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

Completed

• Conditions: Cervical Cancer
• Interventions: Drug: Tislelizumab; Drug: Ociperlimab

• Registration Number: NCT04693234
• Lead Sponsor: BeiGene

Brief Summary

This is an open-label, 2-cohort, multicenter, Phase 2 study to evaluate the efficacy and safety of tislelizumab combined with or without ociperlimab (BGB-A1217) in participants with previously treated recurrent or metastatic cervical cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Study Start: 2021-02-15
• Primary Completion: 2022-06-16
• Study Completion: 2023-08-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 178

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tislelizumab Monotherapy (Cohort 2)	Tislelizumab	Tislelizumab 200 mg will be administered on Day 1 of each 21-day cycle
Tislelizumab and Ociperlimab (BGB-A1217) Combination (Cohort 1)	Tislelizumab	Participants will receive tislelizumab 200 milligrams (mg) on Day 1 followed by the administration of ociperlimab (BGB-A1217) 900 mg of each 21-day cycle.
Tislelizumab and Ociperlimab (BGB-A1217) Combination (Cohort 1)	Ociperlimab	Participants will receive tislelizumab 200 milligrams (mg) on Day 1 followed by the administration of ociperlimab (BGB-A1217) 900 mg of each 21-day cycle.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) assessed by Independent Review Committee (IRC) per RECIST v1.1 for Cohort 1	approximately 3 years

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR) assessed by both IRC and investigator's review	approximately 3 years
Time to Response (TTR) assessed by both IRC and investigator's review	date of first dose of study drug to first documentation of response, approximately 3 years
Health-related quality of life (HRQoL)	approximately 3 years	Assessment of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module (EORTC QLQ-CX24)
Objective Response Rate (ORR) assessed by both IRC and investigator's review per RECIST v1.1 for Cohort 2	approximately 3 years
Progression Free Survival (PFS) assessed by both IRC and investigator's review	Date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first, approximately 3 years
Objective Response Rate (ORR) assessed by investigator's review per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 for Cohort 1	approximately 3 years
Disease Control Rate (DCR) assessed by both IRC and investigator's review	the proportion of patients who achieve CR, PR, or stable disease (SD) approximately 3 years
Clinical Benefit Rate (CBR) assessed by both IRC and investigator's review	the proportion of patients who achieve CR, PR, or durable SD (SD ≥ 24 weeks), approximately 3 years
Overall Survival (OS) assessed by both IRC and investigator's review	Date of first dose of study drug until the date of death from any cause for Cohorts 1 and 2, approximately 3 years
Adverse events (AEs) and serious adverse events (SAEs) as assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0 for Cohorts 1 and 2	approximately 3 years
Serum BGB-A1217 and tislelizumab concentrations at specified timepoints	specified timepoints up to 30 (±7) days after last dose, approximately 3 years
Immunogenic responses to BGB-A1217 and tislelizumab, evaluated through the detection of antidrug antibodies (ADAs)	date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first, approximately 3 years

Trial Locations

Locations (31)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan

Medical center nadezhda clinical eood; 🇧🇬 Sofia, Bulgaria

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

State budgetary healthcare institution-chelyabinsk regional clinical center of oncology and nuclear; 🇷🇺 Chelyabinsk, Russian Federation

Siriraj Hospital; 🇹🇭 Bangkok Noi, Bangkok, Thailand

Linkou Chang Gung Memorial Hospital; 🇨🇳 Tainan, Taiwan

Medical and diagnostic center of private enterprise private production company "acinus"; 🇺🇦 Kirovograd, Kirovohradska Oblast, Ukraine

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Chi Mei Hospital, Liouying; 🇨🇳 Tainan, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Sbhi of stavropol region "pyatigorsk interdistrict oncologic dispensary"; 🇷🇺 Pyatigorsk, Stavropol Region, Russian Federation

Arkhangelsk regional clinical oncological dispensary; 🇷🇺 Arkhangel'sk, Russian Federation

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

National Cancer Center; 🇰🇷 Gyeonggi-do, Korea, Republic of

Sun yat-sen memorial hospital, sun yat-sen university (south); 🇨🇳 Guanzhou, Guangdong, China

Acibadem city clinic tokuda umhat ead, department of medical oncology; 🇧🇬 Sofia, Bulgaria

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China

Kyemyung University Dongsan Hospital; 🇰🇷 Daegu, Korea, Republic of

"Mhat uni hospital" ood; 🇧🇬 Panagyurishte, Bulgaria

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Ajou University Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Przychodnia lekarska komed; 🇵🇱 Konin, Poland

Korea Institute of Radiological & Medical Sciences; 🇰🇷 Seoul, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Fsbi of higher education"ogarev mordovia state university"; 🇷🇺 Saransk, Mordovia Republic, Russian Federation

State healthcare institution oncologic dispensary no. 2 - health department of krasnodar region; 🇷🇺 Krasnodar, Krasnodar Krai, Russian Federation

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Medical center of llc oncolife; 🇺🇦 Kropyvnytskyi, Ukraine