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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04693234 |
Recruitment Status :
Active, not recruiting
First Posted : January 5, 2021
Last Update Posted : July 28, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Cancer | Drug: Tislelizumab Drug: Ociperlimab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 167 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 15, 2021 |
Actual Primary Completion Date : | June 16, 2022 |
Estimated Study Completion Date : | March 31, 2023 |

Arm | Intervention/treatment |
---|---|
Tislelizumab and Ociperlimab (BGB-A1217) Combination (Cohort 1)
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.
|
Drug: Tislelizumab
Administered as specified in the treatment arm Drug: Ociperlimab Administered as specified in the treatment arm
Other Name: BGB-A1217 |
Tislelizumab Monotherapy (Cohort 2)
Tislelizumab 200 mg will be administered on Day 1 of each 21-day cycle
|
Drug: Tislelizumab
Administered as specified in the treatment arm |
- Objective Response Rate (ORR) assessed by Independent Review Committee (IRC) per RECIST v1.1 for Cohort 1 [ Time Frame: 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 [ Time Frame: approximately 3 years ]
- Objective Response Rate (ORR) assessed by both IRC and investigator's review per RECIST v1.1 for Cohort 2 [ Time Frame: approximately 3 years ]
- Duration of Response (DOR) assessed by both IRC and investigator's review [ Time Frame: approximately 3 years ]
- Progression Free Survival (PFS) assessed by both IRC and investigator's review [ Time Frame: Date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first, approximately 3 years ]
- Time to Response (TTR) assessed by both IRC and investigator's review [ Time Frame: date of first dose of study drug to first documentation of response, approximately 3 years ]
- Disease Control Rate (DCR) assessed by both IRC and investigator's review [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Date of first dose of study drug until the date of death from any cause for Cohorts 1 and 2, approximately 3 years ]
- Health-related quality of life (HRQoL) [ Time Frame: approximately 3 years ]Assessment of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
- 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 [ Time Frame: approximately 3 years ]
- Serum BGB-A1217 and tislelizumab concentrations at specified timepoints [ Time Frame: 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) [ Time Frame: date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first, approximately 3 years ]
- Health-related quality of life (HRQoL) [ Time Frame: approximately 3 years ]Assessment of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module (EORTC QLQ-CX24)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
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:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693234

Study Director: | Xiyan Mu | BeiGene |
Responsible Party: | BeiGene |
ClinicalTrials.gov Identifier: | NCT04693234 |
Other Study ID Numbers: |
BGB-A317-A1217-202 2020-004657-77 ( EudraCT Number ) AdvanTIG-202 ( Other Identifier: BeiGene ) |
First Posted: | January 5, 2021 Key Record Dates |
Last Update Posted: | July 28, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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 |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |