This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN033 versus investigator's choice of chemotherapy in patients with recurrent or metastatic cervical cancer who have failed platinum-based chemotherapy and PD-1/L1 inhibitor therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
368
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Affiliated Cancer Hospital of Fudan University
Shanghai, China
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 27 months
Overall Survival (OS)
OS was defined as the time from randomization until the date of death from any cause
Time frame: Up to approximately 27 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 27 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 27 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 27 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 27 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)
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Gemcitabine
Pemetrexed
Time frame: Up to approximately 27 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 27 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 27 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 27 months
Patient-reported Quality of Life-European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Patient-reported quality-of-life assessments using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). All scores are transformed to a 0-100 scale. Higher scores represent better function/global quality-of-life status for functional and global health scales, and worse symptom burden for symptom scales.
Time frame: Up to approximately 27 months
Patient-reported Quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer 24 (EORTC QLQ-CX24)
Patient-reported quality-of-life assessments using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer 24 (EORTC QLQ-CX24). All scores are transformed to a 0-100 scale; higher scores indicate worse outcomes for symptom scales, except for sexual activity and sexual enjoyment items where higher scores indicate better outcomes.
Time frame: Up to approximately 27 months
Plasma Concentrations of JSKN003
Measurement of plasma concentrations of JSKN003.
Time frame: Up to approximately 27 months
Plasma Concentration of Total Antibody
Measurement of plasma concentration of total antibody.
Time frame: Up to approximately 27 months
Plasma Concentration of Free Payload
Measurement of plasma concentration of free payload.
Time frame: Up to approximately 27 months
Plasma Concentration of Envotumab
Measurement of plasma concentration of envotumab.
Time frame: Up to approximately 27 months
Incidence and Titer of Anti-Drug Antibodies
Assessment of the incidence and titer of anti-drug antibodies, as applicable.
Time frame: Up to approximately 27 months
Incidence and Titer of Neutralizing Antibodies
Assessment of the incidence and titer of neutralizing antibodies, as applicable.
Time frame: Up to approximately 27 months