This is A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
445
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Anhui Provincial Hospital
Hefei, China
The Second Affiliated Hospital,Anhui Medical University
Hefei, China
progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST v1.1
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1
Time frame: Up to approximately 2 years
overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR
Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria
Time frame: Up to approximately 2 years
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
Time frame: Up to approximately 2 years
Time to Response(TTR Per RECIST 1.1 as Assessed by BICR
Time frame: Up to approximately 2 years
AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment
Time frame: Up to approximately 2 years
Observed concentrations of AK104
The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
iv infusion
iv infusion
iv infusion
Fudan University Shanghai Cancer Center
Shanghai, China
Time frame: From first dose of AK104 through 90 days after last dose of AK104
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of AK104 through 90 days after last dose of AK104