This is a Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study to evaluate the efficacy of WX390 in combination with toripalimab versus investigator's choice of therapy in patients with recurrent or metastatic cervical cancer who have failed at least one prior platinum-based systemic therapy, as assessed by overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
440
Participants will receive WX390 continuous oral dosing (1.1 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).
Randomization for these two strata will be closed upon reaching the total enrollment of 310 subjects who are immunotherapy-naïve or have tumors with PIK3CA wild-type status confirmed by the central laboratory.
Overall survival in cervical cancer patients who have failed at least one prior line of platinum-based therapy
Time frame: through study completion, an average of 3 years
Efficacy including ORR was assessed by both the investigator and a Blinded Independent Central Review committee according to RECIST v1.1 criteria.
Time frame: through study completion, an average of 1 year
Adverse Events (AEs), including type, incidence, grading (assessed according to the NCI-CTCAE v5.0 criteria), severity, and relationship to the investigational drug, among others.
Time frame: through study completion, an average of 3 years
Efficacy including DCR was assessed by both the investigator and a Blinded Independent Central Review committee according to RECIST v1.1 criteria.
Time frame: through study completion, an average of 1 year
Efficacy including DoR was assessed by both the investigator and a Blinded Independent Central Review committee according to RECIST v1.1 criteria.
Time frame: through study completion, an average of 1 year
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