The purpose of this study is to compare the efficacy and safety of 9MW2821 and chemotherapy in participants with recurrent or metastatic cervical cancer who progressed on or after platinum-based chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
1.25mg/kg of 9MW2821 by intravenous infusion on days 1, 8 and 15 of every 28-day cycle
1.0 or 1.25 mg/m \^2 topotecan by intravenous infusion on days 1 to 5 or 1000 mg/m \^2 gemcitabine by intravenous infusion on days 1 and 8 or 500 mg/m \^2 pemetrexed by intravenous infusion on day 1 of every 21 days
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGOverall Survival
Time from the date of randomization until the date of death from any cause.
Time frame: Up to 3 years
Objective Response Rate per investigator
The percentage of subjects who experience a best response of either CR or PR.
Time frame: Up to 3 years
Disease Control Rate per investigator
The percentage of subjects who experience a best response of CR, PR or stable disease (SD).
Time frame: Up to 3 years
Progression Free Survival per investigator
Time from the date of first randomization to the earliest date of documented disease progression per radiological evidence or death from any cause.
Time frame: Up to 3 years
Duration of Response per investigator
Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause.
Time frame: Up to 3 years
Time to response per investigator
Time from the date of randomization to the date of CR or PR.
Time frame: Up to 3 years
Incidence of adverse events
Time frame: Up to 3 years
Incidence of Anti-Drug Antibody (ADA)
Time frame: Up to 3 years
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