Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer
The clinical trial, identified as NCT06459687, is designed as a Phase III, interventional study focusing on the treatment of cervical cancer, specifically uterine cervical neoplasms. It is not yet recruiting and is expected to start on September 1, 2024, with a completion date of September 1, 2028. The study is sponsored by Lee's Pharmaceutical Limited.
Participants will be randomly assigned to one of two groups: one receiving Socazolimab combined with chemotherapy (cisplatin/carboplatin + paclitaxel) with or without bevacizumab, and the other receiving a placebo combined with the same chemotherapy regimen with or without bevacizumab. The treatment involves 6 to 8 cycles of the assigned intervention, followed by maintenance treatment with Socazolimab or placebo every three weeks.
Eligibility criteria include being female, aged between 18 and 75 years, with a life expectancy of at least 3 months, and having histologically confirmed cervical cancer that cannot be cured by surgery or radiotherapy. Participants must also have at least one measurable tumor lesion and provide tumor tissue samples. Exclusion criteria include prior anti-angiogenic therapy, active autoimmune disease, other active malignant tumors within the last 3 years, and various other medical conditions that could interfere with the study.
The primary goal of this study is to assess whether Socazolimab combined with chemotherapy with or without bevacizumab provides a better benefit to patients with persistent, recurrent, or metastatic cervical cancer as a first-line treatment compared to the placebo group. The study also aims to evaluate the safety profile of the treatment regimen.