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

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

Apr 20, 2023

Status verified

Sep 2026

Primary completion

Dec 31, 2029

Completion

Dec 1, 2030

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 ]