The purpose of this study was to compare the antitumor activity of 9MW2821 and chemotherapy in participants with locally advanced or metastatic urothelial cancer previously treated with PD-(L)1 inhibitor and platinum-containing chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
432
1.25mg/kg of 9MW2821 by intravenous infusion on days 1, 8 and 15 of every 28-day cycle
75mg/m\^2 docetaxel by intravenous infusion or 175 mg/m\^2 paclitaxel by intravenous infusion on day 1 of every 21-day cycle.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGProgression Free Survival per Blinded Independent Central Review
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
Overall 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 Blinded Independent Central Review and investigator
The percentage of subjects who experience a best response of either CR or PR
Time frame: Up to 3 years
Duration of Response per Blinded Independent Central Review and 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 Blinded Independent Central Review and investigator
Time from the date of randomization to the date of confirmed CR or PR
Time frame: Up to 3 years
Disease Control Rate per Blinded Independent Central Review and investigator
Defined as 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
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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
Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality-of-life questionnaire (QLQ-C30)
Time frame: Up to 3 years
Mean change from baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)
Time frame: Up to 3 years