About this trial
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.
Eligibility criteria
Qualifiers
Signed the informed consent form.
Women aged ≥ 18 and ≤ 75 years.
ECOG of 0 or 1.
Life expectancy ≥ 12 weeks.
Disqualifiers
Patients with the opportunity to be cured by surgery and radiotherapy.
Received with concurrent chemoradiotherapy, adjuvant chemotherapy,neo- adjuvant chemotherapy within 4 weeks prior to randomization.
Active central nervous system (CNS) metastasis.
Patients with other malignancies prior to randomization. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast cancer) that have been cured are not excluded.
Trial design
Treatments tested in this trial
- GLS-010
- Placebo
- paclitaxel
- cisplatin
- carboplatin
- bevacizumab