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ENROLLING BY INVITATION
NCT06755515
PHASE2/PHASE3

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

Sponsor: Shandong New Time Pharmaceutical Co., LTD

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

510

Start Date

2024-09-26

Completion Date

2028-09

Last Updated

2025-01-01

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Shandong New Time Pharmaceutical Co., LTD

Linyi, Shandong, China