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QL1706 Plus Chemotherapy±Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer

METASTATIC CERVICAL CANCER Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate QL1706 Plus Paclitaxel-Cisplatin/Carboplatin With or Without Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer

Clinical Trial Summary

This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study in 498 patients with persistent, recurrent or metastatic cervical cancer.Experimental: QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab; Control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab

Clinical Trial Description

Subjects must provide sufficient archival or newly obtained tumor tissue samples to determine PD-L1 expression level to be eligible for screening.During the screening phase, eligible subjects will be stratified by use of bevacizumab (yes vs no), prior concurrent chemoradiation therapy (yes vs no), and PD- L1 level (CPS < 1 vs 1 ≤ CPS < 10 vs CPS ≥ 10) and randomized 1:1 into the experimental or control arm.Experimental: QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab;Control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05446883
Study type Interventional
Source Qilu Pharmaceutical Co., Ltd.
Contact Xiaoli Zhang
Phone 008610-50813552
Email xiaoli3.zhang@qilu-pharma.com
Status Recruiting
Phase Phase 3
Start date September 23, 2022
Completion date July 1, 2025
View Details
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