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

Last updated: April 9, 2025
Sponsor: BeiGene
Overall Status: Completed

Phase

2

Condition

Vaginal Cancer

Pelvic Cancer

Uterine Disorders

Treatment

Ociperlimab

Ociperlimab

Tislelizumab

Clinical Study ID

NCT04693234
BGB-A317-A1217-202
2020-004657-77
CTR20212809
AdvanTIG-202
CTR20210588
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically or cytologically confirmed squamous cell carcinoma, adenosquamouscarcinoma, or adenocarcinoma of the cervix.

  2. Progression on or after one or more lines of chemotherapy for management ofrecurrent 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 subjectedto prior loco-regional therapy, including previous radiotherapy, is not consideredmeasurable unless there has been demonstrated progression in the lesion since thetherapy as defined by RECIST v1.1.

  4. Participants must submit qualified archival tumor tissue (formalin-fixedparaffin-embedded block containing tumor [preferred] or approximately 15 [at least 6] unstained slides) with an associated pathology report, or agree to a tumor biopsyfor determination of Programmed death-ligand 1 (PD-L1) expression and otherbiomarker analyses (fresh tumor biopsies are strongly recommended at baseline inparticipants with readily accessible tumor lesions and who consent to the biopsies).

  5. Participant must have adequate organ function as indicated by the screeninglaboratory values obtained within 7 days before the first study treatment.

Exclusion

Exclusion Criteria:

  1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT or any other antibodyor drug specifically targeting T-cell costimulation or checkpoint pathways.

  2. Any active malignancy ≤ 2 years before first dose of study drug except for thespecific cancer under investigation in this study and any locally recurring cancerthat 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 frequentdrainage (recurrence within 2 weeks of intervention).

  4. Any major surgical procedure ≤ 28 days before first dose of study drug. Participantsmust have recovered adequately from the toxicity and/or complications from theintervention 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 islonger) before the first dose of study drug or has received palliative radiationtreatment or other local regional therapies within 14 days before the first dose ofstudy drug.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Total Participants: 178
Treatment Group(s): 4
Primary Treatment: Ociperlimab
Phase: 2
Study Start date:
February 15, 2021
Estimated Completion Date:
August 31, 2023

Connect with a study center

  • "Mhat uni hospital" ood

    Panagyurishte, 4500
    Bulgaria

    Site Not Available

  • Complex Oncology Center Rousse Eood

    Ruse, 7002
    Bulgaria

    Site Not Available

  • Acibadem city clinic tokuda umhat ead, department of medical oncology

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Medical center nadezhda clinical eood

    Sofia, 13330
    Bulgaria

    Site Not Available

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui 230088
    China

    Site Not Available

  • Chongqing Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Site Not Available

  • Southwest Hospital

    Chongqing, Chongqing 400038
    China

    Site Not Available

  • Gansu Provincial Hospital

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • Sun yat-sen memorial hospital, sun yat-sen university (south)

    Guanzhou, Guangdong 510275
    China

    Site Not Available

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Hainan Cancer Hospital

    Haikou, Hainan 570312
    China

    Site Not Available

  • Henan Cancer Hospital - Oncology

    Zhengzhou, Henan 450008
    China

    Site Not Available

  • Hubei Cancer Hospital - Oncology

    Wuhan, Hubei 400037
    China

    Site Not Available

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Hunan Cancer Hospital - GCP Office

    Changsha, Hunan 410013
    China

    Site Not Available

  • Xuzhou Cancer Hospital

    Xuzhou, Jiangsu 221005
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Jilin Guowen Hospital

    Jilin, Jilin 136100
    China

    Site Not Available

  • Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology

    Shenyang, Liaoning 110017
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia 750004
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

  • Obstetrics and Gynecology Hospital of Fudan University

    Shanghai, Shanghai
    China

    Site Not Available

  • Second Hospital Of Shanxi Medical University

    Taiyuan, Shanxi 030013
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi 710000
    China

    Site Not Available

  • Tianjin Medical University Cancer institute & Hospital

    Tianjin, Tianjin 300070
    China

    Site Not Available

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Urumqi, Xinjiang 830000
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • Beijing Cancer Hosptial

    Beijing,
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing,
    China

    Site Not Available

  • Linyi Cancer Hospital

    Shandong, 276002
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University - Oncology

    Xiamen, 361005
    China

    Site Not Available

  • Keimyung University Dongsan Medical Center

    Daegu, 42601
    Korea, Republic of

    Site Not Available

  • Kyemyung University Dongsan Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Gyeonggi-do,
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Gyeonggi-do,
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Gyeonggi-do,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Gangnam Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea Institute of Radiological & Medical Sciences

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul,
    Korea, Republic of

    Site Not Available

  • Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością

    Gdynia,
    Poland

    Site Not Available

  • Przychodnia lekarska komed

    Konin, 62-500
    Poland

    Site Not Available

  • State healthcare institution oncologic dispensary no. 2 - health department of krasnodar region

    Krasnodar, Krasnodar Krai 350015
    Russian Federation

    Site Not Available

  • Fsbi of higher education"ogarev mordovia state university"

    Saransk, Mordovia Republic 430005
    Russian Federation

    Site Not Available

  • Oncological Scientific Center LLC

    Pesochny, Saint Petersburg 197758
    Russian Federation

    Site Not Available

  • Sbhi of stavropol region "pyatigorsk interdistrict oncologic dispensary"

    Pyatigorsk, Stavropol Region
    Russian Federation

    Site Not Available

  • Arkhangelsk regional clinical oncological dispensary

    Arkhangel'sk,
    Russian Federation

    Site Not Available

  • State budgetary healthcare institution-chelyabinsk regional clinical center of oncology and nuclear

    Chelyabinsk, 454087
    Russian Federation

    Site Not Available

  • Chi Mei Hospital, Liouying

    Tainan,
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital

    Tainan,
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan,
    Taiwan

    Site Not Available

  • Mackay Memorial Hospital

    Taipei,
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Siriraj Hospital

    Bangkok Noi, Bangkok 10700
    Thailand

    Site Not Available

  • Songklanagarind Hospital, Prince of Songkla University

    Hat Yai,
    Thailand

    Site Not Available

  • Srinagarind Hospital (Khon Kaen University)

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Phramongkutklao Hospital

    Ratchathewi, 10400
    Thailand

    Site Not Available

  • Public Non-Profit Institution "Precarpathian Oncology Center Of Ivano-Frankivsk Regional Council"

    Ivano-Frankivsk Oblast, Ivano-Frankivsk 00000
    Ukraine

    Site Not Available

  • Medical and diagnostic center of private enterprise private production company "acinus"

    Kirovograd, Kirovohradska Oblast 25006
    Ukraine

    Site Not Available

  • Communal Non-Profit Enterprise Of Sumy Regional Council Sumy Regional Clinical Oncological Dispensar

    Sumy, Sumska Oblast 40022
    Ukraine

    Site Not Available

  • National Cancer Institute

    Kiev, 3022
    Ukraine

    Site Not Available

  • Medical center of llc oncolife

    Kropyvnytskyi, 25006
    Ukraine

    Site Not Available

  • Volyn Regional Medical Center Of Oncology

    Luts'k, 03322
    Ukraine

    Site Not Available

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