A Phase 3 interventional study of QL1706 and Placebo in METASTATIC CERVICAL CANCER, sponsored by Qilu Pharmaceutical Co., Ltd.. Recruiting at 3 sites in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-30.
Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
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
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 498 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
QL1706 (5 mg/kg) + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)
Drug: QL1706 · Drug: Paclitaxel injection · Drug: Cisplatin/Carboplatin
Placebo + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)
Drug: Placebo · Drug: Paclitaxel injection · Drug: Cisplatin/Carboplatin
Intravenous Infusion
Intravenous Infusion
Intravenous Infusion
Intravenous Infusion
PFS 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
Plan to share: No — Involves subject privacy and does not intend to share
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Qilu Pharmaceutical Co., Ltd.