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

NCT04693234 | Completed Phase 2 Results

• 5 other identifiers: BGB-A317-A1217-2022020-004657-77AdvanTIG-202CTR20212809CTR20210588
• Study Type: interventional
• Target: 178
• Locations: 8 countries
• Sites: 68

Brief 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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Cohort 2: Objective Response Rate (ORR) Assessed by an Independent Review Committee in All Treated 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.

• ORR Assessed by the Investigator in PD-L1-Positive 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.

• ORR as Assessed by the Investigator in All Treated 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.

• Duration of Response (DOR) Assessed by the IRC

  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

  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.

Study Arms (2)

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

Biological: Tislelizumab; Biological: Ociperlimab

Cohort 2: Tislelizumab

EXPERIMENTAL

Tislelizumab 200 mg IV Q3W monotherapy

Biological: Tislelizumab

Interventions

Tislelizumab BIOLOGICAL

200 mg administered intravenously once every 3 weeks on day 1 of each cycle

Also known as: BGB-A317, TEVIMBRA®

Cohort 1: Ociperlimab + Tislelizumab; Cohort 2: Tislelizumab

Ociperlimab BIOLOGICAL

900 mg administered intravenously once every 3 weeks on day 1 of each cycle

Also known as: BGB-A1217

Cohort 1: Ociperlimab + Tislelizumab

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (68)

"Mhat uni hospital" ood

Panagyurishte, 4500, Bulgaria

Location

Complex Oncology Center Rousse Eood

Rousse, 7002, Bulgaria

Location

Medical center nadezhda clinical eood

Sofia, 13330, Bulgaria

Location

Acibadem city clinic tokuda umhat ead, department of medical oncology

Sofia, 1407, Bulgaria

Location

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230088, China

Location

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

Location

Gansu Provincial Hospital

Lanzhou, Gansu, 730000, China

Location

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

Guanzhou, Guangdong, 510275, China

Location

The Tumor Hospital Affiliated to Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Hainan Cancer Hospital

Haikou, Hainan, 570312, China

Location

Henan Cancer Hospital - Oncology

Zhengzhou, Henan, 450008, China

Location

Hubei Cancer Hospital - Oncology

Wuhan, Hubei, 400037, China

Location

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

Wuhan, Hubei, 430022, China

Location

Hunan Cancer Hospital - GCP Office

Changsha, Hunan, 410013, China

Location

Xuzhou Cancer Hospital

Xuzhou, Jiangsu, 221005, China

Location

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, 330006, China

Location

Jilin Guowen Hospital

Jilin, Jilin, 136100, China

Location

Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology

Shenyang, Liaoning, 110017, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

Second Hospital Of Shanxi Medical University

Taiyuan, Shanxi, 030013, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710000, China

Location

Tianjin Medical University Cancer institute & Hospital

Tianjin, Tianjin Municipality, 300070, China

Location

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830000, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Beijing Cancer Hosptial

Beijing, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Location

Linyi Cancer Hospital

Shandong, 276002, China

Location

The First Affiliated Hospital of Xiamen University - Oncology

Xiamen, 361005, China

Location

Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością

Gdynia, Poland

Location

Przychodnia lekarska komed

Konin, 62-500, Poland

Location

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

Krasnodar, Krasnodarskiy Kray, 350015, Russia

Location

Fsbi of higher education"ogarev mordovia state university"

Saransk, Mordovia Republic, 430005, Russia

Location

Oncological Scientific Center LLC

Pesochny, Sankt-Peterburg, 197758, Russia

Location

Sbhi of stavropol region "pyatigorsk interdistrict oncologic dispensary"

Pyatigorsk, Stavropol Kray, Russia

Location

Arkhangelsk regional clinical oncological dispensary

Arkhangelsk, Russia

Location

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

Chelyabinsk, 454087, Russia

Location

Keimyung University Dongsan Medical Center

Daegu, 42601, South Korea

Location

Kyemyung University Dongsan Hospital

Daegu, South Korea

Location

Ajou University Hospital

Gyeonggi-do, South Korea

Location

National Cancer Center

Gyeonggi-do, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Korea Institute of Radiological & Medical Sciences

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

Chi Mei Hospital, Liouying

Tainan, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Tainan, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Songklanagarind Hospital, Prince of Songkla University

Hat Yai, Thailand

Location

Srinagarind Hospital (Khon Kaen University)

Khon Kaen, 40002, Thailand

Location

Phramongkutklao Hospital

Ratchathewi, 10400, Thailand

Location

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

Ivano-Frankivsk Oblast, Ivano-Frankivsk Oblast, 00000, Ukraine

Location

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

Kirovograd, Kirovohrad Oblast, 25006, Ukraine

Location

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

Sumy, Sumska Oblast, 40022, Ukraine

Location

National Cancer Institute

Kiev, 3022, Ukraine

Location

Medical center of llc oncolife

Kropyvnytskyi, 25006, Ukraine

Location

Volyn Regional Medical Center Of Oncology

Lutsk, 03322, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 40411966 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

+1-877-828-5568

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 5, 2021
• Study Start: February 15, 2021
• Primary Completion: June 16, 2022
• Study Completion: August 31, 2023
• Last Updated: April 27, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

RU (6); KR (12); UA (6); BU (4); CN (28); PL (2); TW (6); TH (4)