Unresectable or metastatic renal cell carcinoma
Conditions
Interventions
None listed
Sponsors
Graduate School of Pharmaceutical Sciences Department of Urology, Graduate School of Medicine Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Cases with renal cell carcinoma histologically or pathologically 2)Patients with unresectable or metastatic renal cell carcinoma 3)Adequate organ function.
Exclusion criteria
Exclusion criteria: 1)Patients with known or previous antoimmune disease 2)Patients who are currently administered corticosteroids 3)Patients with prior therapy by antibody or drug, specifically aiming at regulation of T-cell functions 4)Patients with history of serious anaphylaxis induced by the component of this agent 5)Dementia or psychological disorder difficult to participate in this clinical study 6)Patients with severe complications (active gastrointestinal ulceration, ileus, bowel obstruction, and uncontrolled diabetes mellitus, etc.) 7)Patients with HIV antibody-positive, HBs antibody-positive, or HCV antibody-positive 8)Patients with HBs antigen-negative, HBs antibody- or HBc antibody-positive, and HBV-DNA quantitative test-positive 9)Pregnant or breast-feeding women or women suspected of being pregnant 10)Other cases judged inappropriate by the attending
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival at 6 months after Nivolumab administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Overall survival Safety: Rate of side effects | — |
Countries
Japan
Contacts
Public ContactKazutake Tsujikawa
Graduate School of Pharmaceutical Sciences, Osaka University Laboratory of Molecular and Cellular Physiology
Outcome results
None listed