NCT05798819

A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate GLS-010 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (estimated)
• Sponsor: Guangzhou Gloria Biosciences Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled phase III study to evaluate GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.

Detailed description

This is a randomized, double-blind, placebo-controlled phase III study，aimed to evaluate the efficacy and safety of GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.

Conditions

• Persistent, Recurrent, or Metastatic Cervical Cancer

Interventions

Type	Name	Description
DRUG	GLS-010	IV infusion
DRUG	Placebo	IV infusion
DRUG	paclitaxel	IV infusion
DRUG	cisplatin	IV infusion
DRUG	carboplatin	IV infusion
DRUG	bevacizumab	IV infusion

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-05-01
• Completion: 2026-12-01
• First posted: 2023-04-05
• Last updated: 2023-04-05

Locations

1 site across 1 country: China