NCT06755515

A Phase Ⅱ/Ⅲ Study of Rulonilimab Plus Chemotherapy± Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer

A Phase Ⅱ/Ⅲ Randomized, Double-Blind, Placebo-Controlled Trial of Rulonilimab Plus Chemotherapy± Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 510 (estimated)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was an randomized, double-Blind, placebo-controlled, multicenter Phase II/III study.

Detailed description

The trial was divided into screening period, treatment period and follow-up period. Participants entered the screening period after signing informed consent and met the inclusion criteria. Subjects who did not meet the exclusion criteria were treated with Rulonilimab/placebo plus chemotherapy ± bevacizumab, intravenously, at target dose every 3 weeks until disease progression or intolerable toxicity or withdrawal for other reasons, for a maximum of 2 years.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Rulonilimab	Drug: Rulonilimab Description: iv, 200mg every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons. Drug: Bevacizumab Description: iv, 15mg/kg every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons. Drug: Cisplatin Description: iv, 50mg/m\^2 every 3 weeks, for up to 6 cycles. Drug: Carboplatin Description: iv, AUC 4\~6 every 3 weeks, for up to 6 cycles. Drug: Paclitaxel Description: iv, 175mg/m\^2 every 3 weeks, for up to 6 cycles.
DRUG	Placebo	Drug: placebo Description: iv, every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons. Drug: Bevacizumab Description: iv, 15mg/kg every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons. Drug: Cisplatin Description: iv, 50mg/m\^2 every 3 weeks, for up to 6 cycles. Drug: Carboplatin Description: iv, AUC 4\~6 every 3 weeks, for up to 6 cycles. Drug: Paclitaxel Description: iv, 175mg/m\^2 every 3 weeks, for up to 6 cycles.
DRUG	cisplatin/carboplatin + paclitaxel ± bevacizumab	cisplatin/carboplatin + paclitaxel ± bevacizumab

Timeline

• Start date: 2024-09-26
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-01-01
• Last updated: 2025-01-01

Locations

1 site across 1 country: China