Clinical trial NCT04693234: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2021-01-05
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cohort 1: Objective Response Rate (ORR) Assessed by an Independent Review Committee (IRC) in PD-L1-Positive Participants
timeFrame: 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.
measure: Cohort 1: ORR Assessed by the IRC in All Treated Participants
timeFrame: 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:
measure: Cohort 2: Objective Response Rate (ORR) Assessed by an Independent Review Committee in All Treated Participants
timeFrame: 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.
measure: ORR Assessed by the Investigator in PD-L1-Positive Participants
timeFrame: 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.
measure: ORR as Assessed by the Investigator in All Treated Participants
timeFrame: 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.
measure: Duration of Response (DOR) Assessed by the IRC
timeFrame: 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.
measure: Duration of Response (DOR) Assessed by the Investigator
timeFrame: 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.
measure: Progression Free Survival (PFS)
timeFrame: 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.
measure: Time to Response (TTR) Assessed by the IRC
timeFrame: 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.
measure: Time to Response (TTR) Assessed by the Investigator
timeFrame: 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.
measure: Disease Control Rate (DCR)
timeFrame: 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.
measure: Clinical Benefit Rate (CBR)
timeFrame: 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.
measure: Overall Survival (OS)
timeFrame: 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.
measure: 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
timeFrame: Baseline to Cycles 3 and 5 ( Each cycle was 21 days)
measure: 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
timeFrame: Baseline to Cycles 3 and 5 ( Each cycle was 21 days)
measure: Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From the first dose of study drug to 30 days after the last dose; maximum treatment exposure was 23.5 months.
measure: Serum Ociperlimab (BGB-A1217) Concentrations at Specified Timepoints
timeFrame: Day 1 of Cycles 1, 2, 5, 9, and 17 (each cycle was 21 days)
measure: Serum Tislelizumab Concentrations at Specified Timepoints
timeFrame: Day 1 of Cycles 1, 2, 5, 9, and 17 (each cycle is 21 days)
measure: Number of Participants Who Developed Positive Anti-drug Antibodies (ADAs) to Ociperlimab
timeFrame: 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).
measure: Number of Participants Who Developed Anti-drug Antibodies (ADAs) to Tislelizumab
timeFrame: 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).
Other outcomes:
Locations:
city: Panagyurishte
country: Bulgaria
facility: "Mhat uni hospital" ood
city: Ruse
country: Bulgaria
facility: Complex Oncology Center Rousse Eood
city: Sofia
country: Bulgaria
facility: Medical center nadezhda clinical eood
city: Sofia
country: Bulgaria
facility: Acibadem city clinic tokuda umhat ead, department of medical oncology
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
city: Lanzhou
country: China
facility: Gansu Provincial Hospital
state: Gansu
city: Guanzhou
country: China
facility: Sun yat-sen memorial hospital, sun yat-sen university (south)
state: Guangdong
city: Nanning
country: China
facility: The Tumor Hospital Affiliated to Guangxi Medical University
state: Guangxi
city: Haikou
country: China
facility: Hainan Cancer Hospital
state: Hainan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital - Oncology
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital - Oncology
state: Hubei
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital - GCP Office
state: Hunan
city: Xuzhou
country: China
facility: Xuzhou Cancer Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University Branch Donghu
state: Jiangxi
city: Jilin
country: China
facility: Jilin Guowen Hospital
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: Second Hospital Of Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University Cancer institute & Hospital
state: Tianjin
city: Urumqi
country: China
facility: Affiliated Cancer Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Cancer Hosptial
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Shandong
country: China
facility: Linyi Cancer Hospital
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University - Oncology
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyemyung University Dongsan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Institute of Radiological & Medical Sciences
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością
city: Konin
country: Poland
facility: Przychodnia lekarska komed
city: Krasnodar
country: Russian Federation
facility: State healthcare institution oncologic dispensary no. 2 - health department of krasnodar region
state: Krasnodar Krai
city: Saransk
country: Russian Federation
facility: Fsbi of higher education"ogarev mordovia state university"
state: Mordovia Republic
city: Pesochny
country: Russian Federation
facility: Oncological Scientific Center LLC
state: Saint Petersburg
city: Pyatigorsk
country: Russian Federation
facility: Sbhi of stavropol region "pyatigorsk interdistrict oncologic dispensary"
state: Stavropol Region
city: Arkhangel'sk
country: Russian Federation
facility: Arkhangelsk regional clinical oncological dispensary
city: Chelyabinsk
country: Russian Federation
facility: State budgetary healthcare institution-chelyabinsk regional clinical center of oncology and nuclear
city: Tainan
country: Taiwan
facility: Chi Mei Hospital, Liouying
city: Tainan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital, Prince of Songkla University
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital (Khon Kaen University)
city: Ratchathewi
country: Thailand
facility: Phramongkutklao Hospital
city: Ivano-Frankivsk Oblast
country: Ukraine
facility: Public Non-Profit Institution "Precarpathian Oncology Center Of Ivano-Frankivsk Regional Council"
state: Ivano-Frankivsk
city: Kirovograd
country: Ukraine
facility: Medical and diagnostic center of private enterprise private production company "acinus"
state: Kirovohradska Oblast
city: Sumy
country: Ukraine
facility: Communal Non-Profit Enterprise Of Sumy Regional Council Sumy Regional Clinical Oncological Dispensar
state: Sumska Oblast
city: Kiev
country: Ukraine
facility: National Cancer Institute
city: Kropyvnytskyi
country: Ukraine
facility: Medical center of llc oncolife
city: Luts'k
country: Ukraine
facility: Volyn Regional Medical Center Of Oncology
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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 May 23;198:25-32. doi: 10.1016/j.ygyno.2025.04.579. Online ahead of print.