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
NCT ID: NCT04693234
Last Updated: 2025-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
178 participants
INTERVENTIONAL
2021-02-15
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Ociperlimab + Tislelizumab
Tislelizumab 200 milligrams (mg) intravenously (IV) once every 3 weeks (Q3W) combined with ociperlimab (BGB-A1217) 900 mg IV Q3W
Tislelizumab
200 mg administered intravenously once every 3 weeks on day 1 of each cycle
Ociperlimab
900 mg administered intravenously once every 3 weeks on day 1 of each cycle
Cohort 2: Tislelizumab
Tislelizumab 200 mg IV Q3W monotherapy
Tislelizumab
200 mg administered intravenously once every 3 weeks on day 1 of each cycle
Interventions
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Tislelizumab
200 mg administered intravenously once every 3 weeks on day 1 of each cycle
Ociperlimab
900 mg administered intravenously once every 3 weeks on day 1 of each cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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).
3. 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.
4. 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).
5. Participant must have adequate organ function as indicated by the screening laboratory values obtained within 7 days before the first study treatment.
Exclusion Criteria
2. 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).
3. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks of intervention).
4. 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.
5. 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.
18 Years
FEMALE
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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"Mhat uni hospital" ood
Panagyurishte, , Bulgaria
Complex Oncology Center Rousse Eood
Rousse, , Bulgaria
Medical center nadezhda clinical eood
Sofia, , Bulgaria
Acibadem city clinic tokuda umhat ead, department of medical oncology
Sofia, , Bulgaria
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Southwest Hospital
Chongqing, Chongqing Municipality, China
Gansu Provincial Hospital
Lanzhou, Gansu, China
Sun yat-sen memorial hospital, sun yat-sen university (south)
Guanzhou, Guangdong, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China
Hainan Cancer Hospital
Haikou, Hainan, China
Henan Cancer Hospital - Oncology
Zhengzhou, Henan, China
Hubei Cancer Hospital - Oncology
Wuhan, Hubei, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital - GCP Office
Changsha, Hunan, China
Xuzhou Cancer Hospital
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Jilin Guowen Hospital
Jilin, Jilin, China
Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Second Hospital Of Shanxi Medical University
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Tianjin Medical University Cancer institute & Hospital
Tianjin, Tianjin Municipality, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Beijing Cancer Hosptial
Beijing, , China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, , China
Linyi Cancer Hospital
Shandong, , China
The First Affiliated Hospital of Xiamen University - Oncology
Xiamen, , China
Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością
Gdynia, , Poland
Przychodnia lekarska komed
Konin, , Poland
State healthcare institution oncologic dispensary no. 2 - health department of krasnodar region
Krasnodar, Krasnodarskiy Kray, Russia
Fsbi of higher education"ogarev mordovia state university"
Saransk, Mordovia Republic, Russia
Oncological Scientific Center LLC
Pesochny, Sankt-Peterburg, 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, , Russia
Keimyung University Dongsan Medical Center
Daegu, , 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 City, , Taiwan
Linkou Chang Gung Memorial Hospital
Tainan City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Siriraj Hospital
Bangkok Noi, Bangkok, Thailand
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, , Thailand
Srinagarind Hospital (Khon Kaen University)
Khon Kaen, , Thailand
Phramongkutklao Hospital
Ratchathewi, , Thailand
Public Non-Profit Institution "Precarpathian Oncology Center Of Ivano-Frankivsk Regional Council"
Ivano-Frankivsk Oblast, Ivano-Frankivsk Oblast, Ukraine
Medical and diagnostic center of private enterprise private production company "acinus"
Kirovograd, Kirovohrad Oblast, Ukraine
Communal Non-Profit Enterprise Of Sumy Regional Council Sumy Regional Clinical Oncological Dispensar
Sumy, Sumska Oblast, Ukraine
National Cancer Institute
Kiev, , Ukraine
Medical center of llc oncolife
Kropyvnytskyi, , Ukraine
Volyn Regional Medical Center Of Oncology
Lutsk, , Ukraine
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-004657-77
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AdvanTIG-202
Identifier Type: OTHER
Identifier Source: secondary_id
CTR20212809
Identifier Type: OTHER
Identifier Source: secondary_id
CTR20210588
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-A317-A1217-202
Identifier Type: -
Identifier Source: org_study_id
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