OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC),peritoneal primary carcinoma, or fallopian tube cancer -Eastern Cooperative Oncology Group (ECOG) performance status of 0,1,or 2 -Life expectancy greater than (>) 12 weeks -Adequate hematologic and end organ function -For participants who receive therapeutic anticoagulation:stable anticoagulant regimen
Exclusion criteria
Exclusion criteria: -Received a current diagnosis of tumors of low malignant potential (borderline epithelial ovarian cancer), or non-epithelial ovarian tumors -Have recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer -Other invasive malignancies with any evidence of other cancers present within the last 5 years with the exception of other specific malignancies(e.g. localized breast cancer) -Pregnant or lactating women -History of autoimmune disease -Have a positive test result for HIV, active hepatitis B or hepatitis C infection -Significant cardiovascular disease -Prior treatment with CD137 agonists or immune checkpoint blockade therapies,anti-PD1,anti-PD-L1,or anti-CTLA4 therapeutic antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Progression-Free survival, Overall survival RECIST v1.1, Observation | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Objective response rate, Safety, etc. RECIST v1.1, Observation, etc. | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, Russian Federation, South America