This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN003 versus investigator's choice of chemotherapy in patients with platinum-resistant, relapsed epithelial Ovarian, primary peritoneal, or fallopian tube cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
430
Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1
PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
Time frame: Up to approximately 22 months
Overall Survival (OS)
OS was defined as the time from the date of first dose until the date of death from any cause
Time frame: Up to approximately 22 months
Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1
ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
Time frame: Up to approximately 22 months
Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1
DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first
Time frame: Up to approximately 22 months
Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1
DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)
Time frame: Up to approximately 22 months
PFS evaluated by the Investigator as per RECIST 1.1
PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
Time frame: Up to approximately 22 months
ORR evaluated by the Investigator as per RECIST 1.1
ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Active Comparator
Time frame: Up to approximately 22 months
DoR evaluated by the Investigator as per RECIST 1.1
DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first
Time frame: Up to approximately 22 months
DCR evaluated by the Investigator as per RECIST 1.1
DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)
Time frame: Up to approximately 22 months
CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria
CA-125 Response Rate was assessed according to the GCIG criteria
Time frame: Up to approximately 22 months
Number and Severity of Treatment-emergent Adverse Events (TEAEs)
The incidence and severity of TEAEs and TRAEs (Treatment-related Adverse Events, graded according to NCI CTCAE 5.0), Serious AEs (SAEs), laboratory tests, etc.
Time frame: Up to approximately 22 months