Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer
An Exploratory, Multi-cohort Phase II Study of Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer
Sponsor: Akeso
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression-free survival (PFS) assessed by investigator per RECIST v1.1
Time frame: up to 2 years
Secondary Endpoints
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by investigator
Disease control rate(DCR)assessed by investigator per RECIST v1.1
Duration of Response (DOR) 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 documented epithelial and non-mucinous PSOC. PSOC was defined as radiographic progression greater than 6 months from last dose of platinum-based chemotherapy. Note: 1. If breast cancer susceptibility gene (BRCA) positive participants must have received prior treatment with a poly adenosine phosphate-ribose polymerase inhibitor (PARPi). 2. Ovarian cancer includes ovarian cancer, fallopian tube cancer and primary peritoneal cancer in this study, unless otherwise specified. 6. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 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. All subjects of reproductive potential…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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