NCT06459687

Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer

Efficacy and Safety of Socazolimab Combined With Chemotherapy With or Without Bevacizumab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer: A Randomized, Double-blind, Placebo-controlled Phase III Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab	6\~8 cycles of Socazolimab (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w. Followed with Socazolimab (5 mg/kg), Q3w.
DRUG	Placebo+cisplatin/carboplatin+paclitaxel+Bevacizumab	6\~8 cycles of placebo (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w. Followed with placebo (5 mg/kg), Q3w.

Timeline

• Start date: 2024-11-28
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2024-06-14
• Last updated: 2025-05-14

Locations

5 sites across 1 country: China