Phase 2
Completed N=178
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
Source: ClinicalTrials.gov NCT04693234 ↗Enrolled (actual)
178
Serious AEs
43.8%
Results posted
Apr 2025
Primary outcomePrimary: Cohort 1: Objective Response Rate (ORR) Assessed by an Independent Review Committee (IRC) in PD-L1-Positive Participants — 26.2 percentage of participants — p=0.0054
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1: Objective Response Rate (ORR) Assessed by an Independent Review Committee (IRC) in PD-L1-Positive Participants |
26.2 | 0.0054 sig |
| PRIMARY Cohort 1: ORR Assessed by the IRC in All Treated Participants |
22.5 | 0.0127 sig |
| SECONDARY Cohort 2: Objective Response Rate (ORR) Assessed by an Independent Review Committee in All Treated Participants |
32.5 | — |
| SECONDARY ORR Assessed by the Investigator in PD-L1-Positive Participants |
25.0; 30 | — |
| SECONDARY ORR as Assessed by the Investigator in All Treated Participants |
21.0; 22.5 | — |
| SECONDARY Duration of Response (DOR) Assessed by the IRC |
NA; NA | — |
| SECONDARY Duration of Response (DOR) Assessed by the Investigator |
NA; NA | — |
| SECONDARY Progression Free Survival (PFS) |
3.5; 5.7; 3.9; 5.7 | — |
| SECONDARY Time to Response (TTR) Assessed by the IRC |
9.02; 11.78 | — |
| SECONDARY Time to Response (TTR) Assessed by the Investigator |
10.66; 8.92 | — |
| SECONDARY Disease Control Rate (DCR) |
63.0; 67.5; 62.3; 75.0 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
29.0; 50.0; 31.2; 50.0 | — |
| SECONDARY Overall Survival (OS) |
9.0; NA | — |
| SECONDARY 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 |
64.21; 62.06; 0.37; 5.30; 3.46; 5.13 | — |
| SECONDARY 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 |
30.86; 31.43; 0.61; -0.71; -0.15; 1.05 | — |
| SECONDARY Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
135; 39; 61; 17 | — |
| SECONDARY Serum Ociperlimab (BGB-A1217) Concentrations at Specified Timepoints |
0.00; 363.19; 46.60; 82.57; 440.70; 89.13 | — |
| SECONDARY Serum Tislelizumab Concentrations at Specified Timepoints |
0.00; 77.38; 0.00; 84.24; 17.86; 20.03 | — |
| SECONDARY Number of Participants Who Developed Positive Anti-drug Antibodies (ADAs) to Ociperlimab |
— | — |
| SECONDARY Number of Participants Who Developed Anti-drug Antibodies (ADAs) to Tislelizumab |
19; 7 | — |
Eligibility 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
- 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT04693234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.