This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.
This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.The primary study hypotheses are that the combination of SHR-1210 plus SHR-1020 is superior to SHR-1210 or physician's choice chemotherapy with respect to: 1) Progression free survival(PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus SHR-1210；2) Overall survival(OS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus Physician's choice chemotherapy).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
194
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Objective Response Rate (ORR) assessed by Blinded Independent Central Review in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.
Time frame: Up to approximately 2 years
Progression free survival (PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
PFS is defined as from the time of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Time frame: Up to approximately 2 years
Overall survival (OS) in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
OS is the time interval from randomization to death due to any reason or lost of follow-up.
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) assessed by investigator in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210)
Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.
Time frame: Up to approximately 2 years
Disease control rate (DCR)，recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria
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Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions), PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or SD (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.
Time frame: Up to approximately 2 years
Duration of response (DoR), in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.
For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death from any cause, whichever came first. The DOR per RECIST 1.1 as assessed by Investigator will be presented.
Time frame: Up to approximately 2 years
Time to response (TTR), in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.
Defined as the time from randomization to the first objective tumor response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters)) observed for patients who achieved a CR or PR.
Time frame: Up to approximately 2 years
Time to treatment failure (TTF)，in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria.
Defined as the time from randomization to the end of treatment or death from any cause, whichever came first.
Time frame: Up to approximately 2 years
Adverse Events (AEs)
Time frame: from the first drug administration to within 90 days for the last treatment dose
Tolerance
To calculate the proportion of dose interruption, dose reduction or dose termination because of drug-related toxicity
Time frame: from the first drug administration to within 90 days for the last treatment dose
Characteristic of Anti drug antibody
Defined as ratio of ADAs of SHR-1210 during the treatment compared to baseline.
Time frame: from the first drug administration to within 90 days for the last treatment dose
Peak Serum Concentration of SHR-1210
Defined as peak serum concentration of SHR-1210 during the treatment compared to baseline
Time frame: from the first drug administration to within 90 days for the last treatment dose
Peak Plasma Concentration of famitinib
Defined as peak plasma concentration of famitinib during the treatment compared to baseline
Time frame: from the first drug administration to within 90 days for the last treatment dose
Area under the Serum Concentration versus Time Curve of SHR-1210
Defined as area under the serum concentration versus time curve of SHR-1210 during the treatment compared to baseline
Time frame: from the first drug administration to within 90 days for the last treatment dose
Area under the Plasma Concentration versus Time Curve of famitinib
Defined as area under the plasma concentration versus time curve of famitinib during the treatment compared to baseline
Time frame: from the first drug administration to within 90 days for the last treatment dose