An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer
This is a Phase 2, open label, multicohort, multicenter study designed to evaluate the efficacy and safety of combination therapy of AK104, AK112 and chemotherapy in recurrent ovarian cancer. AK104 is a bispecific monoclonal antibody targeting both CTLA-4 and PD-1. AK112 is a bispecific monoclonal antibody targeting VEGF and PD-1.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGObjective Response Rate (ORR) Per RECIST 1.1 as Assessed by investigator
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 2 years
progression-free survival (PFS) assessed by investigator per RECIST v1.1
PFS is defined as the time from the date of first dosing till the first documented disease progression (Per RECIST v1.1 assessed by the investigator) or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
duration of Response (DOR) assessed by investigator per RECIST v1.1
DOR means time 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 2 years
Time to Response (TTR) assessed by investigator per RECIST v1.1
TTR refers to Time to Response.
Time frame: Up to 2 years
Overall Survival(OS)
OS is defined as the time from randomization or first dosing to death due to any cause.
Time frame: Up to 2 years
Number of participants with adverse event (AE)
The number of participants experiencing an Adverse Event (AE) and the severity of AEs will be assessed. AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Time frame: Up to 2 years
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