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NOT YET RECRUITING
NCT05715840
PHASE3

Efficacy and Safety Study of First-line Treatment With SG001 Plus Chemotherapy ± Bevacizumab Versus Placebo Plus Chemotherapy ±Bevacizumab for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)

Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

368

Start Date

2023-01-31

Completion Date

2026-05-31

Last Updated

2023-02-08

Healthy Volunteers

No

Interventions

DRUG

SG001 injection

360 mg,Q3W,IV infusion

DRUG

Paclitaxel

175 mg/m\^2,Q3W,IV infusion

DRUG

Cisplatin

50 mg/m\^2,Q3W,IV infusion

DRUG

Carboplatin

AUC=5,Q3W,IV infusion

DRUG

Bevacizumab injection

15 mg/kg,Q3W,IV infusion

DRUG

SG001 placebo

Q3W,IV infusion