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)

Conditions

• Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• SG001 injection — DRUG
  360 mg，Q3W，IV infusion
• Paclitaxel — DRUG
  175 mg/m\^2，Q3W，IV infusion
• Cisplatin — DRUG
  50 mg/m\^2，Q3W，IV infusion
• Carboplatin — DRUG
  AUC=5，Q3W，IV infusion
• Bevacizumab injection — DRUG
  15 mg/kg，Q3W，IV infusion
• SG001 placebo — DRUG
  Q3W，IV infusion

Study Details

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.

Key Dates

First listed

Feb 8, 2023

Start date

Jan 31, 2023

Status verified

Jan 2023

Primary completion

Jul 31, 2024

Completion

May 31, 2026

Study Design

Enrollment

368 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab
  SG001 360 mg, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m\^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m\^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity
• Placebo Comparator: Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab
  Placebo, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m\^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m\^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity

Primary Outcome Measure

Safety Lead-in [ Time Frame: Up to 42 days after the last patient of the lead-in phase ]

Central Contacts

• Fenglin She, MSc
  010-63942533
  [email protected]