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.
Signed the informed consent form.
Women aged ≥ 18 and ≤ 75 years.
ECOG of 0 or 1.
Life expectancy ≥ 12 weeks.
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.
Parallel
GLS-010
DrugIV infusion
Placebo
DrugIV infusion
paclitaxel
DrugIV infusion
cisplatin
DrugIV infusion
carboplatin
DrugIV infusion
bevacizumab
DrugIV infusion
overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
progression-free survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1.
Objective Response Rate (ORR)
Proportion of subjects who have a complete or partial response relative to baseline based on RECIST 1.1 criteria.
Duration of Response (DOR)
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
Disease Control Rate (DCR)
DCR defined as the proportion of subjects' response of CR, PR, or SD based on RECIST v1.1 criteria.
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