A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

Sponsor
Guangzhou Gloria Biosciences Co., Ltd.
Study ID
NCT05798819
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Persistent, Recurrent, or Metastatic Cervical Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • GLS-010 — DRUG
    IV infusion
  • Placebo — DRUG
    IV infusion
  • paclitaxel — DRUG
    IV infusion
  • cisplatin — DRUG
    IV infusion
  • carboplatin — DRUG
    IV infusion
  • bevacizumab — DRUG
    IV infusion

Study Details

This is a randomized, double-blind, placebo-controlled phase III study to evaluate GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.

Key Dates

First listed
Apr 5, 2023
Start date
May 1, 2023
Status verified
Apr 2023
Primary completion
May 1, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
424 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GLS-010+chemotherapy± bevacizumab
    GLS-010 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
  • Placebo Comparator: Placebo+chemotherapy± bevacizumab
    Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab

Primary Outcome Measure

overall survival (OS) [ Time Frame: Up to 2 years ]