This study will compare the efficacy of 9MW2821+toripalimab versus 9MW2821 monotherapy in locally advanced or metastatic urothelial carcinoma patients who have not received any systemic treatment in the metastatic or advanced setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
a nectin-4 ADC with MMAE payload
anit-PD-1 antibody
Hunan Tumor Hospital
Changsha, Hunan, China
RECRUITINGNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGObjective Response Rate
Objective Response Rate based on BICR
Time frame: 3 yeras
Other efficacy endpoints
Overall survival; progression-free survival, duration of response, disease control rate, objective response rate based on investigator assessment and BICR
Time frame: 3 years
Safety assessment
Incidences, severity and rates of treatment-emergent adverse events and treatment-related adverse events as assessed by CTCAE v5.0. Incidence and rates serious adverse events. Frequency of clinically significant abnormalities in physical examination, safety laboratory tests, urinalysis, vital signs, and 12-Lead ECG record.
Time frame: 3 years
Immunogenicity
Incidence, rates of ADA and NAb development. Titer of ADA and NAb.
Time frame: 3 years
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