An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer
Signs the written informed consent form.
Female participants who are at least 18 years of age on the day of signing informed consent with.
ECOG of 0 or 1.
Life expectancy ≥ 3 months.
Other pathological types such as mucinous cancer, low-grade serous carcinoma, carcinosarcoma, sex cord stromal cell tumor, etc.
Presence of central nervous system (CNS) metastases or carcinomatous meningitis.
Subjects with uncontrollable pleural, pericardial, or peritoneal effusion requiring repeated drainage.
Patients with other active malignancies within 3 years prior to randomization.
Sequential
AK104
Drugivgtt
AK112
Drugivgtt
Chemotherapy
Drugivgtt
Objective 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
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.
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 to Response (TTR) assessed by investigator per RECIST v1.1
TTR refers to Time to Response.
Overall Survival(OS)
OS is defined as the time from randomization or first dosing to death due to any cause.
