At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-blind, Placebo-controlled, Multicentre Phase Ш Clinical Study to Evaluate the Efficacy and Safety of First-line Treatment With SG001 Plus Chemotherapy±Bevacizumab Versus Placebo Plus Chemotherapy±Bevacizumab for PD-L1 Positive (CPS≥1) Women With Recurrent, or Metastatic Cervical Cancer
In Brief
A Phase 3 clinical trial evaluating SG001 injection, Paclitaxel, and 4 other interventions for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1). Not yet recruiting, targeting 368 participants.
Detailed Summary
This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy±bevacizumab versus placebo plus chemotherapy±bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS≥1), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001＋Chemotherapy±Bevacizumab will be assessed prior to the Phase 3 portion of the study.
Study Details
Timeline
Interventions
360 mg，Q3W，IV infusion
175 mg/m\^2，Q3W，IV infusion
50 mg/m\^2，Q3W，IV infusion
AUC=5，Q3W，IV infusion
15 mg/kg，Q3W，IV infusion
Q3W，IV infusion