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Clinical Trials List

Protocol NumberBGB-A317-A1217-202
NCT Number(ClinicalTrials.gov Identfier)NCT04693234
Completed

2020-12-01 - 2024-01-30

Phase II

Recruiting6

ICD-10C53.9

Malignant neoplasm of cervix uteri, unspecified

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9180.9

Malignant neoplasm of cervix uteri, unspecified

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

  • Trial Applicant

  • Sponsor

    BeiGene

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 張志隆 Division of Obstetrics & Gynecology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蕭聖諺 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Peng-Hui Wang Division of Obstetrics & Gynecology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Fang Cheng Division of Obstetrics & Gynecology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Yang Chou Division of Obstetrics & Gynecology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Huei-Jean Huang Division of Obstetrics & Gynecology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Recurrent or Metastatic Cervical Cancer

Objectives

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.

Test Drug

BGB-A317 、BGB-A1217

Active Ingredient

BGB-A317 、BGB-A1217

Dosage Form

concentrate for solution for infusion
concentrate for solution for infusion

Dosage

10 mg/ml
20 mg/ml

Endpoints

Primary Outcome Measures :
Objective Response Rate (ORR) assessed by Independent Review Committee (IRC) per RECIST v1.1 for Cohort 1 [ Time Frame: approximately 3 years ]

Inclution Criteria

Inclusion Criteria:

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.

Exclusion Criteria

Exclusion Criteria:

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.

The Estimated Number of Participants

  • Taiwan

    35 participants

  • Global

    238 participants

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