear
Chelyabinsk, 454087
State healthcare institution oncologic dispensary no. 2 - health department of krasnodar region
Krasnodar, Krasnodarskiy Kray, 350015
Oncological Scientific Center LLC
Pesochny, Sankt-Peterburg, 197758
Sbhi of stavropol region "pyatigorsk interdistrict oncologic dispensary"
Pyatigorsk, Stavropol Kray
Fsbi of higher education"ogarev mordovia state university"
Saransk, Mordovia Republic, 430005
Taiwan6 sites
Chi Mei Hospital, Liouying
Tainan
Linkou Chang Gung Memorial Hospital
Tainan
National Cheng Kung University Hospital
Tainan
Mackay Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Ukraine6 sites
Public Non-Profit Institution "Precarpathian Oncology Center Of Ivano-Frankivsk Regional Council"
Ivano-Frankivsk Oblast, Ivano-Frankivsk Oblast, 00000
National Cancer Institute
Kiev, 3022
Medical and diagnostic center of private enterprise private production company "acinus"
Kirovograd, Kirovohrad Oblast, 25006
Medical center of llc oncolife
Kropyvnytskyi, 25006
Volyn Regional Medical Center Of Oncology
Lutsk, 03322
Communal Non-Profit Enterprise Of Sumy Regional Council Sumy Regional Clinical Oncological Dispensar
Sumy, Sumska Oblast, 40022
Bulgaria4 sites
"Mhat uni hospital" ood
Panagyurishte, 4500
Complex Oncology Center Rousse Eood
Rousse, 7002
Medical center nadezhda clinical eood
Sofia, 13330
Acibadem city clinic tokuda umhat ead, department of medical oncology
Sofia, 1407
Thailand4 sites
Siriraj Hospital
Bangkok Noi, Bangkok, 10700
Songklanagarind Hospital, Prince of Songkla University
Hat Yai
Srinagarind Hospital (Khon Kaen University)
Khon Kaen, 40002
Phramongkutklao Hospital
Ratchathewi, 10400
Poland2 sites
Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością
Gdynia
Przychodnia lekarska komed
Konin, 62-500
About this study
Official title: Phase 2 Study Investigating Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody BGB-A1217 in Patients With Previously Treated Recurrent or Metastatic Cervical Cancer
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.
- Conditions
- Cervical Cancer
- Being tested
- Tislelizumab, Ociperlimab
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabBiological
Also called BGB-A317, TEVIMBRA®
200 mg administered intravenously once every 3 weeks on day 1 of each cycle
OciperlimabBiological
Also called BGB-A1217
900 mg administered intravenously once every 3 weeks on day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Tislelizumab; Biological: Ociperlimab |
| Cohort 2: Tislelizumab | Experimental | Tislelizumab 200 mg IV Q3W monotherapy Receives: Biological: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 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.
Secondary outcomes (18)
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).
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
- Resulted in death
- Was life-threatening
- Required hospitalization or prolongation of existing hospitalization
- Resulted in disability/incapacity
- Was a congenital anomaly/birth defect
- Was considered a significant medical AE by the investigator based on medical judgement (eg, may jeopardize the patient or may require medical/surgical intervention to prevent one of the outcomes listed above).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start15 Feb 2021
- Primary completion16 Jun 2022
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693234
- Sponsor's protocol ID
- BGB-A317-A1217-202
- Other IDs
- 2020-004657-77, AdvanTIG-202, CTR20212809, CTR20210588
- Status last verified
- Apr 2025
- First submitted
- 22 Dec 2020
- Last updated
- 27 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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
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.
PubMed 40411966
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Investigating Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody BGB-A1217 in Patients With Previously Treated Recurrent or Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT04693234
- Acronym / sponsor ID
- BGB-A317-A1217-202
- Conditions
- Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Posted 27 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Ociperlimab + Tislelizumab | Experimental | Biological: Tislelizumab, Biological: OciperlimabTislelizumab 200 milligrams (mg) intravenously (IV) once every 3 weeks (Q3W) combined with ociperlimab (BGB-A1217) 900 mg IV Q3W |
| Cohort 2: Tislelizumab | Experimental | Biological: TislelizumabTislelizumab 200 mg IV Q3W monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.
- Progression on or after one or more lines of chemotherapy for management of recurrent or metastatic disease and is not amenable to curative treatment (eg, systemic chemotherapy, surgery, or radiotherapy).
- Measurable disease as assessed by RECIST v1.1. Note: A lesion in an area subjected to prior loco-regional therapy, including previous radiotherapy, is not considered measurable unless there has been demonstrated progression in the lesion since the therapy as defined by RECIST v1.1.
- Participants must submit qualified archival tumor tissue (formalin-fixed paraffin-embedded block containing tumor [preferred] or approximately 15 [at least 6] unstained slides) with an associated pathology report, or agree to a tumor biopsy for determination of Programmed death-ligand 1 (PD-L1) expression and other biomarker analyses (fresh tumor biopsies are strongly recommended at baseline in participants with readily accessible tumor lesions and who consent to the biopsies).
- Participant must have adequate organ function as indicated by the screening laboratory values obtained within 7 days before the first study treatment.
Key exclusion criteria (6 listed)
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
- Any active malignancy ≤ 2 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of breast).
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks of intervention).
- Any major surgical procedure ≤ 28 days before first dose of study drug. Participants must have recovered adequately from the toxicity and/or complications from the intervention before the first dose of study drug.
- Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc.) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabAlso: BGB-A317, TEVIMBRA®200 mg administered intravenously once every 3 weeks on day 1 of each cycle | Biological | Cohort 1: Ociperlimab + Tislelizumab, Cohort 2: Tislelizumab |
| OciperlimabAlso: BGB-A1217900 mg administered intravenously once every 3 weeks on day 1 of each cycle | Biological | Cohort 1: Ociperlimab + Tislelizumab |
Primary outcome
Cohort 1: Objective Response Rate (ORR) Assessed by an Independent Review Committee (IRC) in PD-L1-Positive Participants
Time frame: 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.
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%.
Cohort 1: ORR Assessed by the IRC in All Treated Participants
Time frame: 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.
ORR is defined as the percentage of participants who had a confirmed CR or PR as assessed by the IRC per RECIST v1.1.
18 secondary outcomes
Cohort 2: Objective Response Rate (ORR) Assessed by an Independent Review Committee in All Treated Participants
Time frame: 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.
ORR Assessed by the Investigator in PD-L1-Positive Participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Day 1 of Cycles 1, 2, 5, 9, and 17 (each cycle was 21 days)
Serum Tislelizumab Concentrations at Specified Timepoints
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundWu 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
- Derived from this study: PubMed 40411966Lee 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
BeiGene
68 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab and Ociperlimab in people with Cervical Cancer, run by BeiGene at 68 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in China, South Korea, Russia, Taiwan, Ukraine and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Objective Response Rate (ORR) Assessed by an Independent Review Committee (IRC) in PD-L1-Positive Participants (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04693234, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.