An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer
Sponsor: Akeso
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by investigator
Time frame: Up to 2 years
Secondary Endpoints
progression-free survival (PFS) assessed by investigator per RECIST v1.1
duration of Response (DOR) assessed by investigator per RECIST v1.1
Time to Response (TTR) assessed by investigator per RECIST v1.1
Eligibility Criteria
Inclusion Criteria: 1. Signs the written informed consent form. 2. Female participants who are at least 18 years of age on the day of signing informed consent with. 3. ECOG of 0 or 1. 4. Life expectancy ≥ 3 months. 5. Histologically diagnosed high-grade epithelial ovarian cancer (including high-grade serous, clear cell, G3 endometrioid) that has relapsed after platinum-containing standard chemotherapy. 1. Recurrence of Platinum-sensitive (relapse ≥6 months after the end of platinum-containing therapy) who is not suitable for platinum-containing therapy after ≥ 3 lines of therapy; 2. Recurrence of platinum resistance , ≤3 previous lines of therapy. Note: Ovarian cancer includes ovarian cancer, fallopian tube cancer and primary peritoneal cancer in this study, unless otherwise specified. 6. Has measurable disease based on RECIST v1.1 as determined by the site study team. 7. Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue. 8. Has adequate organ function. 9…
Read full criteria on CT.gov →✦ Analyst Commentary
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