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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Biological: Tislelizumab; Biological: Ociperlimab

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Panagyurishte, Bulgaria, 4500
    • "Mhat uni hospital" ood
  • Ruse, Bulgaria, 7002
    • Complex Oncology Center Rousse Eood
  • Sofia, Bulgaria, 13330
    • Medical Center Nadezhda Clinical EOOD
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda Umhat Ead, Department of Medical Oncology
• China
  • Beijing, China
    • Cancer Hospital Chinese Academy of Medical Sciences
  • Beijing, China
    • Beijing Cancer hosptial
  • Shandong, China, 276002
    • Linyi Cancer Hospital
  • Xiamen, China, 361005
    • The First Affiliated Hospital of Xiamen University - Oncology
  • Anhui
    • Hefei, Anhui, China, 230088
      • Anhui Provincial Cancer Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Southwest Hospital
    • Chongqing, Chongqing, China, 400030
      • Chongqing Cancer Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Gansu Provincial Hospital
  • Guangdong
    • Guanzhou, Guangdong, China, 510275
      • Sun yat-sen memorial hospital, sun yat-sen university (south)
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The Tumor Hospital Affiliated to Guangxi Medical University
  • Hainan
    • Haikou, Hainan, China, 570312
      • Hainan Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital - Oncology
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 400037
      • Hubei Cancer Hospital - Oncology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital - GCP Office
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221005
      • Xuzhou cancer hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University Branch Donghu
  • Jilin
    • Jilin, Jilin, China, 136100
      • Jilin Guowen Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110017
      • Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
  • Shanghai
    • Shanghai, Shanghai, China
      • Obstetrics and Gynecology Hospital of Fudan University
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Second Hospital of Shanxi Medical University
    • Xi'an, Shanxi, China, 710000
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Tianjin
    • Tianjin, Tianjin, China, 300070
      • Tianjin Medical University Cancer Institute & Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China, 830000
      • Affiliated Cancer Hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310003
      • The first Affiliated Hospital, Zhejiang University School of Medicine
• Korea, Republic of
  • Daegu, Korea, Republic of, 42601
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of
    • Kyemyung University Dongsan Hospital
  • Gyeonggi-do, Korea, Republic of
    • Ajou University Hospital
  • Gyeonggi-do, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Gyeonggi-do, Korea, Republic of
    • National Cancer Center
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of
    • Korea Institute of Radiological & Medical Sciences
• Poland
  • Gdynia, Poland
    • Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością
  • Konin, Poland, 62-500
    • Przychodnia Lekarska KOMED
• Russian Federation
  • Arkhangel'sk, Russian Federation
    • Arkhangelsk Regional Clinical Oncological Dispensary
  • Chelyabinsk, Russian Federation, 454087
    • State budgetary healthcare institution-chelyabinsk regional clinical center of oncology and nuclear
  • Krasnodar Krai
    • Krasnodar, Krasnodar Krai, Russian Federation, 350015
      • State healthcare institution oncologic dispensary no. 2 - health department of krasnodar region
  • Mordovia Republic
    • Saransk, Mordovia Republic, Russian Federation, 430005
      • Fsbi of higher education"ogarev mordovia state university"
  • Saint Petersburg
    • Pesochny, Saint Petersburg, Russian Federation, 197758
      • Oncological Scientific Center LLC
  • Stavropol Region
    • Pyatigorsk, Stavropol Region, Russian Federation
      • Sbhi of stavropol region "pyatigorsk interdistrict oncologic dispensary"
• Taiwan
  • Tainan, Taiwan
    • National Cheng Kung University Hospital
  • Tainan, Taiwan
    • Chi Mei Hospital, Liouying
  • Tainan, Taiwan
    • Linkou Chang Gung Memorial Hospital
  • Taipei, Taiwan
    • Mackay Memorial Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
• Thailand
  • Hat Yai, Thailand
    • Songklanagarind Hospital, Prince of Songkla University
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital (Khon Kaen University)
  • Ratchathewi, Thailand, 10400
    • Phramongkutklao Hospital
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Siriraj Hospital
• Ukraine
  • Kiev, Ukraine, 3022
    • National Cancer Institute
  • Kropyvnytskyi, Ukraine, 25006
    • Medical center of llc oncolife
  • Luts'k, Ukraine, 03322
    • Volyn Regional Medical Center Of Oncology
  • Ivano-Frankivsk
    • Ivano-Frankivsk Oblast, Ivano-Frankivsk, Ukraine, 00000
      • Public Non-Profit Institution "Precarpathian Oncology Center Of Ivano-Frankivsk Regional Council"
  • Kirovohradska Oblast
    • Kirovograd, Kirovohradska Oblast, Ukraine, 25006
      • Medical and diagnostic center of private enterprise private production company "acinus"
  • Sumska Oblast
    • Sumy, Sumska Oblast, Ukraine, 40022
      • Communal Non-Profit Enterprise Of Sumy Regional Council Sumy Regional Clinical Oncological Dispensar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

1. 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.
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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Ociperlimab + Tislelizumab; Tislelizumab 200 milligrams (mg) intravenously (IV) once every 3 weeks (Q3W) combined with ociperlimab (BGB-A1217) 900 mg IV Q3W	Biological: Tislelizumab; 200 mg administered intravenously once every 3 weeks on day 1 of each cycle; Other Names: BGB-A317; TEVIMBRA®; Biological: Ociperlimab; 900 mg administered intravenously once every 3 weeks on day 1 of each cycle; Other Names: BGB-A1217
Experimental: Cohort 2: Tislelizumab; Tislelizumab 200 mg IV Q3W monotherapy	Biological: Tislelizumab; 200 mg administered intravenously once every 3 weeks on day 1 of each cycle; Other Names: BGB-A317; TEVIMBRA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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: 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).	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).

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Study Director, BeiGene

Publications and helpful links

General 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

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): June 16, 2022
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Tislelizumab
• Other Study ID Numbers: BGB-A317-A1217-202; 2020-004657-77 (EudraCT Number); AdvanTIG-202 (Other Identifier: BeiGene); CTR20212809 (Other Identifier: ChinaDrugTrials); CTR20210588 (Other Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No