This is a single arm, open-label, multicenter phase II clinical study to evaluate the safety and efficacy of 9MW2821 combined with Toripalimab in perioperative patients with urothelial cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
9MW2821, 1.25mg/kg, intravenous (IV) infusion
Toripalimab, 240mg, intravenous (IV) infusion
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGpCR (Arm 1 and 2)
Pathological complete response
Time frame: Up to 24 months
cCR (Arm 3)
Clinical complete response
Time frame: Up to 24 months
cORR
Clinical objective response rate
Time frame: Up to 24 months
Pathological downstaging rate (Arm 1 and 2)
Time frame: Up to 24 months
DFS (Arm 1 and 2)
Disease-free survival
Time frame: Up to 24 months
Duration of clinical complete response (Arm 3)
Time frame: Up to 24 months
PFS (Arm 3)
Progression-free survival
Time frame: Up to 24 months
OS
Overall Survival
Time frame: Up to 24 months
AE/SAE
Adverse event, serious adverse event
Time frame: Up to 24 months
Immunogenicity
Anti-Drug Antibody (ADA) of 9MW2821
Time frame: Up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Nectin-4 and PD-L1 expression
Time frame: Up to 24 months