ovarian cancer
Conditions
Interventions
8 weeks per a course, up to 6 courses. 2 doses, lower dose and upper dose will be applied.
Sponsors
Department of Gynecology and Obstetrics, Kyoto University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients who are confirmed as having epithelial ovarian cancer by cytodiagnosis or tissue diagnosis; 2) Patients whose recurrent and advanced ovarian cancers are determined as platinum refractory. 3)Patients who had undergone more than two regimens of chemotherapy including platinum and taxane as pre-treatment and more than 4 weeks must have elapsed from the last administration of antitumor drug. Combination therapy with another platinum or taxane will be considered as one regimen. 4) Surgical therapy and radiation therapy will not be defined as pre-treatment. It is however required that more than 4 weeks must have elapsed from day of surgery and the last day of radiation therapy; 5) Patients with measurable lesions based on RECIST; 6) Patients with ECOG Performance Status of 0-1; 7) Patients with 3 months of life expectancy; 8) Patients who are classified in NYHA Class I and have not received treatment for arrhythmia; 9) Patients, age between20 years and 79 at the time of informed consent; 10) Patients with major organ functions maintained (updated laboratory data obtained within 7 days prior to enrollment meets all the following criteria) WBC 2,000/mm3 Platelets 75,000/mm3 Hemoglobin 8g/dL AST (GOT) 100 IU/L ALT (GPT) 100 IU/L Total bilirubin 1.5mg/dL Serum creatinine 2.0mg/dL 11) Patients who have more than 20 pieces of their paraffin-embedded tumor samples, at least 5m for each section. 12) Patients with written consent forms obtained for participation in this study.
Exclusion criteria
Exclusion criteria: 1) Patients with histories of severe hypersensitive reactions to other antibody drugs. 2) Patients with adverse drug reactions caused by pre-treatment or impacts of complications of surgery or radiation, which are judged to affect the safety assessment of study drug by principle/sub-investigator. 3) Patients with synchronous multiple cancers. 4) Patients with complications of autoimmune disease, histories of chronic and recurrent autoimmune disease or other diseases which require systemic steroid therapy or immune suppressor. 5) Patients with positive test results for HBV, HCV, HIV-1, HIV-2 and HLV-1 antibodies. 6) Patients who are pregnant, nursing or possibly pregnant, or do not agree with contraception until 300 days from the last administration of study drug after informed consent. 7) Patients who received any other study drug or anti-PD-1 antibody within 4 weeks prior to the study drug administration. 8) Patients whom principle/sub-investigator judged ineligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best overall response (Response rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events and adverse drug reaction Progression free survival (PFS) Overall survival (OS) Disease control rate (DCR) | — |
Countries
Japan
Contacts
Public ContactJunzo Hamanishi
Kyoto University Hospital Gynecology and Obstetrics
Outcome results
None listed