drugset / Trial / NCT06459687
Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. The main question it aims to answer is: Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent, recurrent, or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab. Participants will be treated with Socazolimab/placebo + chemotherapy ± bevacizumab) for 6\~8 cycles (Q3w), following maintenance treatment of Socazolimab/placebo (Q3w).
Timeline
- Start
- 2024-11-28
- Primary completion
- 2027-09-01
- Completion
- 2028-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Socazolimab | Monoclonal antibody | 5 mg/kg | — |
| Background | Bevacizumab | Monoclonal antibody | 15 mg/kg | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | 50 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | — |