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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: Tislelizumab
* Drug: Ociperlimab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tislelizumab and Ociperlimab (BGB-A1217) Combination (Cohort 1)<br>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<br>* Administered as specified in the treatment arm<br>Drug: Ociperlimab<br>* Administered as specified in the treatment arm<br>* Other names: BGB-A1217;|
| Other: Tislelizumab Monotherapy (Cohort 2)<br>Tislelizumab 200 mg will be administered on Day 1 of each 21-day cycle | Drug: Tislelizumab<br>* Administered as specified in the treatment arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) assessed by Independent Review Committee (IRC) per RECIST v1.1 for Cohort 1 |  | approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Objective Response Rate (ORR) assessed by both IRC and investigator's review per RECIST v1.1 for Cohort 2 |  | approximately 3 years | 
| Duration of Response (DOR) assessed by both IRC and investigator's review |  | 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 | 
| 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 | 
| 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 | 
| Health-related quality of life (HRQoL) | Assessment of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | 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 | 
| Health-related quality of life (HRQoL) | Assessment of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module (EORTC QLQ-CX24) | approximately 3 years |