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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
498
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGLiaoning Cancer Hospital
Shenyang, Liaoning, China
RECRUITINGPFS by BICR based on RECIST v1.1
PFS by BICR based on RECIST v1.1
Time frame: Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months)
OS
OS
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years
PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria
PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria
Time frame: Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months
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Intravenous Infusion